Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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More State Lawmakers – Seemingly Having Nothing Better to Do – Push Bills to Allow Off-Label Drug Promotion

More State Lawmakers – Seemingly Having Nothing Better to Do – Push Bills to Allow Off-Label Drug Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Over the past month, lawmakers in three states — Missouri, Colorado, and Mississippi — have introduced bills that would allow drug makers to promote their medicines for so-called off-label uses, so long as the information given to doctors is truthful.

 

The efforts come less than a year after Arizona adopted such a law, making it the first state in the U.S. to permit off-label promotion. The bills also arrive amid ongoing pressure on the Food and Drug Administration to loosen regulations for off-label promotions, which is one of the most contentious issues to roil both the agency and the pharmaceutical industry.

 

At issue is a fierce debate over patient safety and free speech.

 

Doctors can prescribe a medicine for an off-label — or unapproved — use, but drug makers have battled restrictions on their ability to distribute such information, such as reprints of medical studies. The companies believe free speech is being curtailed and have lobbied Congress and the FDA to loosen regulations. For its part, the FDA worries public health can be jeopardized by promotions that go too far.

 

As we noted previously, drug makers were emboldened by a pair of court rulings in recent years that determined companies can disseminate off-label information, so long as it is truthful and not misleading. But one decision, which was issued by a federal appeals court, extends only to Connecticut, New York, and Vermont, creating uncertainty about whether the issue would be tested elsewhere.

 

“States have more important things to legislate, such as what is the official state tree, which would have more consequence and statewide impact.” - PETER PITTS, CENTER FOR MEDICINE IN THE PUBLIC INTEREST

 

The FDA, meanwhile, has not yet taken any action. A year ago, the agency issued a memo that, instead of suggesting possible solutions, simply summarized key points framing the long-running debate and carefully rebuffed many of the suggestions made by drug makers and others that support expanding pharmaceutical marketing.

 

As a result, the Goldwater Institute, a libertarian think tank, is helping to fill the void.

 

The Arizona law was conceived by the institute, which spearheaded the controversial right-to-try movement designed to give patients access to experimental medicines. The institute vowed to duplicate that campaign by introducing off-label bills around the country and a Goldwater spokeswoman noted the new bills are based on its models. The institute is also supporting the legislation, Naomi Lopez Bauman, director of healthcare policy, told us.

 

Further Reading:

  • “Arizona First State to Pass Law Allowing Pharma to Promote Drugs Off-label to Docs”; http://sco.lt/8HKcPR
  • “Doctors Funded by #Pharma Promote Easing of FDA Regulations Prohibiting Off-Label Promotion of Drugs”; http://sco.lt/5z4LJ3
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Doctors Funded by #Pharma Promote Easing of FDA Regulations Prohibiting Off-Label Promotion of Drugs

Doctors Funded by #Pharma Promote Easing of FDA Regulations Prohibiting Off-Label Promotion of Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One thing industry representatives can’t talk about is “off-label” uses of drugs. These are uses not officially approved by the FDA. Some drugs have powerfully positive off-label effects. Topamax, a seizure drug, can help with alcohol dependence. The blood pressure drug prazosin can help treat post-traumatic stress disorder.

 

Doctors benefit from hearing about such off-label uses, as they inform doctors about alternative uses of medications. However, existing law essentially bans industry reps from discussing off-label uses — even those that are widely popular in the medical community and proven to be effective and safe. Preventing sales reps from mentioning these uses can be detrimental to patients, especially considering that some conditions have no FDA-approved treatments. In these situations, off-label uses can be doctors’ only option for prescribing. Patients would benefit from having physicians be as informed as possible about effective off-label uses.

 

Allowing industry reps to discuss off-label drug use does not mean drug detailing should be unregulated. Drug companies and doctors alike have suffered major lawsuits for promoting drugs not approved by the FDA — in some cases significantly understating the risks of these medications to patients. The government needs to ensure that pharmaceutical reps share factual information that helps doctors make informed decisions, not advertise unsafe medications.

 

I’ve seen firsthand how industry-sponsored drug education can empower doctors with information about the newest treatments and ensure that patients have access to the best possible medicines. As lawmakers dig into the issue, they should ensure that information is exchanged responsibly. Lawmakers should avoid passing new legislation that further limits physicians’ understanding of which drugs can best benefit their patients. Better yet, they can sponsor policies that help facilitate objective information sharing, including that about off-label uses, between doctors and drug detailers.

Pharma Guy's insight:

This article claims that physicians need pharma to tell them about off-label uses of drugs. Why was this blatant promotional piece - originally titled "How pharma sales reps help me be a more up-to-date doctor" - published in STAT?

 

Robert Yapundich, M.D., is a neurologist practicing in Hickory, N.C., and a member of the Alliance for Patient Access. In 2015, he received $134,792 from 26 different pharma companies. The Alliance for Patient Access is probably funded in large part by pharmaceutical companies - it's Form 990 B lists contributions as "restricted" - that is, not available for viewing. It gets other funding through education programs for physicians who are probably paid by pharma to attend! Nice!

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Arizona First State to Pass Law Allowing Pharma to Promote Drugs Off-label to Docs

Arizona First State to Pass Law Allowing Pharma to Promote Drugs Off-label to Docs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label uses — so long as the information given doctors is truthful.

 

Interestingly, the law was hatched by the Goldwater Institute, the same think tank that spearheaded the controversial Right to Try laws designed to give patients early access to experimental medicines. And the think tank is vowing to duplicate that campaign by introducing off-label bills around the country.

 

This move comes amid rising pressure on the Food and Drug Administration to loosen regulations for off-label promotions, which is one of the most contentious issues to roil both the agency and the pharmaceutical industry. At issue is a fierce debate over patient safety and free speech.

 

Meanwhile, though, one former FDA official, who has publicly urged the FDA to loosen its regulations, believes such state laws would be useless, because they would be preempted by federal law that allows the FDA to issue guidance documents and rules about various activities and requirements.

 

“It’s nice that the Arizona legislature thinks disseminating off-label information is a good thing, but it’s not their jurisdiction to say so,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry. “I don’t think a challenge in court would last more than five minutes.”

 

Nonetheless, one consumer advocate, who opposes widening the ability of drug makers to promote off-label uses, fully expects the Goldwater Institute to persist.

 

“I don’t think the law will change the landscape, but they’re seeking to gin up public attention and become a stepping-stone to try to get Congress to pass laws that would accomplish the same thing on a national level,” said Michael Carome, who heads Public Citizen. “I suspect that’s the ultimate goal.”

 

Further Reading:

  • “Does FDA Guidance About Pharma Communications with Payors Open a Path to Off-Label Discussions?”; http://sco.lt/6jzBqb 
  • “WLF Urges FDA to Abide by First Amendment, Lift Restrictions on Off-Label Communications”; http://sco.lt/54EzSb 

 

Is "Right to Try" a good idea? Take my survey here: https://www.surveymonkey.com/r/2D8MM5L

Pharma Guy's insight:

This ties the "right to try" movement with the push by pharma to promote drugs off-label.

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Here’s What Big Pharma Will Likely Get From a “Deal” with Trump

Here’s What Big Pharma Will Likely Get From a “Deal” with Trump | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Congressman Greg Walden, a key House Republican for pharmaceutical policy, suggested this week that President Trump wants to encourage drug makers to enter value-based contracts with private health plans and the government insurance programs. Maybe that’s what the president has meant all along in his vague promises to change bidding and negotiations.

 

If that’s true, the drug industry could actually see some federal policy changes it has long sought.

 

But the companies argue existing rules limit their ability to enter into these kinds of agreements. If Trump is serious about pursuing them, some changes might be necessary, changes drug companies would likely welcome.

 

A few hurdles stick out.

 

Drug makers say that federal anti-kickback statutes restrict their ability to talk with payers and patient groups before a drug is on the market. Those rules are intended to prevent any illicit financial arrangements, but the industry believes they have a chilling effect on new payment models. There are also Food and Drug Administration regulations limiting what they can communicate about their products.

 

Both sets of restrictions have to be accounted for if companies explore value-based contracts with federal insurance programs or private insurers. So, the thinking goes, allowing more open pre-sale communication could facilitate more of those arrangements.

 

“Will FDA Open a Path to Off-Label Promotion from Pharma to Payers & Not Patients or Providers?”

 

In the private market, there is another obvious target for reform, one that drug companies have been focused on for a while.

 

A Medicaid rule requires drug makers to offer discounts based on the “best price” — the lowest price — that any purchaser in the country pays for the drug. The lower that price, the bigger the discount. Drug makers argue that this rule discourages them from entering into value-based contracts that could drive the “best price” lower — because then they’ll have to provide a bigger discount to the entire Medicaid program.

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Allowing Pharma Sales Reps to Discuss Off-Label Drug Use Would Make Them More Helpful, Says KevinMD

Allowing Pharma Sales Reps to Discuss Off-Label Drug Use Would Make Them More Helpful, Says KevinMD | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the past, pharma reps were a source of samples that I could provide to my poorer patients who could not afford their meds. This was a real value: I depended on reps to provide these medications for my patients. In the days of print-only access to journals, I may not have been as current with the medical literature. Reps would often come in and discuss breaking trial news that I had not yet had time to read about. Often they would discuss upcoming trials and plans for the future. We would have spirited “academic” debates over drugs, trial design, and outcomes or endpoints. When you were unable to attend scientific meetings, the pharma rep would often be able to summarize the latest trials after they were released.

 

Now, my institution no longer allows samples to be left, and honestly, if I need a drug rep to share the latest data with me then I am not doing my job as a physician. Online access to immediate data from trials upon their release makes keeping current much easier. Social media and other digital tools make it possible to attend national academic meetings such as the American Heart Association annual scientific session or the American College of Cardiology meetings allow everyone to be virtually present for groundbreaking presentations of late-breaking clinical trials.

 

Don’t get me wrong, there is nothing wrong with the people who choose to be pharma reps: Many are smart, classy, well-meaning folks. However, there is a lot wrong with the antiquated pharma rep sales model in today’s world. Modern technology and easy access to data allow physicians to keep up with the latest clinical trials. Pharmaceutical detailing by reps is not very helpful; it is scripted and based solely on what the FDA allows them to say (think on label vs. off label). Reps are not allowed to talk about upcoming trials or discuss any off-label applications.

Pharma Guy's insight:

The last sentence in this scoop suggests that the only way that sales reps will regain their influence in today’s world is if they can talk to docs about upcoming trials and off-label applications of drugs. That may soon happen. Read more about FDA and off-label communications here: http://bit.ly/offlabelscooped 

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Off-Label DTC Advertising Survey Results: Presentation at FDA

Off-Label DTC Advertising Survey Results: Presentation at FDA | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Results from a survey of Pharma Marketing News readers & twitter followers of @pharmaguy to be presented at FDA public hearing on November 9. 2016 at 2:38 PM. More info here.

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How Endo Pharmaceuticals Got Caught Promoting an Orphan Drug "Off Label"

How Endo Pharmaceuticals Got Caught Promoting an Orphan Drug "Off Label" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Truth In Media Project has released the last segment of of its newest series Truth In Media: Big Pharma, The FDA & Health Propaganda. Part 4, titled How Big Pharma Uses Off-Label Drugs, illustrates how pharmaceutical companies have made massive profits in spite of being ordered to pay enormous settlements related to harmful side effects of certain drugs.

Truth In Media’s Ben Swann first discussed the case of Peggy Ryan, a pharmaceutical sales representative for Endo Pharmaceuticals, who spent a decade undercover gathering information and ultimately blowing the whistle on corruption within the company.

Ryan, described as a “rising star” at Endo, said that she had been pressured and directed to push a product called Lidoderm, which was initially created to treat a specific condition called post-herpetic neuralgia. Since Lidoderm was approved to be prescribed only for this condition, the drug was classified as an “orphan drug,” which qualifies a drug to be subsidized by taxpayer dollars in its approval and production to offset low profits related to producing a product that is prescribed to a limited number of patients.

Swann pointed out that the FDA does not monitor orphan drugs for side effects once approved.

Ryan said she was instructed to sell the drug “off-label,” meaning to sell the drug to be used conditions outside of its intended use. Lidoderm ended up being prescribed for a plethora of unapproved health issues including back pain and carpal tunnel syndrome. Many of these prescriptions were covered by Medicare and Medicaid.

“She had access to a lot of information, and she provided that to the government. But then they asked her to wear a wire and obtain audiotapes of the people that she reported to telling her and other employees to essentially to break the law,” Judy Hoyer, a whistleblower attorney whose firm represented Ryan, told Swann.

Endo was ordered to pay $193 million in penalties in a settlement; $21 million was allocated to settle criminal charges, and $172 million was paid out under the False Claims Act. While $193 million is certainly a large sum of money to be paid, Endo made at least $1 billion selling the drug off-label; the penalty paled in comparison to the profits made.

In a separate case that also involved massive drug sale profits in light of little government oversight, highly-cited researcher, doctor and Emory University Professor Doug Bremner discussed the acne drug Accutane with Swann. Bremner, who has spent a great deal of time researching PTSD and depression and the brain, served as an expert witness in litigation proceedings associating depression and suicide with Accutane.

Pharma Guy's insight:

Also read: “How Big Pharma Courts Physicians & Makes Them Look Like They Have a Lot of Money!”; http://sco.lt/6w3HWL

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25 Years of Pharma Criminal and Civil Penalties: Off-Label Marketing Tops the List, But...

25 Years of Pharma Criminal and Civil Penalties: Off-Label Marketing Tops the List, But... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to a Public Citizen report, stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs. The report – an update to a previous study released in 2012 with additional data through 2015 – catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2015, which totaled $35.7 billion.

Of the 373 settlements over those 25 years, 140 were federal settlements totaling $31.9 billion, and 233 were state settlements totaling $3.8 billion. GlaxoSmithKline and Pfizer reached the most settlements and paid the most in financial penalties – $7.9 billion and $3.9 billion, respectively. From 1991 through 2015, 31 companies entered into repeat settlements with the federal government. The violation resulting in the most federal penalties was unlawful promotion, usually off-label marketing.

There is one surprising result. More...

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Brave New "Mind-Bending" Off-Label #Pharma Marketing

Brave New "Mind-Bending" Off-Label #Pharma Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The FDA has settled a landmark case in off-label promotion, giving a company the legal right to promote their drug for unapproved uses, as long as the data “is truthful and non-misleading.” What does this mean for the industry, and what should pharma marketers do?

Is each off-label case an isolated instance with unique circumstances, or is the litigation trending in a manner suggestive of a potential paradigm shift in how prescription drugs can and will inevitably be marketed?

The pressure is clearly building: in one corner, the FDA understandably wants to preserve its essential role as the official arbiter of safety and efficacy for prescription drugs; in the other, pharma companies want to share additional clinical data shown to be “truthful and non-misleading” with physicians who ostensibly are already hungry for it. To appease both sides, a comprehensive policy designed to guide industry practices is needed; a third-party review entity has even been suggested, but the onus is clearly on the FDA to make the next move.

 

What should we do during this intriguing but confusing transition?

A great place to start is by taking a look at how the two brands that have gone through litigation already handle off-label promotion. The VASCEPA website, for example, features the ANCHOR study results for the expanded “persistently high” plus statin patient population with equal prominence as the FDA-approved MARINE study; language that would give experienced pharma marketers pause includes “Data reviewed and confirmed by the FDA—indication not approved by the FDA.” How’s that for a mind-bender?

A telling footnote cites the federal court order allowing the off-label data to be used:

The EXPAREL website is similarly exotic to the eyes of traditional pharma marketers who have learned to live and breathe approved use only, the site devoting an entire page to “important new information” about the drug, including its use “in a variety of surgeries not limited to those studied in its pivotal trials,” along with a message from the company CEO regarding their “successful collaboration with the FDA to resolve this matter” to ultimately provide an “option like EXPAREL to as many patients as appropriate.”

What’s fascinating in both instances is how the off-label promotional content is seamlessly embedded within the conventionally approved content. Standard fair balance in the form of a global ISI containing the approved indication is as you would normally expect, with the off-label data specified as such, yet placed with equal weight and no other overtly distinguishing characteristics. Moving forward, might such lack of differentiation prove problematic, potentially construed as “misleading”? Brave new pharma marketing world indeed!

Pharma Guy's insight:

Also read: "FDA Deal with Amarin: Does It Mean More or Less Off-Label Promotion?"; http://sco.lt/96r3HV 

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FDA Deal with Amarin: Does It Mean More or Less Off-Label Promotion?

FDA Deal with Amarin: Does It Mean More or Less Off-Label Promotion? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration may have reached a first-of-its-kind settlement allowing Amarin to promote its prescription fish-oil pill for unapproved uses, but experts say other drug makers are unlikely to quickly engage in off-label marketing.

“This is an interesting development, but I don’t think it changes how companies can market their drugs,” said Patti Zettler, a former FDA associate chief counsel who is now a Georgia State University College of Law professor. “It’s an agreement only between Amarin and the FDA. But it might give companies some ammunition to negotiate with FDA and say they should be allowed to do the same thing.”

In its lawsuit, Amarin argued that FDA regulations are not only onerous, but prevent physicians from obtaining information from the “most knowledgeable sources — the drug manufacturers.” Four doctors joined the lawsuit, which noted they had been prescribing Vascepa off-label to people with varying levels of triglycerides.

Nonetheless, the settlement is unlikely to signal a rush of off-label promotion. Another expert noted that the agreement only pertains to Amarin, which had clinical trial results to support its claims about its pill. This suggests that other drug makers would likely need the same caliber of information should they consider off-label promotion.

The settlement may provide momentum for a recent proposal to create a new independent entity to review off-label claims and recommend which information drug companies should be allowed to share with doctors.


[A think tank at Duke University called (http://sco.lt/5mZaL3) for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.]


For its part, the FDA has repeatedly said it would hold a meeting to review the issue and, later this year, release a new guidance for companies. Specific dates, however, have not been disclosed.

Pharma Guy's insight:

I disagree with the "experts" and believe this decision WILL change how the drug industry markets drugs to physicians. There have been other court cases that support the promotion of off-lable use of drugs, so this is not the only case. The industry is already planning ways to expedite the review process with the FDA (e.g., the Duke "Think Tank") and now that Califf (a former Duke employee) is FDA commissioner it is a sure bet that this issue will be a top priority at the FDA in terms of new guidance.

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Pharma Guy's curator insight, March 28, 2016 8:07 AM

I disagree with the "experts" and believe this decision WILL change how the drug industry markets drugs to physicians. There have been other court cases that support the promotion of off-lable use of drugs, so this is not the only case. The industry is already planning ways to expedite the review process with the FDA (e.g., the Duke "Think Tank") and now that Califf (a former Duke employee) is FDA commissioner it is a sure bet that this issue will be a top priority at the FDA in terms of new guidance.

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To Avoid "Chaos," Wonks Propose Non-FDA Panel “Rank, Score, or Grade” Off-Label Communications

To Avoid "Chaos," Wonks Propose Non-FDA Panel “Rank, Score, or Grade” Off-Label Communications | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nature abhors a vacuum. … absent strong and forward-looking FDA leadership, the off-label debate will result in public health chaos.

 

And, as many management gurus have written, one of the key tenets of successful leadership is the ability to delegate in order to get things done. To that end, one of the more contentious policy recommendations made in the paper is for the FDA to pursue a strategy that embraces third party sanctioned communication.

 

This alternative, which did not have universal support within our working group, involves a more intramural approach based on the FDA’s partnering with an external entity charged with accrediting certain types of communication.

 

This organization could focus its efforts on reviewing not an NDA, but an NDI – New Drug/Device Information, consisting of a sponsor’s evidence and associated communications about off-label use, and then potentially approve them for broader distribution.

 

An NDI review could be given within a rank, score, or grade system that confers greater weight to better evidence, and could be given contingent upon continued evidence generation and resubmission to the clearing body.

 

For example, an off-label communication may be approved and given an initial grade or rating that sunsets within a specified number of years barring updated submission of relevant evidence. Continued off-label communication at the current evidentiary grade and after the specified date would then be subject to additional evidence development by the sponsor.

 

The proposed reviewing body would operate outside of FDA but with FDA participation. To avoid First Amendment and other legal concerns, the body’s conclusions could not bind the FDA or otherwise hinder FDA’s ability to pursue enforcement action. While the reviewing body would not provide certainty to the regulated community, its recommendations could offer useful guidance to drug manufacturers.

 

Those new options are detailed in a new paper: “Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care”

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Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?"

Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the Amarin court case, the court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of the drug Vascepa that aren't covered by the drug's FDA-approved labeling -- as long as the information is true and not misleading (read "Amarin Wins Off-Label Case Against FDA"). This case is likely to influence new guidance from the FDA regarding off-label drug promotion by pharma marketers. 

"Might changes in rules for promotion of off-label indications based on free speech arguments lead to a situation akin to crying fire in a crowded theater?," asks authors of Commentary published in the recent issue of JAMA Internal Medicine. The authors of the commentary -- Chester B. Good, M.D., M.P.H., and Walid F. Gellad, M.D., M.P.H., of the Veterans Affairs Pittsburgh Heathcare System -- referred to "compelling evidence" that "off-label prescribing is frequently inappropriate and that prescribing in these circumstances increases the risk for an adverse event substantially."

That evidence was presented in a study published in the same issue of the journal titled "Off-label Prescription Drug Use and Adverse Drug Events" (JAMA Intern Med. Published online November 2, 2015. doi:10.1001/jamainternmed.2015.6058).

What is the "compelling evidence?" Find out here.

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How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use

How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In November 2000, Johnson & Johnson research scientists got troubling numbers related to the goal Gorsky and his team had set at the Risperdal “Brand Strategic Planning” meeting two years earlier. They had hoped that the scientists would generate data that would rebut the competition’s claim that Risperdal raised levels of the hormone prolactin to a degree that could cause young boys to grow breasts. But the largest study done yet by J&J of the effects of long-term Risperdal use among children and adolescents—in which, according to the study’s protocol, “special attention” was paid to prolactin—had now found that of 319 children, including 266 males, 8.6 percent of the males had developed gynecomastia, or breasts. When the final results including more participants were tabulated, the percentage of males was 5.5 percent.


Five and a half-percent was a big number. If 400,000 boys took Risperdal, that would mean 22,000 might end up with breasts. Attention deficit disorder was no picnic, but doctors and parents might not think treating it was worth those odds of their son having to wear a bra. And that risk was in addition to all the other known side effects already listed on the Risperdal label, such as somnolence, nausea or significant weight gain.


An updated Risperdal business plan that management signed off on in September 2000 unabashedly signaled that Johnson & Johnson would ignore the regulators and any bothersome data and keep going after children.


hildren and adolescents were now the fastest growing segment of the market—and they accounted for 21 percent of all Risperdal users. The second fastest uptick was in the geriatric market, which comprised 25 percent of all Risperdal users. That meant markets that J&J was forbidden from promoting to accounted for 46 percent of all sales in the year 2000, a percentage that was likely to grow quickly because, as the plan noted, the legitimate market, schizophrenic adults, was “flat.” In fact, a study later published by the Journal of the American Medical Association would put the off-label percentage at 66 percent in 2001.


The plan then mapped steps to be taken in the coming year to “grow and protect share in child/adolescents via medical education initiatives and effective [sales] rep-targeting, with a year-end exit share of 70%.” Respected doctors—called “Known Opinion Leaders,” or “KOLs”—would be paid to “drive pediatric acute medical education” with a blizzard of J&J-financed articles, symposiums and supporting PR.


Pharma Guy's insight:

According to the DOJ, Gorksy was the "go-to guy" when it came to illegal kickbacks made to nursing home pharmacies for prescribing Risperdal, and "no one else possesses the same level of knowledge." http://bit.ly/pgdaily111313-2 


So how come Gorsky never went to jail? Could it be possible that DOJ and Gorsky actually negotiated these settlements in such a way as to keep Gorsky insulated from criminal charges? There may have even been one or two phone calls between Gorsky and Attorney General Holder to discuss this. One such call might have gone like this: 

Gorsky: Let me tell you the reason I’m calling. I'm a little concerned about some . . . criminal charges stuff. Like, that maybe you guys are thinking of, uh, bringing criminal charges against ME personally. 

Holder: Yeah, we’re definitely thinking of doing that. 

Gorsky: Huh. And this is something you feel strongly about? 

Holder: Pretty strongly, yeah. 

Gorsky: I see. And you have, like, evidence and stuff? 

Holder: I can’t really talk about that, but yeah . . . like, boatloads. 

Gorsky: So listen, do you ever . . . 

Holder: What? 

Gorsky: Do you ever . . . do you ever look out the window in the late afternoon and just get . . . sad? Like, for no reason? 

Holder: Nope. 

Gorsky: Really? Anyway, in terms of a fine . . . 

Holder: Yeah?

Gorsky: I was talking with some of the guys here and we were thinking, like, a Billion maybe would be good. Do you think that would be a good number? Without charging me with a felony or even a misdemeanor, that is. 

Holder: Hmmmmm... 

Gorsky: Oh. What were you thinking, hypothetically? 

Holder: Hypothetically? Not less than FIVE to SIX Billion, including federal and state lawsuits.

Gorsky: Yikes! Does it really have to be that much? If it were say $3.1 Billion, it would be the highest fine paid by a pharma company to the US government and it would give you great creds. 

Holder: That's true, but we can't forget the states. Tell you what, let's announce a 2.2 Billion settlement against J&J for drug-related violations and later announce a $2.5 billion fine to settle the device violations without a hint of an extra lien of $0.6 Billion to cover Medicare/Medicaid liens. The $2.2 Billion figure would include $1.6 Billion against Janssen… but we'll hide that in the details so it won't look so bad for you who used to be President of Janssen.

Gorsky: Whew! Convoluted! O.K., then. Well . . . I should probably talk with my lawyers. 

Holder: Yes, you talk to your lawyers. 

Gorsky: Dinner soon? 

Holder: Can’t wait.

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Fueling the Opioid Epidemic: A “Key Strategic Imperative” for Insys #Pharma

Fueling the Opioid Epidemic: A “Key Strategic Imperative” for Insys #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In early 2015, an Insys Therapeutics employee called an insurer and provided misleading patient information in order to win clearance for a prescription for its Subsys painkiller. The conversation — in which the employee pretended to call from a physician’s office — was about a woman named Sarah Fuller, whose family later claimed she died because she was inappropriately prescribed the drug.

 

The phone call was made scarcely a year after a consultant warned the drug maker that it lacked needed policies for governing such activities, but Insys executives failed to take corrective action, according to U.S. Sen. Claire McCaskill (D-Mo.), who released a copy of the consultant’s report and a recording of the phone call as part of an ongoing investigation into the opioid crisis (see report here: http://freepdfhosting.com/5deb5ac1db.pdf).

 

The details of both the phone call and the report help flesh out what is already a disturbing picture of unchecked pharmaceutical marketing that has emerged from a growing raft of documents in criminal cases and civil lawsuits involving the beleaguered drug maker. And the report arrives as opioid makers, in general, are accused of deliberately downplaying risks and improperly encouraging prescribing.

 

To boost prescriptions for Subsys, which contains the highly addictive fentanyl opioid, Insys allegedly employed numerous tactics. These included a familiar page from the pharmaceutical playbook in which some physicians were rewarded with speaking fees and other forms of compensation for writing outsized numbers of prescriptions, according to court documents.

 

Central to the Insys marketing plan, however, was a so-called reimbursement center, which was created specifically to contact insurers and persuade them to authorize prescriptions. In the health insurance world, prior authorization is an extra step that insurers use to weed out unnecessary prescribing. Often, this proves to be a challenging hurdle, especially when a medicine is pricey.

 

But Insys created this “center” because many insurers and pharmacy benefits managers often declined to green-light prescriptions that were not for breakthrough cancer pain patients. Authorities say the company sought to widen the market for its drug by illegally inducing doctors to prescribe the pill for other sorts of pain. This is known as “off-label” prescribing, which doctors are permitted to do.

 

An Insys spokeswoman did not respond to a request for comment.

 

Further Reading:

Pharma Guy's insight:

A smoking gun if ever I saw one!

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Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs

Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

 

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

 

The Celgene settlement is the latest in a string of multimillion-dollar fines that pharmaceutical companies have paid to settle charges that they inappropriately marketed certain drugs in recent years, but this case is one of the largest settlements to involve a cancer drug, said Reuben A. Guttman, who represented the whistle-blower, Beverly Brown.

 

Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.

 

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

 

Brian Gill, a spokesman for Celgene, which is based in New Jersey, said in a statement on Tuesday that the company denied any wrongdoing and said it was “settling to avoid the uncertainty, distraction, and expense of protracted litigation.”

 

For background, read:

  • “A Pharma Marketing "Bait-and-Switch" Scheme: Sales Reps Disguised as Medical Science Liaisons”; http://bit.ly/Mxr9I3
  • “Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion”; http://sco.lt/5kJeZV

Pharma Guy's insight:

The CEO of Celgene looks like Bruce Willis! :) But he's no "good guy"!

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Vascepa: Amarin's Yellow Brick Road to the American Heart Association

Vascepa: Amarin's Yellow Brick Road to the American Heart Association | Pharmaguy's Insights Into Drug Industry News | Scoop.it

 

A decision by the American Heart Association to invite the Amarin chief executive to chair its annual gala, which will have a “Wizard of Oz” theme, is causing a flap worthy of the Wicked Witch.

 

Why? Amarin itself is controversial for the aggressive approach it’s taken toward promoting its prescription fish oil pill for lowering high triglycerides levels. The company filed a lawsuit two years ago against the Food and Drug Administration after the agency rejected its bid to market the pill for people with slightly lower levels, which is an unapproved use (read “Amarin Wins Off-Label Case Against FDA; Vows to Promote Viscera Off Label "’ASAP’"; http://sco.lt/8GzPDV).

 

The lawsuit caused a sensation amid mounting pharmaceutical industry complaints that the FDA squelches free speech (read “FDA May Soon Be Replaced by Judicial Off-Label Activism”; http://sco.lt/7J3xyr). The agency subsequently settled the case, allowing Amarin to promote its Vascepa pill for this unapproved use to physicians. But some believe that, by tapping Amarin’s John Thero, the AHA appears to be unwisely endorsing the company’s tactics and its drug.

 

Dr. Harlan Krumholz, a Yale University cardiologist, tweeted:

 

“One wonders if American Heart Assoc might have been able find chair for their ball w/less baggage an effective evidence-based med.”

 

Meanwhile, in a March 21 press release announcing the gala, AHA senior vice president Kathy Kauffman gushed that Amarin and its CEO “bring passion and great leadership to the Heart & Stroke Ball.” Moreover, the press release was jointly released by the drug maker and the AHA, a move that an AHA spokesperson admitted was a mistake in comments to CardioBrief, which first reported about the gala.

 

In fact, as CardioBrief pointed out, Amarin contributed $60,000 to the AHA during its 2016 fiscal year, although in fairness, the drug maker was one of approximately 50 companies that donated more than $29 million to the organization. One patient advocate suggested the praise in the news release and the corporate contribution gave the impression of an improper relationship.

 

So what does the AHA have to say for itself? More…

 

Further Reading:

Pharma Guy's insight:

File this under “If they only had a brain.”

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Pharmaguy's Top Five 2017 New Year's Resolutions for the Pharma Industry

Pharmaguy's Top Five 2017 New Year's Resolutions for the Pharma Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As is my tradition – as well as the tradition for many other editors/pundits – it’s time for me to tell pharma what I’d like to see included in its list of 2017 New Year's Resolutions.

Last year I noted that 2015 wasn’t an especially good year considering that “the media and politicians have found a face for evil pharma and rising drug prices: Martin Shkreli!” (here).

It’s déjà vu all over again! Only this time many more evil pharma faces have come forward including the CEO of Mylan, aka “Pharma Sis” (read “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”), and top executives at “Crooked Valeant” (read “More Top Executives Flee Sinking Crooked Valeant Ship with $ Millions in Bonuses In Tow”).

 

Before getting to this year's resolutions, let's see if the industry followed any of the resolutions I suggested for 2016. More...

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Off-label Promotion by the Numbers: Settlements, Warnings, Fines, % Prescribed

$3 billion
GlaxoSmithKline paid $3 billion in July 2012 to resolve criminal and civil liability for promoting antidepressants Paxil and Wellbutrin for unapproved uses. In the same settlement, the company also pled guilty for failing to report safety data for diabetes drug Avandia. It remains the largest healthcare fraud settlement in U.S. history.

105 violations
According to a Public Citizen report from March, unlawful promotion was the second most commonly cited violation in settlements involving the pharma industry from 1991 through 2015, with 105 incidents. The lobbying organization defines unlawful promotion to include off-label promotion of drugs as well as other deceptive marketing practices.

42 warnings
Forty-two of the 177 regulatory letters issued by FDA from 2003 to 2007 were in response to off-label promotion, totaling 19 untitled letters and 23 warning letters. Off-label promotion was the third most common violation during that period.

21 settlements
Between 2004 and 2010, the government settled 21 cases over allegations of off-labeling marketing of drugs. Drugmakers were required to enter corporate integrity agreements in 81% of those cases.

12%
Twelve percent of the drugs doctors prescribe are for unapproved uses, according to a JAMA Internal Medicine study from 2015.

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Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion

Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The modern drug-regulation system traces back to a once-popular morning-sickness pill whose linkage to babies born with flipper-like limbs in the 1960s led the U.S. to tighten oversight for approving medications.

 

That makes it all the more amazing that Celgene Corp. has built itself into a biotech powerhouse, rebranding the drug thalidomide using a slightly different name: Thalomid. Recently unsealed documents in a lawsuit by a company saleswoman-turned-whistleblower allege that its success is due to an aggressive campaign to encourage doctors to prescribe it and successor drugs to treat maladies beyond those the FDA authorized.

 

After some studies suggested thalidomide could treat blood cancer but long before it was authorized for it, Celgene created a thriving market by hiring doctors to tout uses beyond what the product was approved for and ghostwriters to promote the drug in medical journals, according to the suit (read "A Pharma Marketing 'Bait-and-Switch' Scheme: Sales Reps Disguised as Medical Science Liaisons”). Though doctors have broad latitude in prescribing drugs, even for uses that aren’t approved, drugmakers can’t push “off-label” uses.

 

Manufacturers including Pfizer Inc. and Johnson & Johnson have paid billions of dollars to settle such claims.

 

Even after the Food and Drug Administration approved Thalomid for multiple myeloma, a blood cancer, in the mid-2000s, Celgene continued to promote it for other forms of cancer, including cervix, thyroid and brain, whistleblower Beverly Brown alleges in the suit, filed in 2010.

 

Celgene vigorously disputes the allegations.

 

Although the U.S. Justice Department declined to join Brown’s suit, which claims Celgene defrauded government insurance programs by marketing its drugs for off-label uses, a California judge cleared her case for trial.

 

“These allegations, which date as far back as 15 years, are baseless,” Celgene spokesman Brian Gill said in a statement. “Celgene is committed to patient safety, and its products have improved and extended the lives of many thousands of cancer patients

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#Pharma Drug Repurposing: How Drugs Spread from Disease to Disease

#Pharma Drug Repurposing: How Drugs Spread from Disease to Disease | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While drug development is typically thought of as the disease-centric process of finding a drug that can treat a disease, much effort goes in the reverse, drug-centric direction of finding a disease that can be treated by a drug. The diseases for which a drug is intended can change over the course of its development and post-marketing. During pharmaceutical development, new diseases can be selected or dropped at every stage of the pipeline on the basis of pre-clinical and clinical results. When a drug starts to show signs of success with a particular disease, additional diseases are sought to broaden the drug’s therapeutic and commercial appeal. Once a drug has been approved by regulatory agencies, its use may not be restricted to the diseases for which it was approved, as medical practitioners may prescribe it off-label. Indeed, a drug’s efficacy against certain diseases may only become fully apparent once it is consumed by a large number of patients or made widely available for scientific experimentation. New findings about a drug’s efficacy can prompt the original drug developer to seek supplemental indication approvals or pursue life-cycle management strategies such as combining the drug with other new or existing drugs.

This is not to say that drugs are created ex nihilo. They are generally designed with an intent rooted in biological rationale, such as to inhibit a disease-causing gene. However, the interconnected nature of human biology and of pathological mechanisms, the steady advance in our understanding of diseases and the potential lack of target selectivity means that drugs designed for a specific purpose can end up having different or additional applications. Once a drug is created it can fail with diseases for which it was designed and succeed with unanticipated diseases. Thus, drugs hold an intrinsic value based not only on their proven therapeutic effect but also on their therapeutic potential, both suspected and unsuspected.

Because the process of pharmaceutical drug discovery is long and uncertain, a central part of a drug’s suspected therapeutic potential is the drug’s prospects to treat multiple diseases. Challenges to a drug’s development may come from faster-advancing competing drugs that can become standard of care and discourage further work on other drugs. They may also come from business vagaries such as department closures in pharmaceutical companies that lead to re-alignment of internal drug portfolios. Thus, having multiple potential applications increases the likelihood that a drug will be able to navigate the development process.

The unsuspected therapeutic potential of a drug is illustrated most clearly by the field of drug repurposing. Drug repurposing has drawn attention in part due to the commercial interest of pharmaceutical companies possessing an abundance of safe drugs that have failed to show sufficient efficacy in any disease. The “poster child” of drug repurposing success is that of a safe but abandoned drug that is discovered to be efficacious with a previously unsuspected disease. While drug repurposing focuses on late-stage and post-marketed drugs, the search for unsuspected diseases for existing drugs can be undertaken at any point in a drug’s history.

Pharma Guy's insight:

A good example is Botox. Read "Botox: Pharma's Answer to Duct Tape"; http://bit.ly/botoxducktape 

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Number of Medical Science Liaisons Expected to Increase by 36% - They Go Where Reps Cannot

Number of Medical Science Liaisons Expected to Increase by 36% - They Go Where Reps Cannot | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Medical Science Liaisons (MSLs) are a crucial part of global, U.S. and country-level medical affairs teams. MSLs have multifaceted roles including gathering competitive intelligence, facilitating clinical studies and coordinating investigator-initiated trials (IITs), according to primary intelligence provider Cutting Edge Information. The growing importance of this role moving forward is highlighted by the fact that 92 percent of medical affairs teams at Top 10 companies oversee MSL activities.

 

With patients now visiting their healthcare providers after doing research online, physicians are increasingly looking to MSLs to provide current and useful information for their practices. MSLs have an important role in working with healthcare providers to ensure that they are prepared to have these discussions with patients. In addition to asking specifics about products, patients are asking questions about the entire disease state and treatment pathway.

 

"MSL's roles extend beyond building relationships with thought leaders and answering unsolicited off-label questions," said Natalie DeMasi, senior analyst at Cutting Edge Information. "They are invaluable to life science companies and the healthcare providers they serve."

Pharma Guy's insight:

MSLs - who are healthcare professionals - probably have access to physicians where access to traditional pharma reps is denied. Obviously, there are not enought of them to replace sales reps, but their role viz-a-viz off-label promotion is bound to increase due to recent court decisions. For more on that, read  "Brave New World of Off-Label Marketing"; http://bit.ly/pmn150203p

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FDA May Soon Be Replaced by Judicial Off-Label Activism

FDA May Soon Be Replaced by Judicial Off-Label Activism | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.

 

The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.

 

Under the settlement, Amarin would have to submit proposed marketing materials to the agency, which could then object if it felt the information was untrue or misleading. If the two parties could not agree, a federal judge would sort it out.

 

Leaving such decisions to a judge, not the F.D.A., concerned Dr. Joshua M. Sharfstein, a former principal deputy commissioner at the F.D.A. who is now an associate dean at the Johns Hopkins Bloomberg School of Public Health.

 

“The courts are at the precipice of taking over a fundamental F.D.A. function of calling balls and strikes in the drug market about what’s truthful and not misleading,” Dr. Sharfstein said.

 

Alan Bennett, a lawyer who represents the Medical Information Working Group, a coalition of drug and device companies that want the F.D.A. to expand their ability to talk about their products, said he agreed that the F.D.A., not the judiciary, was best able to evaluate information about drugs.

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Pharma to FDA: "We're Here to Help" You Vet Off-Label Information

Pharma to FDA: "We're Here to Help" You Vet Off-Label Information | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Should an independent entity review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors?

 

Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.

 

This month, a think tank at Duke University called (http://sco.lt/5mZaL3) for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.

 

Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.

 

“There’s a lot of accurate and scientifically robust information that can be shared,” said Peter Pitts, a former FDA official who now heads the Center for Medicine in the Public Interest and is one of the authors of the proposal. “But the FDA can’t be expected to review everything itself.”

 

That’s true. The agency does have limited resources. But the real issue is whether an independent body would, ultimately, undermine FDA authority and serve as a marketing tool as much as anything else.

 

Industry critics have long worried companies are looking for ways to distribute promotional fluff. And such concerns divided the working group at the Duke-Margolis Center for Health Policy, which hosted a conference two weeks ago where the paper was issued and discussed (watch session one and two).

 

“I think this proposal is asking the wrong question,” said Dr. Joshua Sharfstein, a former deputy FDA commissioner and an associate dean at the Johns Hopkins Bloomberg School of Public Health, who did not help write the proposal.

 

“I fear this is all about asking how we can allow companies to promote as much as possible,” he said. “Instead, we should be asking: How can we create the correct incentives so that good research is done and we get the best information to distribute?”

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Strike 2! FDA Avoids Another Off-Label Court Fight by Capitulating to Pacira's Demands

Strike 2! FDA Avoids Another Off-Label Court Fight by Capitulating to Pacira's Demands | Pharmaguy's Insights Into Drug Industry News | Scoop.it

STRIKE TWO! for the FDA...


Last week the US Food and Drug Administration (FDA) lost another tooth, and the pharmaceutical industry won another battle in its ongoing effort to roll back safety regulations that impinge on its profit margin.


The regulatory agency capitulated to drug company Pacira Pharmaceuticals’ demand that it revoke restrictions it had placed on Pacira’s marketing of its pain medication Exparel. Exparel had been tested and approved for the treatment of pain following bunion and hemorrhoid removal by applying it to the site of the surgery. Pacira had been marketing Exparel to physicians as an effective pain treatment for a wide array of surgeries.


In September, the FDA issued a formal warning to Pacira to stop such “off-label” marketing. The drug company, based in Parsippany, New Jersey, responded by filing a lawsuit claiming the FDA’s regulation violated its First Amendment right. Pacira argued that its off-label marketing was protected free speech as long as the information it provided was truthful. Giant drug companies Pfizer, Johnson & Johnson, GlaxoSmithKline, Novartis and others filed amicus curiae briefs for the case, making clear that that the pharmaceutical industry as a whole was watching the Exparel case closely.

Pharma Guy's insight:

Meanwhile, reported on Pharmalot: "Amid free speech battle, FDA yanks Pacira letter" - http://bit.ly/1hR3YHK 


It’s not every day that the Food and Drug Administration removes a warning letter from its web site. But the agency did just that recently when it pulled down a missive that was originally sent last year to Pacira Pharmaceuticals. And the removal comes just as a closely watched legal battle – which, in part, turns on First Amendment rights – heats up between the drug maker and the agency.


Now we know why the letter was yanked.


Also read:

FDA Prepares for Further Off-Label Promotion Free Speech Court Fights; http://sco.lt/8LbChl 

Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?"; http://sco.lt/8n81L7 


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FDA Prepares for Further Off-Label Promotion Free Speech Court Fights

FDA Prepares for Further Off-Label Promotion Free Speech Court Fights | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After months of anticipation, pharmaceutical marketers and the Washington legal community continue to wait for FDA to address options for updating its policies governing sponsor communications involving unapproved drug uses. FDA officials said more than a year ago that they would hold a public meeting to discuss agency policy related to industry “speech” on regulated products. That event now appears on hold until the agency issues further advisories on these issues. A draft guidance on communication of off-label information evidently is in development, a document that has become more critical – and more complicated – in the wake of court rulings challenging FDA restrictions on company communications as unconstitutional.


Additional guidance also is in the works to address the related issue of disseminating health care economic information, a key area of expanded communications sought by pharma companies. The 21st Century Cures legislation approved by the House includes language authorizing greater flexibility for marketers to provide comparative effectiveness data to payers and formulary committees. FDA clarification of this issue is important, though, especially as prospects dim for fast Congressional action on this and related topics.


Pressure has mounted for FDA to address these concerns following rulings by the Supreme Court and other federal courts that support First Amendment protection for pharmaceutical marketers to present truthful and non-misleading information on approved therapies. In fact, the courts have indicated that a government agency needs highly compelling reasons to restrict commercial speech, and that more open discussion of treatment options involving biomedical therapies could be highly beneficial and save lives.

Pharma Guy's insight:

Meanwhile, reported on Pharmalot: "Amid free speech battle, FDA yanks Pacira letter" - http://bit.ly/1hR3YHK 


It’s not every day that the Food and Drug Administration removes a warning letter from its web site. But the agency did just that recently when it pulled down a missive that was originally sent last year to Pacira Pharmaceuticals. And the removal comes just as a closely watched legal battle – which, in part, turns on First Amendment rights – heats up between the drug maker and the agency.


Indeed, as unusual as it is for the FDA to remove a letter, what makes this still more interesting is that it occurs amid a lawsuit Pacira filed recently accusing the FDA of overstepping its authority to thwart inappropriate marketing.


Drug makers, you may recall, must prove their medicines work to treat a specific disease before marketing them for that purpose. As a result, the agency has the right to prevent them from promoting drugs for unapproved uses.  But the pharmaceutical industry increasingly complains the FDA unfairly squelches free speech in the name of protecting public health. Pacira is only the latest to vent.


Perhaps not coincidentally, the Pacira lawsuit was filed shortly after another drug maker won a preliminary ruling in a First Amendment case. Last August, a federal judge decided Amarin could promote the benefits of a prescription pill, so long as the info given doctors is not false or misleading.


The issue has been widely debated after a federal appeals court in 2012 overturned a criminal conviction of a Jazz Pharmaceutical sales rep for promoting off-label uses. The court ruled his speech was protected, since the information that was conveyed to doctors was truthful and not misleading.

As for the Pacira warning letter, which was issued on Sept. 22, 2014, the FDA scolded the drug maker for allegedly promoting its Exparel painkiller for unapproved uses and overstating efficacy. The medicine is used following surgery.


The removal surprised FDA watchers.


“It is unusual,” said Patti Zettler, a former FDA associate chief counsel who is now a Georgia State University College of Law professor. But she he noted the FDA is free to remove warning letters. An agency spokeswoman declined comment, citing pending litigation. Perhaps we will learn more next week when the FDA is due to file court papers in its fight with Pacira.


But what does the letter say and why might it be important?

We still have a copy, which you can read here, and it goes to the heart of this simmering dispute.


MORE ON THIS: As part of a lawsuit settlement, the FDA rescinded the September 2014 warning letter that accused Pacira of allegedly promoting the drug for unapproved uses and overstating its effectiveness. The agency had actually removed the letter from its web site several weeks ago as negotiations were under way, a move that FDA watchers said at the time was highly unusual.


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