Pharmaguy's Insights Into Drug Industry News
184.7K views | +1 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

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.”

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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.


more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Amarin Wins Off-Label Case Against FDA; Vows to Promote Viscera Off Label "ASAP"

A U.S. District Court on Friday made a preliminary ruling in favor of Amarin Corp. in its lawsuit against the U.S. Food and Drug Administration, saying the Irish drug maker has the right to promote information about off-label uses for its prescription fish-oil pill.

The court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of Vascepa that aren't covered by the drug's FDA-approved labeling—as long as the information is true and not misleading.

A FDA representative declined to comment, saying the agency "does not comment on possible, pending or ongoing litigation." An appeal of the ruling can be filed within 60 days, Amarin said in a news release.


Amarin had filed its suit in May in a move that was expected to have broad ramifications for the way the pharmaceutical industry markets medicines and interacts with physicians.


Shares of Amarin surged 15% to $2.35 following the ruling.

Amarin wanted to provide doctors with clinical trial data that didn't directly pertain to the approved uses of its Vascepa prescription fish-oil pill. The FDA had endorsed the drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.


But Amarin wanted to market the pill to people with slightly lower levels of triglycerides who were already taking statins, a cholesterol drug. Amarin also wanted to reference data from an FDA-approved study that showed Vascepa's potential to reduce the risk of cardiovascular disease, according to the suit. The FDA rejected Amarin's bid.


Amarin said it can now use efficacy data from the clinical trial and other relevant study results. The company said it plans to begin promotional activities as soon as possible.


The question over where drug makers should be allowed to distribute information about unapproved uses of their medicines has been widely debated after a federal appeals court overturned the criminal conviction of a sales rep for promoting so-called off-label uses of a drug three years ago. The court ruled his actions constituted protected speech because the information was truthful and not misleading.


Since then, the pharmaceutical industry has been lobbying the FDA to revise its guidelines, because the decision only applied to three states.


Pharma Guy's insight:

Hmmm... FDA has 60 days to appeal the decision. I guess Amarin can marshall its sales force to do a lot of off-label promotion to physicians during that time.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Paid Amarin KOLs Do Not Have "Free Speech," Says Forbes Opinion Piece

Free speech, in the corporate world in general and the pharmaceutical industry in particular, means something quite different from what our country’s founding fathers might have imagined. In this world, “free” speech is paid for, often handsomely, and the companies and people who pay out the money maintain exquisite control over that “free” speech.


At the same time Amarin announced that it had filed its lawsuit it sent a confidential letter (reprinted at the bottom of this story) to physicians who serve on its speakers’ bureau and who are paid to speak to other physicians on behalf of the company. Every company has a similar program for its drugs.


The Amarin letter makes clear that physicians who speak on behalf of Amarin do not have free speech. They must adhere to the strict guidelines of the company. Many of these guidelines are in place to make sure that the talks fall within what the FDA permits the company to say, but many of the talking points represent the company’s best efforts to spin the available data and literature. There is no attempt to present a balanced position representing the views of the company’s critics, for instance.


Amarin’s notion of the first amendment protects and enhances the free speech of corporations but severely limits the speech of individual people.


Pharma Guy's insight:


You can find the complete text of Amarin's "secret letter" to their KOLs here: http://onforb.es/1ASeNx2 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Amarin Takes FDA to Court Fishing for Right to Promote Off-Label Use of Vascepa

Amarin Takes FDA to Court Fishing for Right to Promote Off-Label Use of Vascepa | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A small drug maker called Amarin has filed a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment.


Amarin wants to be able to provide doctors with clinical trial data that does not directly pertain to the approved uses of its Vascepa prescription fish-oil pill, the lawsuit states. The FDA endorsed drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.


Specifically, Amarin seeks to provide doctors with data about the effectiveness of its drug to treat people with slightly lower triglyceride levels. But last month, the FDA rejected an Amarin bid to market its pill to that patient population and denied its plan to add the data to the Vascepa product labeling.


Yet the drug maker believes it has a constitutional right to distribute the information, even though such a move would be considered to be off-label promotion by the FDA. And so, Amarin is asking a federal court in New York to “declare [that] it may engage in its proposed speech about Vascepa.”


Even though doctors are free to prescribe medicines for any use, the FDA has long argued that off-label promotion may be evidence that a drug maker intended or attempted to sell misbranded medicines. The agency also maintains that off-label promotion effectively skirts the drug approval process.


One consumer advocate agrees. “If companies can go directly to physicians with studies they believe support other uses, they would be no motivation to seek FDA approval for those purposes,” says Michael Carome, the director of Public Citizen Health Research Group.


In its lawsuit, Amarin counters that FDA regulations are not only onerous, but prevent doctors from obtaining information from the “most knowledgeable sources – the drug manufacturers.” The lawsuit was joined by four physicians who, the suit says, prescribe Vascepa off-label to people with varying levels of triglycerides.

Pharma Guy's insight:


Cable-TV star Rick Harrison (host of the show Pawn Stars) is a celebrity spokesperson for Vascepa. Here's his official announcement made via his @GoldSilverPawn Twitter account, which has over 155,000 followers: 

"Excited to share my story of lowering my very high #triglycerides through the new Lower My Trigs campaign: http://bit.ly/1uXxUSP #spon"


If Amarin wins this case, Ricky can use fewer characters in his tweets by shortening "very high #triglycerides" to just "high #triglycerides".

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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.

more...
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.

Scooped by Pharma Guy
Scoop.it!

Advice from an Expert: If FDA Won't Budge, Take It to the Judge!

Advice from an Expert: If FDA Won't Budge, Take It to the Judge! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A judge's ruling allowing one drugmaker to engage in off-label promotion upends longstanding taboos about what is permissible to market beyond the FDA-approved label, but companies still need to proceed carefully if they want to exploit the legal opening to pursue similar claims.  


The ruling in question permits Amarin to legally share truthful, scientific data that demonstrates that its prescription fish-oil drug, Vascepa, can lower triglyceride levels in patients with less severe hypertriglyceridemia.

 

The FDA approved Vascepa in 2013 as a treatment for patients with severely high triglyceride levels, a condition that affects about 4 million people in the US. Amarin had sought out a broader indication that would have allowed it to market Vascepa to a patient population that is ten times bigger, a move that would have differentiated the drug from competitors and most likely boosted sales.   


When the FDA declined to approve the drug as a therapy for patients with elevated triglyceride levels, a less severe form of the condition, Amarin sued, alleging that the agency violated its First Amendment rights and contending that the information it wants to provide to physicians is mostly derived from an FDA-approved study and from FDA materials.


“At this stage, the court's judgment is to err on the side of caution, meaning in favor of giving doctors more, not less, information,” the judge wrote in his decision.  


Still, the closely watched ruling, while a setback for FDA and a win for Amarin, doesn't give drugmakers free rein to communicate any off-label information they want to physicians or patients. 


What it does do is create a legal pathway that other pharma companies can mimic by first ensuring they have collected truthful scientific data, then seeking permission from the FDA to communicate that data and finally taking their case to the US Court of Appeals Second Circuit as the final option. 


“The procedure is out there,” said Jim Beck, a lawyer with Reed Smith.

Pharma Guy's insight:

This is terrible advice! What's the next step? Will the court force the FDA to approve drugs based on what IT considers "truthful" evidence vs. scientific evidence?

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA to Amarin: Chill Out, Dude! Don't Sue Us! You Have Free Speech.

Last month, a small drug maker called Amarin caused a stir by filing a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment.


Now, in an unusual move that appears designed to blunt the impact of the lawsuit, the FDA has written a letter to Amarin saying the types of materials the drug maker would like to distribute to doctors actually would not be a problem. And the FDA suggests that Amarin might have known this if the drug maker had discussed the issue before filing its lawsuit.


As it turns out, the FDA says that Amarin never approached the agency about the issue.In her letter, FDA official Janet Woodcock makes a point of writing that Amarin “did not ask for our views before filing” its lawsuit “as other pharmaceutical companies sometimes do.” A spokesman for Amarin says  the drug maker would not comment.


Moreover, Woodcock also reiterated FDA plans to release a so-called industry guidance for governing the dissemination of off-label information. In effect, the letter amounted to a pre-emptive move that might slow the progress of the lawsuit, according to regulatory experts.


Adds Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry: “Amarin got some bad regulatory advice. The FDA has loudly signaled that it is going to act with increased regulatory discretion on off-label communications. This was either missed or ignored by Amarin.


“… A meeting with the agency would have addressed their concerns. [As for the FDA], “exercising regulatory discretion is a smart move as it takes the matter out of the hands of a judge. A free speech ruling would make things much more difficult for the agency. The FDA opted for strategic retreat rather than face a potential sledgehammer legal decision.”

Pharma Guy's insight:


Also, FDA said in a footnote to the letter: "FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, non-misleading, and non-promotional scientific or medical information that is responsive

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

As Amarin Sues FDA Over Off-Label "Free Speech," #Pharma Scientists Scoff

As Amarin Sues FDA Over Off-Label "Free Speech," #Pharma Scientists Scoff | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Won't this be interesting to watch? I'm no constitutional lawyer, but the FDA seems to have lost a few decisions in this area already, and I'm betting that they'll lose this one, too. If they do, then we'll have a pretty lively time of it, sorting out what can and can't be said, but the "can" side will be on top.


Selected comments:


Free-speech and drug promotion are different things. One is to allow opinions, the other to utilize FDA verified facts to sell products. Its hard to feel good about being in Pharma when there is such blatant greed..[and] for GD fish oil!


Wouldn't the old yelling fire in a crowded movie house argument apply here? Basically, speech can be limited by statute in the name of public safety.


Yes, I would have to agree. ... most other Western countries have more limits on free speech and seem to have a lot less of the BS that is continually a source of frustration in the US public sphere. Basically, other free and healthy democratic countries have found ways to put some common-sense limits on free speech without collapsing into police states and communism.


Why bother with those expensive double-blind placebo-controlled trials? Run two of them (PhIII) in a small indication (preferably a lethal one with no SOC). After it's approved, run dodgy open-label studies in much larger indications. Then use your "free-speech rights" to inform the public about this miraculous off-label use. Sounds like the new (maybe only) profitable business plan for Pharma.


Pharma Guy's insight:


This is a sampling of comments to an In the Pipeline blog post that reported about the Amarin suit against the FDA (for background, see here: http://sco.lt/90Sefp 


Most readers of and commenters to this blog - I assume - are scientists working within the pharma industry. Some of the comments are more interesting than the post!

more...
No comment yet.