Pharmaguy's Insights Into Drug Industry News
187.2K views | +13 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!

Grading FDA Commissioner Gottlieb & PhRMA's "Go Boldly" Campaign

Grading FDA Commissioner Gottlieb & PhRMA's "Go Boldly" Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Food and Drug Administration Commissioner Scott Gottlieb earned high marks from [a STAT Plus] survey respondents.

 

One respondent explained why Gottlieb deserved an F: “I see no vision or mission except keep Trump happy. Good luck.”

 

But the vast majority sang his praises.

 

  • “He’s shown an independence from the pharmaceutical industry that I was not expecting and seems dedicated to balancing safety with efficiency.”

 

  • “He’s a moderate! Speeding things along but not foolishly.”

 

  • “Dr. Gottlieb seems interested in getting other agencies to do their jobs. He seems interested in improving competition and drug shortage to the best of FDA’s ability — although these problems are pharma’s to fix — not FDA’s.”

 

Further Reading:

  • “Dr. Scott Gottlieb’s Plan to ‘Get Things Done’ at #FDA is Approved by #Pharma”; http://sco.lt/7iW5TN
  • “Does Pharma Really Want to Abandon the ‘Gold Standard’ of the FDA Approval Process?”; http://sco.lt/74r19d
  • “Pharma Scientists Concerned About Gottlieb’s Industry Ties”; http://sco.lt/8jOq0n

 

The trade group PhRMA has tried to reframe the drug price debate with its “Go Boldly” campaign, paid for by a hike in membership fees. In decidedly lukewarm reviews, more than a third of respondents gave that initiative a modest 2 on a scale of 1 to 5 (with 5 being a rave). Roughly a quarter split between 1 (the worst) and 3 (meh), though one respondent noted that “featuring industry scientists was a great choice, from a PR standpoint.”

 

Among the other comments:

 

  • “All the ‘bold’ in the world doesn’t matter when people can’t afford treatments.”

 

  • “The ads are good. … People like pharma for the drugs it produces. Its R&D is not what galls people. It’s pricing and business practices.”

 

  • “There’s a ‘Go Boldly’ campaign?”

 

Further Reading:

  • “He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent”; http://sco.lt/5BIFgP
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Makes Side-Effect Database Searchable

FDA Makes Side-Effect Database Searchable | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If you had a bad reaction after taking a medicine, there’s now an easy way to find out whether others experienced the same.

The U.S. Food and Drug Administration improved its online database of reports about side effects filed by patients and doctors, making it easily searchable by product, patient age, type of side effect or year it occurred.

It means that, for the first time, the public will have access to data it can make sense of. Previously, inquiring minds needed to know a little about coding to figure out the FDA’s adverse-reaction database. And even then, they had to file a Freedom of Information request with the government to get the actual reports and check the information’s accuracy.

The FDA said it hopes that the increased transparency will spur patients and doctors to submit more detailed and complete reports. Many patients don’t even know they can submit adverse-event reports to the agency.

 

Further Reading:

  • "Institute for Safe Medicines Practices Calls for a Full-scale Modernization of FDA’s Adverse Event Reporting System"; http://sco.lt/7AC2N7
  • “So Far, FDA’s Sentinel Drug Safety Monitoring Initiative Has Not Delivered as Hoped”; http://sco.lt/7P4T3Z 
  • “OpEd: FDA's Antiquated Drug Safety Program is ‘Obscene’"; http://sco.lt/7O6qVV 
  • “Another Aspect of Patient Power: Making It Easier to Report Adverse Events!”; http://sco.lt/6bgAZl 
  • “More Than 1 Million Adverse Event Reports Were Sent to FDA in 2015 – Only the Tip of the Iceberg”; http://sco.lt/6gfruL 
  • “Deregulation and Budget Cuts Likely to Lead to Increased Adverse Event Reporting”; http://sco.lt/5ZuET3 
  • “FDA's Dependence on User Fees & ‘Institutional Corruption’ Blamed for Dramatic Increase in Drug Adverse Events and Deaths”; http://sco.lt/8pXZD7 
  • “#FDA Blames Computer Glitch for Hundreds of Errors Found in Essure Adverse Event Reports”; http://sco.lt/6aCd0b 
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Funny, Witty, Snarky Pharmaguy Memes About Pharma

The original, pre-internet definition of a meme is, “an element of a culture on system of behavior that may be considered to be passed from one individual to another by non-genetic means, especially imitation”.

Today, the “element of culture” is often an image or photo that has spread through social media or texting and which has been modified to include overlaid text. At least, that is how my son defines meme.

Over the years I have created numerous memes that I hope will be copied and passed on from one pharmaceutical marketer to another. This PowerPoint presentation includes many of my favorite memes and some insights on why I created them. Most of these memes have to be viewed in context of the news and events that inspired them. So for each one, I provide links back to the original social media post in which they appeared. Hopefully that will provide the necessary context.

Enjoy and feel free to spread them through your social media channels!

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

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.

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

Biopharma execs give Scott Gottlieb’s nomination for FDA commish (almost) a standing O in Endpoints poll

Biopharma execs give Scott Gottlieb’s nomination for FDA commish (almost) a standing O in Endpoints poll | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A big majority of biopharma executives overall are clearly enthusiastic about President Trump’s decision to nominate Scott Gottlieb as the next FDA commissioner.

In our snap poll over the weekend Gottlieb picked up 87% support among the 580 qualified subscribers who voted on the decision, with 504 approving the choice against 76 who largely hated it.

 

[Public Citizen, however, said “[Gottlieb] Has Extensive Industry Ties and Dangerous Deregulatory Ideas”.]

 

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

Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations

Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen, the Natural Resources Defense Council (NRDC) and the Communications Workers of America sued the Trump administration today to block an executive order signed by President Donald Trump on Jan. 30 that directs federal agencies to repeal two federal regulations for every new rule they issue.

The plaintiffs are asking the court to issue a declaration that the order cannot be lawfully implemented and bar the agencies from implementing the order.

The order requires new rules to have a net cost of $0 this fiscal year, without taking into account the value of the benefits of public protections.

The suit, filed in the U.S. District Court for the District of Columbia, names as defendants the president, the acting director of the Office of Management and Budget (OMB) and the current or acting secretaries and directors of more than a dozen executive departments and agencies. The complaint alleges that the agencies cannot lawfully comply with the president’s order because doing so would violate the statutes under which the agencies operate and the Administrative Procedure Act.

"No one thinking sensibly about how to set rules for health, safety, the environment and the economy would ever adopt the Trump Executive Order approach – unless their only goal was to confer enormous benefits on big business,” Public Citizen President Robert Weissman said. “If implemented, the order would result in lasting damage to our government’s ability to save lives, protect our environment, police Wall Street, keep consumers safe and fight discrimination. By irrationally directing agencies to consider costs but not benefits of new rules, it would fundamentally change our government’s role from one of protecting the public to protecting corporate profits.”

Pharma Guy's insight:

Further Reading: “FDA Regulation Cutting Will Impact Drug Approvals Too”; http://sco.lt/6XmjR3

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

2016 Sees a Slight Uptick in FDA Enforcement Actions

2016 Sees a Slight Uptick in FDA Enforcement Actions | Pharmaguy's Insights Into Drug Industry News | Scoop.it

UPDATED 15 December 2016: A few days ago, I reported that FDA continues to issue fewer and fewer warning and untitled letters. When I wrote that (8 December 2016) FDA had issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015.

 

This week on 12 and 13 December, FDA issued 4 new letters - 2 warning letters and 2 untitled letters - to bring the total to 9 letters for 2016. As the revised chart on the left shows, this equals the number of total letters FDA sent last year but this year, to date, FDA issued one more warning letter than it did last year. So, this could be considered a "slight uptick" in enforcement actions since warning letters are more serious than untitled letters, although the additional warning letter involved the promotion of a surgical irrigation solution promoted by United-Guardian via email to healthcare professionals.

 

Perhaps FDA is clearing its backlog and approving letters to be sent before the Trump regime takes over. That is, if Trump has his way and Silicon Valley investor Jim O’Neill becomes the new FDA Commissioner.

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

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.

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

Novo Nordisk Thanks #FDA for Forcing It to Prove Victoza Can Decrease CV Events

Novo Nordisk Thanks #FDA for Forcing It to Prove Victoza Can Decrease CV Events | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Researchers announced that Victoza, a diabetes drug sold by Danish drug giant Novo Nordisk , prevents heart attacks, strokes and cardiovascular deaths.

 

It is only the second diabetes drug ever to do so. The first, Jardiance, a pill sold by Eli Lilly and Boehringer Ingelheim , presented its positive results just last year. Researchers say that the new results could change the way that doctors treat diabetes, shifting the treatments doctors reach for after metformin, the tried-and-true first-line drug, which is generic.

 

“There’s a building momentum that maybe we do need to rethink the way diabetes is cared for in America,” says John Buse, the University of North Carolina, Chapel Hill researcher who led the study, which was funded by Novo Nordisk.

 

And doctors and Novo Nordisk itself give credit to the new diabetes data to a surprising source: Tougher regulations for diabetes drugs from the Food and Drug Administration, which many in industry had previously decried, saying it was keeping new drugs from the market and hurting patients.

 

“I can almost guarantee you that these trials would not have been done if it had not been for the FDA regulations,” says Buse, who has been a consultant to many companies for years. “Before the guidance I was constantly pushing on companies to do these trials.”

 

That fact – that companies and patients are likely to benefit from the FDA’s toughness – goes against one of the common narratives in the drug industry and among the FDA’s critics: that high regulations slow patients’ access. In some cases, its clear, they also create a bar for industry to leap over, and deliver billions of dollars in spoils to companies that actually manage to help patients, not just blood test results.

 

The Victoza result is exactly the kind of marketing claim that makes a drug company salivate: Novo Nordisk can now tell patients and their insurers that the alternative to its drug is an earlier death.

Pharma Guy's insight:

The research showed that 13% of patients on Victoza had a heart attack, stroke, or death, compared to 14.9% on placebo, a 13% decrease in risk. Reductions in cardiovascular death (22%) and death from any cause (15%) were also statistically significant.

 

Now, perhaps, Novo won't have to bribe so many physicians or promote the drug for weight loss. For more on that, read "Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians"; http://sco.lt/9141vV "Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs"; http://sco.lt/84lZtR

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

Gallery of FDA Studies of DTC Advertising: Is All This "Research" Necessary?

Gallery of FDA Studies of DTC Advertising: Is All This "Research" Necessary? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This is my personal (partial) list of FDA studies of direct-to-consumer (DTC) advertising that I have commented on over the years in Pharma Marketing Blog and Pharma Marketing News. Enjoy!

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

FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels

FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels | Pharmaguy's Insights Into Drug Industry News | Scoop.it

FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.

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

Thank You Martin Shkreli for Goosing FDA to Act More Expeditiously to Approve Generics!

Thank You Martin Shkreli for Goosing FDA to Act More Expeditiously to Approve Generics! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a significant move, the Food and Drug Administration late last week made a policy change that may prevent companies from pulling a Martin Shkreli.

The agency plans to expedite reviews of applications for generic drugs where only one treatment is currently sold. The shift was prompted by public outrage that erupted last fall when Turing Pharmaceuticals, which Shkreli ran before he was indicted for securities fraud, bought a life-saving drug called Daraprim and promptly jacked up the price by 5,000 percent, from $13.50 a tablet to $750.

“We identified a gap and were able to identify a path forward,” an FDA spokeswoman wrote us. “The change being made (allows the agency) to capture circumstances when the only approved product on the market is a generic drug.”

Even though Turing does not hold a patent on the medicine, used to treat a rare parasitic infection known as toxoplasmosis, the company was able to increase the price as it did because there was no generic competition. The drug maker runs a closed distribution system, and as a result, Turing has a monopoly on Daraprim. Even if a generic drug maker wanted to enter what was suddenly a more lucrative market, any company would encounter a delay winning FDA approval since the agency faces a huge backlog of applications.

“This is a big deal,” said John Rother, who heads the National Coalition on Healthcare, a collection of insurers, employers, and unions, among others, that have objected to rising prices. “This should provide a faster way to inject competition in the marketplace, so that the price gougers can’t get away with what they’re doing.”

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!

EpiPen Failures on the Rise Just Like Its Price

EpiPen Failures on the Rise Just Like Its Price | Pharmaguy's Insights Into Drug Industry News | Scoop.it

EpiPens, which contain the hormone epinephrine (also known as adrenaline), are used to stave off allergic reactions that can in some cases kill. Failure of EpiPens to deploy correctly have been cited in seven deaths this year through mid-September, according to reports by patients and physicians made to the U.S. Food and Drug Administration and obtained by Bloomberg News. The FDA received a total of 228 reports of EpiPen or EpiPen Jr. failures during the same time period, according to documents made available as a result of a Freedom of Information Act request. In addition to the deaths, 35 people were hospitalized, according to the reports.

 

Until now, the medical device has been the subject of controversy for a different reason. EpiPen is sold by Mylan NV, a drugmaker legally based in the Netherlands but run from Pennsylvania, that was under fire last year for significantly raising the price of the allergy shot, from about $50 for a single pen to more than $600 for a two-pack. Congress held hearings, government agencies began inquiries, and rival Sanofi sued. The Paris-based competitor claimed Mylan sought “to preserve the monopoly position of their $1 billion crown jewel” by engaging in anti-competitive conduct. Mylan has denied any wrongdoing.

 

EpiPen and EpiPen Jr. failures, meanwhile, resulted in a recall of some units in March by the company that makes the device for Mylan, Pfizer Inc.’s Meridian Medical Technologies. Mylan, which sells the drug-device combo using Meridian’s “pens,” called the defect “extremely rare” (read “A Pfizer Company that Makes EpiPen Devices Failed to Investigate Patient Deaths Says FDA”; http://sco.lt/8L7r8b).

 

Reports submitted by users to the FDA, however, show broadening accounts of malfunctions dating as far back as 2014.

 

More About EpiPen:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Patient Advocates Should Have Fought For Affordable Duchenne Drug as More Insurers Deny Coverage

Patient Advocates Should Have Fought For Affordable Duchenne Drug as More Insurers Deny Coverage | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The story of Exondys 51 raises complex and emotionally charged questions about what happens when the F.D.A. approves an expensive drug based on a lower bar of proof. In practice, health insurers have taken over as gatekeeper in determining who will get the drug.

 

Disputes like the one over the Duchenne drug are likely to become more commonplace in the coming months. A federal law, passed last year, directs the agency to remove barriers to approving drugs and medical devices, and its new commissioner, Dr. Scott Gottlieb, has called on the F.D.A. to be more lenient, especially when it comes to rare pediatric diseases.

 

While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases.

 

The agency’s approval of Exondys 51, though, prompted a rebellion among some insurers, who are refusing to play along and saying they are concerned about the cumulative impact of such breathtakingly expensive drugs on health care costs. Anthem, one of the nation’s largest insurers, calls Exondys 51 “investigational” because the F.D.A. reserved the right to withdraw it from the market if future clinical trials fail to show it works.

 

Another insurer, Premera Blue Cross, went so far as to tie coverage to an invasive procedure — a muscle biopsy — but then rescinded the requirement.

 

“I’m reading a lot of denial letters,” said Christine McSherry, who until recently served as executive director of the Jett Foundation, an advocacy group that guides families through the insurance appeal process. Her insurer, Blue Cross Blue Shield of Massachusetts, is covering the drug for her son, Jett, through next April. “It’s very disheartening to have worked that hard, and to have sacrificed that much, and to now have to battle the insurance companies.”

 

The drug’s high cost is driving the resistance. While the drug manufacturer, Sarepta, has said Exondys 51 costs about $300,000 a year per child, the price, based on a child’s weight, can be much higher. For the dozen boys in the main clinical trial, the average list price would be more than double Sarepta’s quote — $750,000 each, according to an analysis by the drug benefit firm Prime Therapeutics.

 

“I think a lot of the advocates in this space maybe thought that getting a drug on the market was the goal of their advocacy,” said Dr. Aaron S. Kesselheim, an associate professor of medicine at Harvard University who voted against the drug’s approval as part of an F.D.A. advisory committee. “The goal of the advocacy should have been getting a product on the market, and making sure that it’s available at a reasonable cost.”

 

Further Reading:

  • “2nd Largest Health Insurer – Anthem – Won’t Pay for FDA-Approved Duchenne Drug”; http://sco.lt/6hlYP3
  • “FDA’s Approval of Exondys 51 for DMD Was Primarily Based on Money, Not Efficacy”; http://sco.lt/62xNoH
Pharma Guy's insight:

This article also points out that this may be a trend for expensive drugs that are approved for rare diseases: "While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases."

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

It's Official. Califf Abandons Pharma & Sides With Silicon Valley to Solve Inequities in Healthcare

It's Official. Califf Abandons Pharma & Sides With Silicon Valley to Solve Inequities in Healthcare | Pharmaguy's Insights Into Drug Industry News | Scoop.it

My hope is that Silicon Valley and entrepreneurs nationwide will collaborate on building an environment capable of linking the more than 300 million people in the U.S. to information that helps them live healthy, productive lives. Within this broad mission, I’m particularly focused on bridging a growing divide that has led to unprecedented health disparities as functions of income, education, race, and geography. But as increasingly ubiquitous smartphones and other electronic devices allow more and more people to access amazing sources of information and knowledge, we have the essential means to reverse these trends.


Both giant information companies and our country’s universities—particularly those with large health systems—have critical roles to play in ensuring that all Americans, and ultimately the entire world, benefit from new knowledge and technological capabilities. Generating and analyzing information are not enough—we must overcome barriers to using data to improve health and healthcare. I have no illusion that I have the solutions to these problems, but I am grateful for the opportunity to work with a company and a university that are letting me give it a shot!

 

Further Reading:

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

DEA Approves FDA-Approved Insys Synthetic Marijuana

DEA Approves FDA-Approved Insys Synthetic Marijuana | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Insys Therapeutics, a pharmaceutical company that was one of the chief financial backers of the opposition to marijuana legalization in Arizona last year received preliminary approval from the Drug Enforcement Administration this week for Syndros, a synthetic marijuana drug.

 

Insys gave $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona year (read “Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign”; http://sco.lt/4vyNdJ). The donation amounted to roughly 10 percent of all money raised by the group in an ultimately successful campaign against legalization. Insys was the only pharmaceutical company known to be giving money to oppose legalization last year, according to a Washington Post analysis of campaign finance records.

 

Syndros is a synthetic formulation of THC, the main psychoactive component in the cannabis plant. It was approved by the FDA last summer to treat nausea, vomiting and weight loss in cancer and AIDS patients. The DEA approval places Syndros and its generic formulations in Schedule II of the Controlled Substances Act, indicating a "high potential for abuse." Other Schedule II drugs include cocaine, morphine and many prescription painkillers.

 

"It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets," a spokesman for Arizona's marijuana legalization campaign said of Insys last year.

 

Insys is also the subject of numerous state and federal criminal investigations, as well as a shareholder lawsuit, over its aggressive marketing of a product containing the potent and deadly opioid painkiller fentanyl. In December, the FBI arrested the company's former chief executive and five other executives on charges that they "paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression." [See http://sco.lt/5f8yLx]

 

In addition to its synthetic marijuana products, Insys is also developing a drug to treat opioid overdose.

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

John Carroll, Editor-in-Chief of EndPoints, to Trump: Don’t Bet on a Faster FDA to Lower Drug Prices

John Carroll, Editor-in-Chief of EndPoints, to Trump: Don’t Bet on a Faster FDA to Lower Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[John Carroll, comes down hard on failed Duchenne drug & Donald Trump’s criticism of FDA in a recent “Thumbs Up/Down” opinion piece.

 

Regarding a failed Duchenne drug, Carroll says:]

 

I never understood why the EMA would suddenly reverse itself in 2014 and allow PTC to sell ataluren as its only approved therapy on the continent for Duchenne muscular dystrophy. And it was even more perplexing to see the European regulator come back last year and decide to allow the drug to remain on the market as PTC lined up a new late-stage study over an expansive 5-year grace period.

 

At that point, not only did the EMA know full well that the drug had simply failed a Phase III trial for Duchenne, supposedly designed so that it would overcome the flaws in its failed Phase IIb trial, but the FDA had locked the door to PTC’s executive crew, unwilling to spend any time reviewing a drug that was woefully unacceptable for marketing.

 

This week, PTC put what should have been the last nail in ataluren’s coffin with fresh evidence that this drug is a dud. It failed the Phase III for cystic fibrosis. Case closed.

 

Except that it’s not and won’t be. This drug will continue to be sold despite the fact that it has repeatedly and decisively failed to clear late-stage trial hurdles. Even NICE was willing to endorse it for the UK after working out a price with PTC. PTC expects to earn more than $100 million this year from sales. And it has the backing of patient advocates — Duchenne families — who swear by it.

 

As we found out from Sarepta’s Exondys 51, though, regulators can be persuaded to overlook gaping holes in a Duchenne drug’s development program to make way for an approval (read “Path Taken by Sarepta NOT a Good Model for Other Rare Drug Approvals, Says FDA Official Who Should Know”; http://sco.lt/7stCs5).

 

There has to be a better way. If the FDA and EMA want to handle new drugs for Duchenne MD according to a different standard, then they should set up special groups inside the agencies that can help biotechs direct small but better designed studies that can offer real-world evidence of efficacy and safety. The path we’re on now is a disaster for patients, families and the societies forced to pay for these wildly expensive, unproven drugs.

 

[Regarding president Trump’s criticism of FDA’s approval process, Carroll says:]

 

The drug approval process, he says, is slow and burdensome (read , and he plans to make some big changes (here; http://sco.lt/8bbHJB). If you deregulate drug development, he has said before, drugs can speed through the FDA faster and the price will drop.

 

That, of course, is simply ridiculous. We’ve seen quite a few drugs speed through the review process in the last few years, and the price was in no way discounted as a result.

 

When Biogen, which has its own efficiency issues to address, got an approval for Spinraza last December just three months after it was filed, do you think the big biotech offered a discount as a result?

 

Not a chance. It priced the rare disease drug at $750,000. With its Tecfidera franchise on the wane, Biogen needs new revenue to satisfy investors. And how is that in any way unusual?

 

Gilead was a model of efficiency and expertise when it whipped through a development program for new hep C drugs. Sovaldi was the third drug approved under the FDA’s breakthrough drug designation, designed to help speed development timelines. It originally cost a small fortune. Cancer drug development has been revolutionized by the BTD program over the past few years. Have prices come down?

 

There are things that the FDA can do better that will lower some drug costs. But unless the president plans to simply gut development rules — a real possibility — don’t look for a faster FDA to bring down drug prices. Lower costs on drug programs do not lower prices.

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

@BobEhrlich_DTC Predicts Politicians – Including Trump - Will Huff and Puff But Not Blow Down High Drug Prices

@BobEhrlich_DTC Predicts Politicians – Including Trump - Will Huff and Puff But Not Blow Down High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bob Ehrlich, Chairman of DTC Perspectives: I really have no way of knowing what will happen in health care, DTC spending or regulation. I do, however, have an informed opinion on where we might end up. So, for what it is worth here goes for 2017.

 

DTC will continue to thrive no matter what the politicians decry about greedy drug companies. We have the first amendment and DTC generally works well as a promotional strategy. True, Congress knows the drug industry is an easy target. They also know that drug marketing employs lots of people in their districts. So they will huff and puff but in the end not adopt any rules to make drug ads harder to execute.

 

Trump is a real wild card as far as drug pricing actions. He may threaten drug companies with Medicare price negotiation and actually mean it. On the other hand Trump knows that forcing prices down could hurt jobs and innovation. More likely he will arm twist drug CEOs to pricing self restraint and then tweet his victories.

 

[Some other pundits think more positively about Trump, at least for pharma advertising & marketing: “Industry Pundits Think Trump is Good for Pharma Advertising & Marketing”; http://sco.lt/72BxHV]

 

The FDA will get an overhaul to be faster decision makers on new drug approval and hopefully that will include the glacial moving OPDP. Nothing against the generally nice folks who work there but please try doing research that actually gets done in a timely fashion. Also, the social media train left years ago but OPDP cannot seem to accept consumers know how to easily one click to see warnings and risks.

 

Further Reading:

 

DTC media mix will continue its evolution towards social media and point of care, but nothing indicates that mass media will decline. Drug companies have better mass media targeting tools and that means getting more effectiveness. In fact more specialty brands are using television because the mass awareness, although inefficient, still brings in enough new customers that justify the expense.

 

Further Reading:

  • “Is DTC Drug Advertising Effective? More - & BETTER - Research is Necessary”; http://sco.lt/7afJmD
  • “Big Pharma Spending on TV Ads Like a Drunken Sailor”; http://sco.lt/8epI6z

 

Expect more drug company corporate media and DTC advertising efforts to justify drug prices. There are valid reasons for high prices in most cases, but Americans are perplexed why they pay more than other developed countries. It is a very tough sell but Americans are demanding to know what the premium price is getting them.

 

[Also, pharma marketers will have to be more creative in explaining the benefits of high-priced drug “21st Century Cures for Pharmaceutical Marketing”; http://sco.lt/4rDC65].

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

If Trump Taps O’Neill for FDA Commissioner, Consider It an Rx for Bad Health

If Trump Taps O’Neill for FDA Commissioner, Consider It an Rx for Bad Health | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of two people that Trump is considering as the next Food and Drug Administration commissioner gave a speech two years ago in which he suggested the agency require only safety testing for new drugs. After that, good luck.

 

“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” said Jim O’Neill, a managing director at Mithril Capital Management, a venture capital firm run by Peter Thiel, the billionaire Trump donor and transition team advisor. “Let’s prove efficacy after they’ve been legalized.”

  

He is not the right person for the job. O’Neill is not a scientist or physician. Most FDA commissioners have had such a background, because the training involved in both careers makes it easier to understand the myriad issues involved in moving medicine forward.

 

So what does he offer? Basically, O’Neill is a policy wonk with good connections and a steadfast belief in the power of free markets. A former policy adviser at the Department of Health and Human Services, he now funds early-stage biotech companies and likes to lambaste the “cartelized” health care system for hindering the development of health care products.

 

“Waiting to figure out whether a drug works after it’s available is naive, because drugs don’t work like the markets for pens or so many other products,” said Daniel Carpenter, a political scientist at Harvard University who has studied the FDA. “We would be turning the clock back nearly a century, and the legitimacy of the American medicine cabinet would crater.”

 

Indeed, O’Neill’s notion would be like letting the proverbial genie out of the bottle. In some cases, patients may benefit from the famous placebo effect — maybe they think a drug is working simply because they took it. More important, it is likely to be very difficult to organize proper clinical trials to determine effectiveness once a drug is widely used.

 

But you may ask, ‘What’s the harm? If the drug is safe, why not let people try it?’

 

Well, most drugs are not safe, actually. They’re approved because clinical trials have shown that on balance, they help more than they hurt.

 

Keep in mind that even if Trump appoints O’Neill and he’s confirmed as the new FDA chief, he cannot unilaterally overhaul the drug approval process.

 

The 1962 Kefauver-Harris amendments to federal law require trials to demonstrate adequate safety and effectiveness. So Congress would have to get involved to change the system. Still, that seems entirely possible given the Republican penchant for deregulation.

 

Naming someone with such radical ideas as FDA commissioner would not serve the public.

Pharma Guy's insight:

I heard that bipartisan support is rising for Scott Gottlieb -- a fellow at the American Enterprise Institute for Public Policy Research, a conservative think tank -- as FDA commissioner. Gottlieb may be as radical as O'Neil regarding deregulation although he may not be as politically incorrect about it. I'm beginning to think that Trump is throwing out scary names so that he can pick less scary people who will do the same thing and Congress will not have to take criticism for OK'ing the appointment!

 

Related articles: 

  • “Think Califf's Job is Safe? History & Trump's Promises Would Suggest Otherwise “; http://sco.lt/71n7YH
  • “Why Donald Trump's Putative FDA Pick Should Scare Pharma & Patients”; http://sco.lt/62EHSL

 

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

PinUp: FDA Muzzles Journalists, Cancer Drug.com Sites Emphasize Positive, Prescribing Medical Mobile Apps, More...

PinUp: FDA Muzzles Journalists, Cancer Drug.com Sites Emphasize Positive, Prescribing Medical Mobile Apps, More... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Welcome to the September 27, 2016, issue of Pharma Industry News Update (aka PinUp). PinUp is published every Tuesday as part of your Pharma Marketing News subscription service. It features curated pharma industry news and views of topical interest from a variety of sources.

 

---------------

Featured Event

West Coast Electronic Benefit Verification & Prior Authorization Summit

25 - 26 October 2016 | San Francisco, CA

http://bit.ly/MTG1355fl

 

---------------

How the FDA Turns Journalist Watchdogs Into Lapdogs

  

Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access - including ones from major outlets such as Fox News - and even deceives them with half-truths to handicap them in their pursuit of a story. 

 

More here... http://sco.lt/9AcuG1 

 

FDA isn't alone in manipulating the press. Read, for example, "Academics Exaggerate, Journalists Regurgitate"; http://sco.lt/8sNzPN  and "Bad Journalism Abets Bad Pharma: Philly Inquirer Editors Raked Over Coals"; http://sco.lt/7rkRZB 

 

---------------

Just Like DTC Ads, Pharma Cancer Drug Websites Emphasize Benefits Over Risks

 

Researchers from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) and research firm RTI International say that websites for cancer-drugs are ten times more likely to include quantitative information about all the benefits of a drug versus all its risks.

 

More here... http://sco.lt/8soJrV 

 

Also read: "Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients"; http://sco.lt/8Imgdd  and " Breakthrough Cancer Therapy DTC Advertising Boldly Emphasizes the Positive"; http://sco.lt/80LqSX 

 

---------------

Apple Hires YouTube @DocMikeEvans to Prescribe Health Apps!

 

Mike Evans, known on YouTube as "DocMikeEvans," has joined Apple to work on digital health care. Evans is best known for his videos where he narrates while an animated doctor gives health tips and advice.

 

"In future, I'll prescribe you an app. One of our whiteboards will drop in and explain what high blood pressure is. The phone will be Bluetoothed to the cap of your pills. I'll nudge you towards a low salt diet. All of these things will all happen in your phone. I see you two or three days a year. The phone sees you everyday."

 

 

More here... http://sco.lt/5urPMX 

 

You might also be interested in reading: "AMA CEO Calls Out Medical Apps as 'Digital Snake Oil'"; http://sco.lt/8zuIld  and "Most Doctors Not Yet Ready to Recommend Mobile Apps & Wearable to Patients"; http://sco.lt/8yujoX  and " Kevin Pho, MD, is not ready to prescribe mobile health apps. Why not?"; http://sco.lt/8oj9rV 

 

---------------

Forget Mobile-Enabled Web - You Need an App for That + Video!

 

This year, US adults will spend 1 hour and 54 minutes a day using apps on their smartphones, 7 minutes more than last year. In contrast, they’ll only surf the mobile web on their phones for 19 minutes a day, a decline of 2 minutes from last year. In other words, apps will account for 86% of adults' nonvoice smartphone time this year, with the mobile web accounting for just 14%.

 

More here... http://sco.lt/7QzAbR 

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

Researchers Call for FDA Transparency To Avoid Black Box Warning "Flip-Flopping"

Researchers Call for FDA Transparency To Avoid Black Box Warning "Flip-Flopping" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A team of Harvard researchers are calling for the US Food and Drug Administration (FDA) to develop guidelines detailing its decision-making process for removing black box warnings from drug labels.

 

For example, the researchers point to two recent cases where drugmakers petitioned FDA to lift a black box warning from one of their products.

 

In one case, Pfizer unsuccessfully petitioned FDA to lift a boxed warning for severe psychiatric events, including suicidality, from its smoking cessation drug Chantix. Five years after FDA recommended a boxed warning on the label for Chantix, Pfizer asked the agency to remove the warning based on data from five short-term observational studies.

 

However, after convening a joint meeting of its Psychopharmacology Drugs and Risk Management Advisory Committees, FDA opted to maintain the black box warning for the drug.

 

In another case, GlaxoSmithKline (GSK) managed to persuade FDA to remove the black box warning for its blockbuster diabetes drug, Avandia, using an independent analysis of data from a large randomized open-label controlled trial.

 

In both cases, the researchers say FDA's decision to impose a black box warning was based on less evidence than was necessary to support the removal of a warning. This is necessary, they argue, as FDA must act quickly to protect patients when safety issues emerge.

 

However, when it comes to removing a warning, the researchers argue that FDA should require more substantial evidence than it used to impose the warning in the first place.

 

"To avoid frequent flip-flopping, we believe it is ethically justified for the FDA to require a greater burden of proof, or a greater level of certainty provided by the evidence at hand, to justify removal of a boxed warning than it did to impose one," they write.

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

Pay Attention! FDA to Study If Oldsters Understand TV Drug Ads

Pay Attention! FDA to Study If Oldsters Understand TV Drug Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration wants to figure out just how well older Americans are able to comprehend the prescription drug ads they see on TV.

In an upcoming study, described in a notice posted publicly late last week, the agency will test whether Americans 60 and older understand some of the more complex information presented in the commercials they see between network news and NFL football games. They want to test whether people understand more complex ads as well as they did simpler ads — or if it is too much information for people to process.

Americans 60 and older will participate in the studies, the agency said, because they are more likely to be interested in the drug being studied and therefore more motivated to pay attention. The FDA noted that older people use more prescription drugs and watch more television than younger people.

Participants will be shown TV ads twice for a fictional medication for cataracts. They will then take a survey gauging how well they understood the information in the ad, how well they retained the information, and how they ultimately perceived the drug’s risks and benefits.

The ads will vary. Some will describe side effects more simply, for example, occurring in “10 percent or less” of patients; others will be much more specific — say, 6 percent to 10 percent. Some ads will give only a single outcome for taking the drug (52 percent improved their vision); others will offer an additional outcome (52 percent improved their vision and people were able to see on average 85 out of 100 letters in an eye chart test).

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

Patient Testimonials aka Anecdotal Experience #Pharma Marketing

Patient Testimonials aka Anecdotal Experience #Pharma Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals.

There appears to be good reason for the use of testimonials by patients when seeking to promote a medical product. A patient like me who has faced what I faced and now has been through the experience tells me what it is like, and I may take great stock in what they say.

But while it may make sense, there may be inherent regulatory risks in going down that path – risks that are peculiar to use of testimonials. Why?

Part of the appeal in having a patient describe their experience using a medical product is that they provide a real, first-person description of how the product worked for them and the difference it made for them with respect to their condition. That is also the drawback.

I was able to identify 12 instances in which FDA sent a letter regarding a communication that involved a patient testimonial – in 3 of those instances the patient was also a celebrity spokesperson.

When it comes specifically to patient testimonials, the most common violation was the overstatement of efficacy, involving 11 of the 12 letters.

The basis for that is likely that when a person describes in subjective terms their experience with a medication, it usually includes a reference to the impact the use had on their lives. Phrases such as it “literally changed my life” and “restored my confidence” or describing in personal terms the use of the medication for which evidence does not exist to demonstrate that everyone would have such an experience.

Almost all of the communications vehicles involved video, but it also involved some print.

Pharma Guy's insight:

Pharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. Can anecdotal "evidence"/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects? For more on that, read "Are Patient Stories Becoming Anecdotal 'Evidence' in Pharma Marketing Campaigns?"; http://bit.ly/patstorymkting 

more...
Pharma Guy's curator insight, March 28, 2016 8:09 AM

Pharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. Can anecdotal "evidence"/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects? For more on that, read "Are Patient Stories Becoming Anecdotal 'Evidence' in Pharma Marketing Campaigns?"; http://bit.ly/patstorymkting 

Scooped by Pharma Guy
Scoop.it!

A ‘Roadmap’ for Navigating Patient Advocacy | FDA Voice

A ‘Roadmap’ for Navigating Patient Advocacy | FDA Voice | Pharmaguy's Insights Into Drug Industry News | Scoop.it

FDA’s Center for Drug Evaluation and Research (CDER) is sponsoring a daylong public workshop on March 31, 2016, titled Navigating CDER: What You Should Know for Effective Engagement. Our presentations will help patient advocates gain a better understanding of FDA and provide specific resources to help you and your colleagues learn ways to effectively advocate and engage with the Agency on behalf of the patients you serve.

We’ll provide a broad overview of patient engagement with various offices within CDER, and drill down into key specifics such as:

  • Who and when to call;
  • How to set up a meeting at FDA;
  • Provide tips on making the most out of your meeting; and,
  • How to prepare an effective presentation for FDA staff.

 

We’ll also discuss topics such as understanding labeling, generic drugs, and how patients can effectively interact and provide input to FDA. And, we’ll look at some programs including different drug approval processes, expanded access, and FDA’s role in patient focused drug development (PFDD).

 

These are only a few of the many important areas we’ll tackle.

more...
No comment yet.