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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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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The FDA Now Officially Belongs to Big Pharma

The FDA Now Officially Belongs to Big Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved today as the next FDA commissioner. Vocal opponent Bernie Sanders condemned the vote from the campaign trail. But where was Dick Durbin? Where were all the lawmakers who say they care about industry and Wall Street profiteers making money at the expense of public health?


Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.


Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA.


In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?


Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?


He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)


Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Xarelto's serious and foreseeable risks were back in the news this week.


Duke, where Califf directed clinical research, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a "60 Minutes" special. It is the least appropriate place from which to choose an FDA commissioner.

Pharma Guy's insight:

Regarding Duke, you might be interested in reading this: "Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?"; http://sco.lt/5mZaL3 

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Pharma Guy's curator insight, March 28, 2016 8:05 AM

Regarding Duke, you might be interested in reading this: "Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?"; http://sco.lt/5mZaL3