Pharma Industry Regulation
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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? | Pharma Industry Regulation | 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 10, 2016 6:38 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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