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

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

STRIKE TWO! for the FDA...


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


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


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

Pharma Guy's insight:

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


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


Now we know why the letter was yanked.


Also read:

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

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


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

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

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


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


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

Pharma Guy's insight:

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


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


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


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


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


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

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


The removal surprised FDA watchers.


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


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

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


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


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