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Pharma lobbying in the US

Is it a matter of freedom of speech?
Freedom of Speech

Whistleblowers. Secretive lobbying. Hushed conversations in the halls of corporate America. Sensational litigation trials. This is the stuff of Hollywood for sure. Actually, it's the stuff of the pharmaceutical industry.

For years the pharma lobbyists have been advocating for the unimpeded flow of information to physicians citing the US constitution's First Amendment as the basis for their thinking. The First Amendment states that “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances”. Pretty heavy stuff, no?

The question is: who decides what should be shared and who should do the sharing?

So how did our industry end up in the position where the First Amendment and freedom of speech is being used as a shield to allow pharma companies to knowingly disseminate information about their molecules where the long-term safety, tolerability and efficacy data is, at best, unclear? How did we end up with well-heeled lobbyists on Capitol Hill beating the drum vociferously to allow drug representatives to suggest that Topamax which is approved to treat seizures and migraine headaches might be used in alcohol dependency or that Neurontin which is approved for epilepsy might be helpful in bipolar disorder or insomnia ? In part, we ended up in this position because of the landmark US v Caronia case. Alfred Caronia was a pharmaceutical sales representative for Orphan Medical who, together with a physician in Orphan's speaker programme, promoted the drug Xyrem for off-label uses. After a trial, Caronia was convicted under specific sections of the Federal Drug and Cosmetic Act (FDCA).

But then the Second Circuit Court of Appeals overturned Caronia's conviction, citing his first amendment rights. It declared, unequivocally, that the government “cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug”. In larger reality however, the US v Caronia case is but one of the elements in this ongoing battle between the industry, the regulators and the government that has shed light on the issue.

The argument that time-consuming and expensive clinical trials for every indication serve no one's best interest because of the delays in making potential useful therapies available is fair. The argument that in today's day and age with the rise of social media and sophisticated platforms that make data overwhelmingly easy to access and that render drug labels out of touch with realworld practice is also fair. The argument that clinicians rely on manufacturers who know more about the molecules they promote than anyone for up-to-date and relevant information is acceptable.

The other arguments are also just as persuasive however. That the FDA serves a purpose by requiring rigorous trials to validate a drug's safety and efficacy and that circumventing this would put us on a very slippery slope. That an individual or company with much to gain financially by virtue of promoting the off-label use of its drug is in a conflict-of-interest position. That we need to distinguish between 'active' off-label promotion and unsolicited off-label requests from clinicians because somewhere and somehow the information that helps advance treatment needs to be shared.

Have we taken the freedom of speech argument too far? Are we really comfortable with leading the charge for our drugs to be used in patient populations for which there is no indication and, more importantly, no definitive body of evidence touting their safe use? Is it up to us as an industry to fight this battle? Or are the current regulations around off-label promotion so antiquated, restrictive and over-protective that some coordinated effort is necessary? There is no debate that the off-label utilisation of drug molecules in unapproved indications takes place and, in many instances, gets published or presented at the podium. The question is: who decides what should be shared and who should do the sharing?

The unfortunate part of this debate is that it seems to have turned into a constitutional argument about what ought to be allowed to be said as a matter of principle. It has become a conversation about how manufacturers should be able to have a louder voice and greater role in the dissemination of off-label information. Instead, what's really important is the mechanism by which we get information to clinicians so that they can make treatment decisions that advance care for patients. If that means that industry is removed from the process and we leave clinicians to get this information on their own with some degree of modified or restructured regulatory oversight, then so be it. There are many actors in this play who would not mind one bit.

Article by
Rohit Khanna

is the managing director of Catalytic Health, a healthcare communications, advertising & strategy agency. He can be reached at:

22nd October 2014

From: Marketing, Healthcare



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