American Elephants


Schooling the FDA On The Meaning of the First Amendment by The Elephant's Child

_78425952_517716225I’m afraid I’m becoming something of a crank, grumbling constantly about the depredations of bureaucracy. The Food and Drug Administration has believed its powers so encompassing that it can even prohibit drug companies from making true statements about their products unless they are approved by the FDA.

A federal judge has just called this political control a violation of the First Amendment. Once the FDA has approved a new drug for FDA specified uses, physicians often repurpose them in other doses, or for other diseases, or for entirely different patient populations. A drug designed for breast cancer might prove effective against tumors in other parts of the body, or a medicine for adults may prove effective for pediatric care. About one of every five U.S. Prescriptions is for non-FDA approved uses.

In a small miracle, these off-label experiments are legal, and they drive innovation. The artificial conditions that the FDA demands for clinical trials are increasingly divorced from how medicine is practiced, and modern care advances far faster than the FDA’s regulatory molasses. Off-label use is vital for complex conditions like cancer and psychiatric disorders that require trial and error for individual patients, who can’t wait years for the FDA’s blessing.

But the FDA and Justice Department are targeting off-label prescriptions as a threat to their hegemony. Their goal is to force drug makers and physicians to seek FDA approval for every new real-world use, as if it were an entirely new drug. Until recently, drug makers were banned from making off-label claims backed by solid evidence or even from distributing peer-reviewed journal articles.

Prosecutors have also become increasingly aggressive. In 2012 GlaxoSmithKline paid $1 billion for encouraging doctors to use Paxil to treat depression in patients under 18, which research shows helps although the FDA has not endorsed this conclusion. The FDA construes some forms of off-label promotion as crimes, and people are serving jail time.

The nature of a bureaucracy is to grow, prosper, be better rewarded monetarily and extend its reach. Was there ever a bureaucracy that thought that much that they did was unnecessary, and they should probably downsize for the benefit of the taxpayers? I rest my case.

Judge Paul Engelmayer explained to the FDA that if they believed that a different use of a drug gravely undermined the drug approval process, it should have sought review of that decision, not tried to liken distributing information to an assault on their drug-approval authority, and tried to compare it to illegal speech such as blackmail or insider trading. Free speech wins one!

 


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