Can the FDA prohibit free speech?

Maybe not (NEJM 2013; 368: 103-05).

While the FDA is responsible for overseeing the safety of pharmaceuticals and veracity of marketing, its authority does not extend to the practice of medicine.  This enables the widespread practice of using medications for “off-label” purposes.  Physicians can use approved drugs for nonapproved uses.  FDA regulations have restrained marketing of off-label uses of prescription medications by pharmaceutical representatives.

However, a recent appellate ruling in United States v. Caronia has stated “the government cannot prosecute pharmaceutical manufacturers…for speech promoting the lawful, off-label use of an FDA-approved drug.”  According to this perspective article, the ruling stemmed from the argument that refusing to “allow the free flow of information would result in …limitations, and side effects of the drug.”

At stake is whether the ability of the FDA to combat false or misleading speech.  In addition, limiting the FDA’s authority may lead to fewer studies documenting the effectiveness of medications for various indications.  If the medication is approved for one use and there are no constraints on marketing, there will be little incentive to complete additional studies.

Additonal references:

UNITED STATES V. CARONIA 09-5006-cr Unofficial Oral Argument …

United States vCaronia – Reed Smith

7 thoughts on “Can the FDA prohibit free speech?

  1. Jay: thank you so very much for bringing up this critically important topic – particularly for children and the potential impact on the approval of therapeutic compounds.

    A few provocative musings to continue the dialogue and discussion;

    1) there is still not a lot of general knowledge of the strides that led to and/or have been made since the FDAMA legislation came to pass in 1997.

    2) the FDAMA legislation ‘sundowned’ in 2005 and there are a number of important pieces of FDA regulatory rules and guidance that were modified from the original Act and language, in essence; – at present, although this legislation has gone through numerous “attacks” and iterations – there is still the assurance (hope) that ANY pharmacological agent which is being brought to the FDA must have proposed studies that involve children submitted in a “written request”

    3) the following FDA “Acts” which have children specifically in mind exist, namely; – FDA Safety and Innovation Act (Pediatrics in Section V) – FDA Amendments Act of 2007 – Best Pharmaceuticals for Children Act of 2007 – Pediatric Research Equity Act of 2007

    4) HOWEVER there are still fundamental differences between the FDA and EMEA the European equivalent of the US regulatory agency in that the EMEA requires the company to submit BOTH a pediatric and adult plan, and initiate the studies simultaneously whereas – in the U.S., the adult studies can be done first, the sponsors often try to find ways to extrapolate from the adult studies to children thereby reducing the number of studies, and/or children that need to be studied in order to get the indication and labeling

    5) many times the studies used to get labeling and approval for compounds in children; – have much smaller number of total patients studied than for adults – often don’t advance the science and simply demonstrate “safety” and dosing – may or may not include an active comparator, and/or are designed to show lack of inferiority (i.e. just show that the new drug is no worse than what is available)

    6) in addition, and more importantly for the pediatric subspecialist, – even if a pharmacological agent gets its approval, there are no standard guidelines in place that mandate, much less even suggest routine prospective, post-marketing safety monitoring and surveillance of adverse events and safety…and – there are relatively few products now that the FDA currently has enforced the Industry Sponsor to assure, both in their written request, and in real practical terms, actually conduct that evaluate safety in pediatric patients who require the agent “long” term; – e.g. the Janssen-Centocor-FDA long term safety study evaluating Remicade safety is one of the very few examples of this type of post-marketing surveillance for safety being done;

    7) finally, and most appropo to the recent judgement that this blog so astutely brings to the forefront is that there is no real legislation, mandate, or language which enforces the pharma industry in general to; i) address what happens when drugs go “off patent” and become generic – and whether these agents are similar or different in their efficacy and safety profiles as the prescription compound – which is what the insurance companies are “pushing” practictioners (irrespective of whether there is labeling in the pediatric patient) to prescribe, even with a lack of or no data, and, ii) perform studies with over-the-counter agents, ie. the drugs after they have gone off label that assess efficacy and safety

    Thanks again for the science, practical approaches and thought provoking important issues that your blog continues to bring forth.

    Ben Benjamin D Gold MD

    Sent from my iPad

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