Listen closely, and you’ll hear the other shoe dropping.
For several years FDA has been besieged by litigation brought by drug makers and their supporters which argued that the agency’s limiting companies’ promotional claims violated those corporations’ First Amendment-protected rights to ‘commercial free speech.’
Then the 21st Century Cures Act signed by still-President Obama in December of 2016 authorized FDA to consider less demanding standards in approving medications. 2017 began with a new administration vowing to free the pharmaceutical industry from the onerous regulatory burdens of the FDA. Now all these forces are coming together in a worrisome confluence of regulatory derangement.
The House Energy and Commerce committee in mid-July held hearings on how best to implement the Congressionally mandated loosening of drug approval standards set forth in the “Cures” act. At the same time, the new FDA Commissioner has argued that FDA’s “public health mandate” should be met by relieving manufacturers of some of those troublesome requirements to demonstrate clinical benefit, in order to get drugs to the public more easily. At the same time, he noted, as FDA reduces the complexity and duration of the drug approval process, this speeding of new drugs onto the market will help contain their high prices.
Nevermind that FDA’s approval process is already the swiftest in the world, clocking in at a mere 6 months for priority decisions.
And nevermind that the cost of the regulatory process accounts for only a small portion of medication prices.
And just ignore the fact that worrying about cost never has been part of that agency’s mandate.
Justifying the reduction of FDA’s regulatory standards to meet its “public health mandate” is a troubling Orwellian development that is likely to have exactly the opposite effect. It is eerily reminiscent of the notorious Vietnam-era claim by the military that a village “had to be destroyed in order to save it.” Invoking FDA’s public health mission to justify approving drugs that have not been adequately shown to help patients is both bizarre and irrational.
These developments raise the ante for evidence-based prescribing in general, and for academic detailing in particular. Most clinicians and health care systems are not yet aware that FDA approval may become an eroded imprimatur to guide medication decisions, and most people will continue to believe that pharmaceutical company claims have to pass muster with FDA for their accuracy, even as this becomes less and less true in the coming years.
Even if we cannot stop these disturbing developments, we must at least make sure that they are understood by our colleagues in medicine, so that academic detailing services – by definition rigorously evidence-based and non-commercial – can play an increasingly large role in informing prescribing decisions, as an antidote to these worrisome ongoing developments.
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Biography. Jerry Avorn, MD, Co-Director, NaRCAD
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist and drug epidemiologist, he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use.
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