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Physician urges FDA not to lift restrictions on drug makers’ claims about their products

Drug regulations and a governing body to mandate them is a necessity for patients’ safety and health care providers’ peace-of-mind, according to a recently released commentary in the Annals of Internal Medicine.

“As a prescriber, I have been willing to give up my freedom to prescribe any chemical I choose to patients, and I am willing to have drug manufacturers give up some of their right to tell me whatever they may want me to hear. For all of us (including patients) to hand over some liberties to a Hobbesian Sovereign, such as the FDA, offers a different kind of freedom — knowing that the medications we use are probably, at least as a first approximation, reasonably safe and have some evidence that they work,” Jerry Avorn, MD, Harvard School of Medicine, wrote in his paper.

This summer, a public meeting will be held by the FDA to discuss the restrictions on what claims can and cannot be made by drug manufacturers regarding their products. The meeting will aim to decide if the current FDA restrictions violate companies’ liberties, which many pharmaceutical, biotechnical and device companies believe they do, according to the commentary paper.

The policy revisions proposed would allow drug companies to pick and choose the study data that is presented to clinicians rather than allowing a balanced overview of the safety and efficacy of a drug, according to Avorn. Moreover, Avorn called the observational studies, registries, therapeutic use measures and guidelines that assess efficacy backed by the pending legislation “unreliable.”

Avorn pointed out how dysregulation of dietary supplements from FDA governance in the 1990s has led to “a cacophony of ludicrous unregulated and often phony claims” that “contaminate the airways, print media and cyberspace.”

Fearing the impact of lifting regulations, Avorn said that this summer’s change in policies could result in a huge step back for prescription medicines, referencing the 1960’s thalidomide tragedy, which prompted Congress to enact more rigid FDA regulations in the first place.

Avorn stated that he takes comfort in knowing that the drugs he prescribes his patients have been assessed by the FDA and that drug risks are marked right on the labels. Without FDA regulations, he is unsure how he, or any other practicing internist, would have the time to research and assess each and every medication prescribed.

“Rather than representing an infringement of companies’ inherent rights as ‘citizens,’ maintaining our current standards for promotional statement can keep us from sinking back into an ‘all against all’ state of poorly founded drug claims and understated risks. Yielding to the pressure to do otherwise would risk making out patients’ lives more poor, nasty, brutish and short than they have a right to expect,” Avorn concluded. – by Casey Hower

Disclosure: Avorn reports no relevant financial disclosures.