A Harvard medical professor has urged the Food and Drug Administration (FDA) against easing the restrictions on drug companies marketing their drugs for uses for which they have not been approved—so-called off-label use.
During the summer of 2015 the FDA will hold a public meeting to discuss whether restrictions on what claims drug manufacturers can make about their products improperly infringes the liberty of those companies, HealthNewsReview reports. Dr. Jerry Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Boston’s Brigham and Women’s Hospital, writing in the Annals of Internal Medicine, argues that patients and doctors need the “sovereign” power of the FDA to regulate what claims drug makers can make.
The pharmaceutical, biotech, and device industries contend that the government should regulate very little. They argue that the marketplace will sort out which drugs work and are safe. Outright fraudulent claims would still be prohibited but short of that, advocates argue that most kinds of “scientific evidence” should be grounds to promote both new and old products, whether or not the FDA agrees. But Avorn says that in his years of practice as an internist, he has “taken comfort that drugs on the market were there because their manufacturers had provided the Food and Drug Administration with at least some evidence that they worked, and that their known risks were depicted in the product labeling.” Avorn says he did not need to review the available evidence about efficacy and safety on his own for each drug he prescribed, according to HealthNewsReview.
Avorn explains that the FDA’s power to require efficacy data dates back only to the 1960s. The thalidomide birth defects tragedy convinced Congress to give the FDA new authority to ensure that useless or minimally effective products, or drugs with unacceptable safety problems, could not come into use. Avorn warns that weakening those regulations would be a step backwards in the safety of prescription drugs. He points out the kind of “ludicrous” claims made in the marketing of dietary supplements as an example of what could be expected if off-label marketing is not restricted.
The proposals under consideration would allow companies to short-circuit the need for a review of all available data—including companies’ proprietary information—and permit them to present clinicians with “cherry-picked studies that may look good in isolation but could be methodologically inadequate, or fail to present a balanced picture of a drug’s benefits and risks,” Avorn writes. He also points to the unreliability of “clinical experience” measures such as “observational studies, registries, and therapeutic use” as well as guidelines to assess efficacy, according to HealthNewsReview. Yet under the proposed regulations such measures would be permissible in drug company promotion of products.
Dr. Avorn recently wrote on this same topic in the New England Journal of Medicine. In conclusion he writes, “Over the past 80 years, this country’s regulatory approach has embraced steadily improving criteria for accurately assessing therapeutic efficacy and risk. Patients and physicians would not benefit from legislation that instead of catapulting us into the future, could actually bring back some of the problems we thought we had left behind in the 20th century,” HealthNewsReview reports.