THE FDA IS BROKEN. HOW CAN IT BE FIXED?

In a recent NY Times article, reporter Barry Meier discussed Medtronic’s acknowledgment that some 13 deaths have been attributed to malfunctions of a device it manufactured –a small cable, known as the Sprint Fidelis, that connects an implanted defibrillator to the patient’s heart.  Apparently, Medtronic knew the device was failing shortly after it reached the market in 2004, according to the FDA’s investigation into the product’s failures.  Yet the device was not recalled until 2007.  Where was the FDA “oversight” that should have protected such patients?

The NY Times article provides a meaningful introduction for an article published the next day by The New England Journal of Medicine , entitled “ A To-Do List for the New FDA Commissioner .”  Susan Okie, M.D., one of the NEJM’s national correspondents, provides some well-thought-out suggestions for how to fix the dysfunctional government entity.  For starters, the new commissioner needs to take a bipartisan approach to securing increased federal funding, as new employees must be recruited and trained.  Additionally,  the agency’s information-technology system is obsolete, and must be replaced.

The new commissioner must restore credibility to the FDA, and this means attaining increased transparency immediately.  This will be a challenge, as the agency has long maintained an insular culture that frowned on dissent.

The food-safety operations at the FDA must be streamlined and centralized.  At present, food regulation is handled by three different departments of the agency, and more than eleven additional federal agencies take part.  Dr. Okie notes that the fallout from the recent outbreak of salmonella prompted President Obama to make a review of food-safety operations at the FDA a priority.

The agency’s process for approving medical devices needs attention as well.  As Dr. Okie points out, “the 1976 law granting the agency authority to regulate medical devices allows it to approve certain new devices without clinical testing of safety and efficacy, provided they are deemed substantially equivalent to devices already on the market.  Despite 1990 legislation ordering the agency to begin requiring more extensive clinical studies of class III devices (those implanted in the body) before approval, most are still approved with minimal testing.”  This has resulted in exactly the type of problem discussed in the NY Times article on Medtronic’s Sprint Fidelis device.

Lastly, the agency must act immediately to share developing concerns about the safety of drugs with doctors and the public.

Is President Obama’s nominee for commissioner, Dr. Margaret Hamburg, up to the task?  After six years as New York City’s Health Commissioner, I’m betting that she is.