Thoughts on the FDA

Medicating the FDA

When FDA grants marketing approval, the drug is deemed safe and effective for the conditions on the label. The company and FDA painstakingly discuss the labeling, to specify uses, dosage, warnings and side effects. And at the end of the day, if FDA isn’t completely satisfied, there’s no label ” and no approval.

FDA is not the only gatekeeper restricting consumer access to prescription drugs: Physicians must prescribe them and, for many Americans whose drugs are paid for by an HMO plan, the health insurance formularies must include them.

Visiting a doctor is not like going to the supermarket, where you put in your cart whatever you want: Physicians are (or should be) accustomed to saying no to patients who demand specific therapies. Many doctors now firmly ” and correctly ” deny patients unneeded and ineffective antibiotics for virus-induced colds, and routinely do the same for other drugs.

The efficient detection of ADEs is essential, and the United States needs improved pharmacovigilance ” monitoring the safety of approved drugs. This should be done not by creating a new, independent agency, but by fixing the FDA. However, it is questionable if the newly announced FDA Drug Safety Oversight Board, which will monitor approved medicines’ safety, is the answer.

We need better data rather than more bureaucrats. In any case, public health is more imperiled by lack of drugs in the development pipeline ” a legacy of decades of FDA over-regulation ” than by side effects from approved drugs).

To improve pharmacoviligance, we need to encourage physicians to report side effects, perhaps by rewarding them with the Continuing Medical Education credits needed to retain licensure; to contract with organizations that treat large patient populations to monitor and report adverse events; and to share data with foreign regulators. We might also consider some variation of the U.K.’s “yellow card” system, in which doctors, dentists and pharmacists report ADEs to federal regulators (on a small, simple yellow card, of course).

Our drug development and regulation system needs reform. But we must make sure the cure isn’t worse than the disease.