Slow, and Then Too Slow

The Food and Drug Administration has long been criticized for painstakingly scrutinizing drugs rather than swiftly approving them and, in some cases, allowing more lives to be saved. For years, especially before the tenure of David Kessler as director, its rigid approval process led pharmaceutical companies, AIDS activists and others to dub it the “Foot Dragging Agency.”

The FDA’s proposal Monday to ban the antihistamine Seldane, however, raises vital questions about whether the agency may be as lax at assessing drugs after they have been approved as it is diligent at evaluating them before approval.

Since the FDA approved Seldane in 1985, the agency now says, at least eight people have died from taking the popular allergy drug in combination with certain other medications, and hundreds more may have been adversely affected.

The agency’s handling of the Seldane matter makes two things clear:

1. The FDA should have banned Seldane sooner. In the summer of 1996, the agency approved a chemical equivalent of Seldane that lacks its potentially toxic interactions. At that point, it should have proposed banning Seldane. It did not do so. In fact, it approved marketing of a generic version of Seldane only last year, long after the antihistamine’s dangers were known.

The FDA’s inaction is particularly troubling because private industry certainly seems to be accepting no responsibility in the case. Hoechst Marion Roussel, Seldane’s chief manufacturer, says it will continue to “aggressively defend the product.” Its reasons for doing so are understandable: The company is now fighting myriad product liability suits brought by consumers who allege they have been harmed by the drug. By pulling Seldane from the market, the manufacturer could jeopardize its legal position.

2. The FDA should ensure that consumers, not only physicians, are fully informed of dangerous drug interactions. While some pharmacies voluntarily provide some drug information to consumers, and while all drug companies have been required to notify physicians of dangers since 1938, only Tuesday did the FDA announce a plan to pass on comprehensive information to consumers.

The new Patient Information Program exhorts physicians and pharmacists to reveal prescription drug information to 75% of patients by the year 2000 and to 95% of patients by 2006. The rub is that the program, in addition to being voluntary, will not be evaluated by the FDA until 2000 and 2006.