W(h)ither the FDA?

There has been much written lately about the perceived failings of the FDA. The Wall Street Journal claims that “the place is a mess,” and a physician who served in the FDA from 1979 to 1994 commented in a letter to the New York Times: “the agency’s most significant problems are mismanagement and a culture that is excessively risk-averse.”

That same physician went beyond this diagnosis to offer a potential cure. What the FDA needs, he suggested, is competent management, discipline in the ranks, more effective risk-benefit balancing, a commitment to permitting patients to assume more responsibility for the risk of medicines, and the banishment of politics from regulatory decisions and policy.

One of the FDA’s advisory panels, the Science Board, notes that the Agency is in a precarious position because it’s chronically under funded. And the US Government accountability office asserts that at the FDA’s current pace of operations, it would take 13 years to inspect every foreign drug plant exporting to the US.

The under funding issue comes into sharp focus when one realises that the Agency’s mandate has increased exponentially over the past decade or so. In fact, the Science Board states that “while the world of drug discovery and development has undergone revolutionary change, the FDA’s evaluation methods have remained largely unchanged over the last half-century.” The Board proposes that the FDA modernise current regulatory pathways, especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.

The FDA was founded in 1906 with the laudable objective of protecting the populace against ingesting harmful or dangerous substances. It has grown into a bureaucratic monster, employing some 10,000 workers, and with a budget of more than $1.5 billion.

And the role of Commissioner has not been an entirely happy one. Since Dr. David Kessler, the so-called ‘scourge of the tobacco industry,’ stepped down after a record six year tenure, his three successors have lasted an average of two years. The present incumbent, Dr. Andrew C. von Eschenbach, has filled the role since last December. In an interview I conducted with Kessler for the British Medical Journal shortly after he resigned, he said that he had achieved his three major aims: developing and mandating the nutritional labels that now appear on all foodstuffs sold in the US; shortening the time for approving new drugs; and bringing about the legal definition of nicotine as an addictive drug and therefore subject to FDA regulation.

Often accused of zealotry and of politicising the Agency, Kessler also became the object of a congressional investigation of his allegedly padded expense accounts. But if you want to be liked, don’t be a regulator, he told me, noting that “it’s no secret that if you take on difficult issues in this town you’ll be attacked. You learn to live with criticism; you don’t confront it.”

Is there a case for privatising the Agency? Despite the 1992 scandal of some FDA scientists accepting bribes… and some dubious drug approvals, it might be that this is one area where public enterprise might be a preferable guardian of the public interest. Under the Prescription Drug User Fee Act (PDUFA) some privatisation is already occurring, with drug companies paying user fees to the FDA in order to reduce approval times. Another suggestion, put forward by Henry Miller, MD, a former head of the FDA’s Office of Biotechnology, is to appoint a powerful, independent Agency ombudsman with the authority to impose sanctions on FDA employees responsible for flawed decisions or policies.

In Europe, several countries use ‘notifying bodies’ to approve drugs and devices. A two-pronged system under which drug companies could hire private labs to certify the results of testing for safety and efficacy … with the FDA regulating the labs and retaining authority to accept or reject their findings, might be a sensible middle of the road option.