The Food and Drug Administration has been without a head since President Bushs inauguration last year. In choosing a new FDA chief, the White House and Congress should recognize one important fact: the policies of the FDA have reduced the health and welfare of Americans.
The FDA has power over what new drugs and medical devices can be sold in the United States. Congress gave the FDA this power to make sure that only safe and effective drugs come onto the market. Sounds good in theory.
In practice, bureaucracy and skewed incentives have meant that in trying to prevent some bad drugs, the FDA has prevented or delayed many more good drugs from reaching Americans.
The FDA can make two kinds of mistakes: It can permit a bad drug, and it can fail to permit a good drug. When it permits a drug that turns out to be bad, it is pilloried. But when the FDA refrains from permitting a drug that would have done much good, it usually suffers little criticism.
In a way, the problem lies with the public and the media. When little Tommy from Saginaw, Michigan, becomes gravely ill due to the side effects of a new drug, television reporters show the poor lad languishing in a hospital bed. Viewers see and share in the suffering. And when little Tommy dies, blame falls on the FDA officials who approved the unsafe drug. Shouldnt they have known better? Why didnt they do their jobs?
But if little Tommy suffers from a disease that could be cured by a drug not yet permitted by the FDA, it is unlikely that Tommys parents or doctors would even be aware of that fact. When little Tommy dies because a drug is not available, no reporters are present. His death is quietly regarded as an unavoidable tragedy.
If anyone knows of new therapies awaiting the FDAs permission and asks whether Tommy might have been saved, the FDAs response is that such therapies are experimental and unproven. And thats that.
As a result of these incentives, FDA officials are very concerned that people might die from unsafe FDA-permitted drugs but are much less concerned that people will die from lack of effective therapies.
The problem is not only that drugs are delayed. Drugs are sometimes entirely lost.
The Tufts Center for the Study of Drug Development reports that the average cost of researching, developing and getting a new drug permitted is now $800 million. Much of the cost is due to the clinical trials required by the FDA. To be sure, the trials are not without value. But the FDA does not weigh the gains of requiring additional testing against the losses of drugs that go undeveloped because high costs make such drugs unprofitable.
The massive cost of getting drugs permitted is one of the most pressing problems of U.S. health policy.
The new head of the FDA should seriously consider two reforms (other reform proposals are offered at our website: FDAReview.org).
First, the FDA should permit any drug that has gained permission from the FDAs counterpart in other advanced countries. If a drug is permitted in the European Union, for example, then within 90 days it should automatically be permitted by the FDA in the United States.
Historically, such countries have permitted drugs faster than in the United States with few adverse and many good consequences.
Second, in recent years the FDA has increasingly allowed manufacturers to make health claims about herbs, vitamins and other nutrients so long as they make clear that such claims have not been evaluated by the Food and Drug Administration. (Check your box of Melatonin, St. Johns Wort, or Ginkgo Biloba.) This trend should continue: The FDA should allow more drugs onto the market and drug makers should be allowed greater freedom of speech in labeling and advertising, provided that they make it clear whether health claims are or are not approved by the FDA.
(Unfortunately, at least one of Bushs potential FDA nominees, Alastair Wood, has indicated that he thinks less freedom of speech is needed a troubling sign for American patients.)
The FDA can assist patients, doctors, pharmacists, hospitals and other health organizations by being a trusted advisor and evaluator of medical drugs and devices. The FDAs goal should be to inform patients rather than to dictate and constrain their choices.
Informing patients treats them with fairness and respectand is a better policy than paternalism, both ethically and medically.