Concerned about a serious slowdown in the marketing of important new drugs, the FDA last month announced several measures intended to spur medical innovation. The focus is on reducing the time it takes the industry to research and develop new drugs and medical devices, primarily (according to the FDA’s press release) by providing “clearer up-to-date guidance for particular diseases and for emerging new technologies.”
But the solutions proposed by FDA commissioner Mark McClellan — who has been on the job for less than six months — do not target the real problem. The real problem is that the American public are victims of an overly risk-averse regulatory system that favors delay, rewards excessive zeal, inhibits innovation, and denies life-saving products to people who need them.
The agency’s press release on the initiative is instructive in several ways. Heavier on public relations than on public health, it carries endorsements from senior officials at the NIH, including the director. But the NIH is a sibling to the FDA in the Department of Health and Human Services, so such an endorsement is meaningless and even smacks of desperation — like using your mother as a job reference.
More important, the press release promises that in order “[t]o promote the availability of novel treatments for such important diseases as diabetes and obesity, FDA expects to create working groups that would draw experts from across the agency and from the broader community to create guidance for dealing with specific diseases.” How ironic that the FDA singles out diabetes and obesity, for these are areas in which its performance has been particularly egregious — and not because the industry needs guidance. If anyone needs guidance, it’s the FDA officials themselves.
Let me give an example from my own experience. I headed the FDA group that was reviewing the application for marketing approval for human insulin to treat diabetics, the first drug made with gene-splicing techniques. My team was ready to recommend approval after only four months of deliberation, at a time when the average time for FDA review was more than two and a half years. With typically bureaucratic logic, my supervisor refused to sign off on the approval — even though he agreed that the data provided compelling evidence of the drug’s safety and effectiveness. “If anything goes wrong,” he remonstrated, “think how bad it will look that we approved the drug so quickly.” (When the supervisor went on vacation, I convinced his boss to sign off on the approval.)
Characteristically, the supervisor was more concerned with “cover,” in case of an unforeseen mishap, than with getting an important new drug to patients who needed it. This is not the way the system is supposed to operate.
A similar ethos appears to be responsible for the agency’s reprehensible treatment of the fat substitute, Olestra. Even as government public-health officials are telling us to eat less and exercise more — in order to combat the nation’s worsening epidemic of obesity, which now kills 300,000 people a year — they are also restricting an excellent tool for controlling the intake of fat and calories. In 1996, following an eight-year review, the FDA approved Olestra, a cooking oil that adds no fat or calories to food. (Olestra is a molecule of table sugar covalently linked to soybean or cottonseed oil, and is too large for the body to absorb or digest.) But they only allowed its use in chips, crackers, and other ‘’savory snacks,” though Olestra can also be used instead of margarine, lard, butter, and oils in frying, baking, and sautéing. Moreover, Olestra is the most-tested food substance in history, having been subjected to far more trials than most prescription drugs.
Not only has the FDA rejected overtures for wider use of the fat substitute, but the agency continues to require labels on foods containing Olestra warning of possible gastrointestinal symptoms — even though the data show these are no more common than with conventional foods, and the FDA has repeatedly promised to terminate the labeling.
What’s going on here? Don’t the regulators care about public health?
The short answer is that the system they work in is biased against innovation. A regulator can commit an error by permitting something bad to happen (approving a harmful product), or by preventing something good from becoming available (delaying or denying approval of a beneficial product). Both outcomes are bad for the public, but the consequences for the regulator are very different. The first kind of error is highly visible, and the regulators are attacked by the media and by patient groups and investigated by politicians. But the second kind of error — keeping a potentially important product out of consumers’ hands — is usually a non-event.
The bottom line is that regulators make decisions defensively — in order to avoid approvals of harmful products at any cost — and so they tend to delay or reject new products of all sorts, from fat substitutes to cancer drugs and painkillers. It’s in their own interests (namely, keeping low and out of trouble — what one FDA commissioner called “periscope depth”) for regulators to be cavalier toward public health and preemptive of consumers’ freedom to choose. Meanwhile, Americans are, literally, dying for more efficient and accountable food and drug regulation.
None of this is new. More than 100 studies, inquiries, and congressional hearings have documented the negative effects of the current system. According to a report from the Tufts Center for the Study of Drug Development, “the regulatory activities of the FDA may constitute the most thoroughly investigated and studied program of government regulation in history.” Between 1982 and 1992 alone, the activities and policies of the FDA were the subject of nine major reports or sets of recommendations from government sources and independent commissions. Their recommendations for reform now sit, gathering dust, on government-issued shelves.
What we need is not more bureaucratic gobbledygook — or timid tinkering with the present system — but a fundamental reform of the FDA’s culture of risk-aversion.
— Henry I. Miller, a physician, is a fellow at the Hoover Institution and the author of To America’s Health: A Proposal to Reform the FDA. He was an FDA official from 1979-1994.