Congress has lost a stunning opportunity to reform the Food and Drug Administration. The authorization for the agency’s critical “user fees,” paid by regulated industries to help the FDA expedite the approval of new medicines, expired on Oct.1. The need for another five-year reauthorization provided a strong incentive for the Clinton administration to accept meaningful reforms. Characteristically, however, Congress settled for a half-baked compromise dictated by the FDA and by Democratic defenders of expansive federal regulation.
FDA reforms are long overdue. Physicians routinely report that the FDA’s policies actually threaten the well-being of their patients. In large part this is because the U.S. drug-approval system is significantly slower, more costly and more intrusive than that of other industrialized nations. Seventy-three percent of drugs approved by the FDA during 1987-93 had already been approved abroad. The average time required to take a drug from research lab to patient’s bedside has more than doubled since 1964, from 6.5 to 14.8 years.
Nevertheless, the FDA has constantly sought out new mandates and promulgated new requirements, regardless of the costs to patients and the regulated industry. Between 1990 and 1993 alone, the FDA pushed the average cost of bringing a new drug to market from $359 million to more than $500 million, by far the highest price tag in the world.
The new legislation, with similar House and Senate versions being reconciled, approaches FDA reform in several inconsequential ways:
– It changes the FDA’s mission, adding the obligation to “promptly and efficiently review clinical research” and make decisions “in a manner that does not unduly impede innovation or product availability.” What naivete to think that this largely symbolic language will have any impact on a 30-year tradition of risk-aversion and foot-dragging!
– It calls upon the FDA to develop a plan by year 2000 for clearing the legendary backlog of products awaiting approval. With this provision, Congress has made itself a hostage to an endless series of demands for additional resources the agency will claim are essential for meeting the required goal.
– It permits the FDA to approve a drug for marketing on the basis of a single clinical trial, where previous statutory language referred to “trials,” plural. That is largely symbolic. The FDA could easily have made a case for approval on the basis of a single, definitive trial under the previous language. The point is moot; the average number of trials performed to support approval of a new drug is currently more than 40!
– It codifies many policies that are already in place, adding nothing to the status quo but giving the impression of a lengthy list of improvements.
The single most important provision in the legislation offers drug companies greater latitude in supplying scientifically sound information to doctors about drugs “off-label” uses (those not yet approved by the FDA). Companies are currently prohibited from distributing such critical information. But even this improvement comes at a high price: substantial additional paperwork to convince the FDA that formal applications for approval of the new uses are forthcoming.
Another useful provision (found currently only in the House version of the bill) permits manufacturers to submit “health care economic information,” such as data on a drug’s cost-effectiveness, to hospitals and HMOs.
The bill contains other minor improvements, such as loosened restrictions on health claims for food products and expanded use of third parties, including academic institutions, to review medical devices.
One sneaky provision actually increases the scope of the FDA’s regulation by expanding the agency’s jurisdiction over activities that occur completely within a single state. For the first time, the FDA would have regulatory authority over small-scale research by an academic or practicing physician testing an innovative therapy.
What is most worrisome about the legislation is what it fails to include. Many critical reforms repeatedly recommended by panels of experts are conspicuously absent. There is no mention of a broadly supported and viable alternative to FDA’s current, burdensome oversight system for early clinical trials. As in the United Kingdom, approval authority could be delegated to expert, local review committees which already vet clinical trials under way at their research institutions. This single, pivotal change would significantly reduce the time and costs involved in clinical trials, particularly for smaller companies.
Neither does the bill include a binding reciprocity provision which could, for example, limit FDA review of a new drug to a maximum of, say, 60 days after its approval in the United Kingdom or by the European Medicines Evaluation Agency. THe FDA would then have to show why the drug should not be marketed in the United States, or it would automatically be approved.
Much of the blame for the failure of any meaningful reform effort belongs to House Commerce Committee Chairman Thomas Bliley (R-Va.), who represents Virginia’s tobacco-growing region nad is considered by many to be the tobacco industry’s most potent lobbyist in Washington. Bliley has trod lightly in approaching FDA reform in return for the agency’s returning the favor on tobacco regulation.
All of this means the costs of drug development will continue to rise, fewer drugs will be developed and market competition will erode. Patients will suffer high prices and benefit from fewer breakthrough drugs. These are the effects of Congress’ poltroonery.
