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Article in L.A. Times on Proposed Bills Limiting FDA Review of Drugs

This commentary, by Health Research Group Director Sidney Wolfe, M.D., appeared in the Los Angeles Times on July 12, 1996.

For 25 years, Public Citizen’s a Health Research Group has worked to protect the health of Americans, with much of its efforts directed at the Food and Drug Administration. The group has been instrumental in getting Oraflex (an arthritis drug) and phenformin (a diabetes drug) banned and has petitioned the FDA to require warning labels on dangerous products and to uphold its legal obligations by protecting the public on products such as food dyes and unpasteurized milk. Indeed, we have often been perceived as the FDA’s harshest critic. Now, however, we find ourselves defending the agency.

At no time during the last 25 years has there been a graver threat to American health than the current legislative assault on the FDA. Proposed legislation in the House and Senate would decimate the system that has made FDA approval of drugs the gold standard throughout the world.

Before 1962, the FDA was not significantly different from its European counterparts in terms of making mistakes, allowing ineffective drugs on the market and finding that many products it had approved were killing and injuring people.

In 1962, Congress required that manufacturers prove new drugs to be effective as well as safe, usually through two or three , well-controlled clinical studies.

The effectiveness standard is what distinguishes the United States from other countries. Between 1970 and 1992, the U.S. approved only nine drugs that it later banned due to safety concerns. During the same period, France approved and then withdrew approval for 31 drugs, Germany for 30 and Britain for 23. None was an important break-through drug; they were aspirin substitutes and other “me-too” drugs.

In the past few years, the FDA improved its record on the rate of evaluation of important drugs by giving priority to applications that present potentially important advancements-for example, drugs for AIDS and cancer-over review of applications for “me-too” drugs. So when industry-inspired critics complain of the U.S. lagging behind other countries in terms of new product approvals, they are really talking about arthritis or headache pills, not drugs that would have a more important impact.

A primary goal of the proposed legislation seems to be to expedite the approval of “me-too” drugs. But the bills would meet that goal by sacrificing rigorous review for effectiveness and safety-a dangerous trade-off. For example, under the bills, the FDA could waive the requirement of well-controlled clinical investigations, thereby creating a situation where the risks of new drugs are measured against undetermined benefits. Further, the FDA could not consider relative effectiveness when evaluating a drug. Thus, if data showed that a product undergoing review was as safe as but less effective than an existing product, the FDA could not deny approval. Inevitably, second-rate drugs would enter the American market. The House bill also attacks another important consumer protection. Under current law, the FDA approves products only for specific uses.

The House bill would allow companies to promote products for uses that have never been approved. A company could also seek approval of an additional use based on evidence that the use already was common among doctors and “represents reasonable clinical practice.’. The cancer-causing drug DES offers a good example of the danger posed by both these provisions. In the 1960s, many doctors prescribed DES, a drug approved to treat symptoms of menopause, for the unapproved use of preventing miscarriages. The great number of injuries to the women and birth defects in their babies would have been dramatically higher had the manufacturer of DES been allowed to promote DES for that unapproved use, or had DES been approved for that use based on a common practice that proved to be neither safe nor effective.

The quality of drugs would be further threatened by the proposed privatization of FDA functions. Under the bills’ provisions, an application to market a new product could be reviewed by either the FDA or a private review company. But private reviews are fraught with conflicts of interest. For example, private, for-profit reviewers who make a living from product reviews would have an incentive to grant approvals to get more business from manufacturers.

Pending legislation would make changes similar to all of the above proposals in the law for medical devices, including heart valves, bone screws and hearing aids. Not only do the bills propose to weaken the FDA’s substantive standards, they also threaten to tie the agency in bureaucratic knots by adding cumbersome paperwork and review procedures. In addition, the Senate proposal has a provision that might be manipulated by drug manufacturers to immunize themselves from liability to patients injured by nonprescription drugs.

The passage of these bills would be a dangerous step backward for American health and safety. {C}