Perilous Rush by the FDA

In the 1990s, Congress passed two bills that essentially struck this bargain with pharmaceutical companies: If you agree to pay “user fees” that subsidize about half of the Food and Drug Administration’s drug-approval budget, we will require the FDA to halve the time it takes to approve new drugs for “serious or life-threatening” illnesses.

The deal was promptly hailed as an exemplar of Al Gore’s “Reinventing Government” scheme to save taxpayer dollars. It was welcomed by advocates for people with AIDS and other life-threatening diseases, who rightly observed that bureaucratic red tape was keeping promising new drugs off pharmacists’ shelves.

However, a two-year investigation by Times staff writer David Willman shows that the FDA has implemented the so-called fast-track legislation in a slipshod way that endangers the public. Conflicts of interest have run rampant, and poorly tested, potentially dangerous drugs have entered the market even when there is no evidence that they are superior to older, safer medications.

In just the last three years, the FDA has overseen the withdrawal of seven drugs allowed onto the market since the first faster-approval law was enacted--pills associated with countless serious illnesses and hundreds of deaths. The true number of people harmed by the accelerated drug approvals is unknown because the FDA does not even require doctors and hospitals to notify it when a drug causes serious, life-threatening “adverse events.” Legislators’ proposals to require such reporting have run into fierce resistance from hospitals and doctors, who fear legal liability.

In September, FDA and drug company officials quietly began meeting to revise the 1990s legislation, which would otherwise expire during the coming Bush administration.

FDA officials have proposed small reforms like eliminating a rule that essentially allows drug company officials to breathe down researchers’ necks at every step of the drug approval process. However, this barely touches the problem.

More fundamental reforms may be hard-fought. President-elect George W. Bush spoke during the campaign of freeing the pharmaceutical industry--a major contributor to his campaign--from government regulations that “stifle creativity.” But the 1990s legislation will require renewal in a few years, and Congress should at least press him to remedy the most glaring problems.

In the short term, outgoing FDA Administrator Jane E. Henney should require drug companies to actually complete the safety studies they promise to conduct after a drug is approved and goes on the market. The agency has never used its authority to withdraw drugs from the market if such “post-marketing studies” are not “completed with due diligence,” and FDA officials admit that they don’t even know how often such safety studies are performed.

Henney should also use her authority to restrict accelerated drug approvals to medications for life-threatening disorders. Current rules allowing such approvals for drugs treating “serious” disorders have been stretched to absurdity. Poorly tested drugs are being sold to consumers for conditions like heartburn, although existing medications are clearly safer.

FDA officials spent much of the late 1990s blaming the harmful effects of medications not on lax regulation but on dosing errors by doctors who failed to read hundreds of lines of fine print on warning labels. That has always been a flimsy excuse, given that the warning labels distributed to doctors often fail to reflect the dangers identified by the FDA’s own medical reviewers.

In a recent interview by Willman, the FDA’s drug-review director, Janet Woodcock, adopted a more sympathetic line toward doctors, reasoning that “as medical practice has changed . . . it’s just much more difficult for [doctors] to manage” the plethora of new drugs. Woodcock went on to observe that doctors “rely upon us much more to make sure the drugs are safe.”

The FDA was created in 1938 to ensure that drugs are safe and effective, with a therapeutic benefit that outweighs any risks. Woodcock’s belated and grudging recognition of that central purpose is but one of many signs that the agency has lost direction and needs guidance from Congress and Bush.