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.
