Bid to Weaken the FDA Masquerades as Reform : Drug companies fail to sneak past the Senate . . . barely

In 1992, after consumer advocates rightly dubbed the Food and Drug Administration the “Foot Dragging Agency” for its slow approval of potentially lifesaving drugs in the treatment of AIDS and other diseases, Congress passed the Prescription Drug User Fee Act. The act won praise from consumer advocates as well as drug companies for its ingenious use of industry contributions to hire more reviewers and thus accelerate the drug approval process.

The act helped the FDA strike a sensible balance between the need for drug companies to move their drugs swiftly onto the market and the responsibility of government to ensure that those drugs are safe. Congress, however, apparently doesn’t know when to stop. Last week, legislators almost passed an FDA “reform” bill by Sen. James M. Jeffords (R-Vt.) that would have tilted the balance dramatically away from consumer protection.

Jeffords nearly persuaded senators to vote on a newly revised version of his bill without giving them time to review it or suggest changes. There had been no public hearings. Howard Metzenbaum, a former legislator who’s now president of the Consumer Federation of America, rightly pointed out that the process was thoroughly anti-democratic. “I served 19 years in the United States Senate,” said Metzenbaum, “and I don’t know of . . . any other instance . . . where you bring a bill to the floor of this major impact without knowing what’s in the bill.”

Fortunately, Jeffords’ effort failed because of scheduling conflicts. Senators, now off on a month’s recess, can consider at length a bill that they appeared to be on the verge of approving. Its anti-consumer flaws are many:

--It eliminates the rights of states to strongly label over-the-counter drugs and cosmetics. Eleven years ago, Californians passed Proposition 65, a measure requiring manufacturers to warn consumers if their cosmetics or drugs contain chemicals known to cause cancer or birth defects. The Jeffords bill’s “uniform national standards” preempt more stringent standards in California and elsewhere.

--It pushes the FDA to submit reviews of medical devices like surgical gloves and pacemakers to private, third-party reviewers. Manufacturers would pay for the reviews directly; the temptation would be strong to choose reviewers with reputations for being easy. Reviewers would be tempted to relax their standards to win repeat testing contracts.

--For the first time, it lets pharmaceutical companies send doctors mass mailings of scientific articles about the use of prescription drugs for purposes the FDA has not yet approved. But it fails to require long-term studies to determine whether the new uses are effective, or even safe. Nor does the bill enable the FDA to subpoena the documents of drug companies they suspect of withholding important safety data. Other federal departments have subpoena power, and that’s essential if the FDA is to carry out proper oversight.

When Congress was debating passage of the user fee act in 1992, one of the strongest lobbyists for liberalized FDA drug approval was the American Foundation for AIDS Research. Today, that organization’s president, Dr. Arthur Ammann, strongly opposes the Jeffords bill for its “failure to counterbalance speeded-up drug availability with long-term follow-up and basic consumer protections.” It is a measure of how far the pendulum has swung toward industry desires and away from careful oversight.

Legislators ought to remember Ammann’s opinion when they return to Washington next month and take up Jeffords’ bill.