Almost the Right Rx

Legislation to give the FDA important new powers can do without one provision.

WHILE MOST attention this week has been focused on the Iraq supplemental appropriations bill, the Senate also has been debating far-reaching legislation to give the Food and Drug Administration a long-needed increase in its regulatory powers. A very unneeded amendment, however, is threatening the bill.

The bill would reauthorize the system of user fees that the FDA charges pharmaceutical companies and manufacturers of medical devices. Congress approved this arrangement in 1992 to speed FDA decision making and get needed drugs onto the market more efficiently. User fees account for a large portion of the FDA budget, but the agency's authority to collect them expires in September. There is broad support not only for maintaining the system but for increasing the amount of fees that the FDA can collect.

Attached to the must-pass user fees measure are a number of important enhancements to the FDA's regulatory authority and responsibilities. Under the legislation, the agency would be required to collect massive amounts of data on prescription drug use from public and private sources after drugs have been approved, to detect harmful side effects and other dangers that testing before approval might have missed. The FDA would also be able to require drug companies to alter warnings and other information on labels. And, critically, the agency would have the power to order drug trials after a drug's approval in certain cases.

All of these reforms would lead to better-informed regulators, patients and doctors. Everyone has an interest in enhancing the data available to the government and, ultimately, the public on prescription drugs after they enter the market. Compiling more evidence more quickly would help detect problems with new prescription medications faster and with greater accuracy and assist consumers in making reasoned choices about the drugs they take.

Complicating the bill's prospects for passage, however, is an amendment from Sens. Byron L. Dorgan (D-N.D.) and Olympia J. Snowe (R-Maine) that would allow the importation of prescription drugs from other countries, a proposal that supporters claim would let cut-rate pharmaceuticals flow into the United States, saving ailing Americans untold amounts of money. This is a mirage; importation will not solve the problem of drug pricing. U.S. drug firms sell prescription medications to countries such as Canada at low prices, a situation that would quickly change if Canadian distributors started to recycle large quantities of drugs back to the United States. Further, President Bush has threatened to veto the bill if it contains such language. For the sake of common sense, and to enhance the chances of urgently needed legislation, the Senate should reject the importation amendment before passing the bill.