US Senate FDA Reform Bill Developments

A bill to allow doctors access to peer-reviewed clinical data for as-yet-unapproved uses of prescription drugs has been rolled into Senator Nancy Kassebaum's US Food and Drug Administration reform bill. The proposal, originally sponsored by Senator Connie Mack, would allow drug companies to give doctors studies published in medical journals or presented at accredited education programs, as long as they clearly state the drug is not FDA-approved.

Meantime, there is strong bipartisan support for commonsense FDA reform, one source told the Marketletter; to include speedier approvals and expedited access to drugs for the terminally ill. However, last week some Republicans managed to put the bill on hold, after fierce lobbying from insurance companies. They object to a provision allowing individual policies to be written for those who lose their jobs or change to a job that does not offer insurance cover. This would, said John Troy, executive director of the Health Insurance Association of America, be very expensive for both the industry and individuals. States are already experimenting with the concept and should be left to do it, he said, rather than making federal law.

Labor Committee chairman Sen Kassebaum is determined to get the bill passed before she leaves the Senate at year-end. Without this provision a major part of the reform thrust is lost, she noted, and if it cannot be brought to the floor as it stands, she will look for other bills to which it can be attached. While it "does not strike out in a bold new direction," she said, "it is a very positive step forward that will help reduce barriers to health coverage for millions of working Americans."