Case Studies

Food and Drug Administration Amendments Act of 2007

422 pages – 1 hour (available before debate)

In September 2007, the House and Senate hurried through consideration a 422-page bill, the Food and Drugs Administration Amendments Act, meant in part to respond to widespread concerns about unsafe drugs and medical devices making their way into the marketplace. The rush had more than a little to do with the fact that the user fee programs that fund safety reviews at the Food and Drug Administration (FDA) were about to expire at the end of the month. Without that funding, the agency would be hamstrung.

On the House floor, Rep. Frank Pallone of New Jersey described the quick action as a rescue mission. An earlier version of the legislation, he said, had been languishing because of a breakdown in negotiations between the House and Senate. Now, however, he said everybody was behind the new version, H.R. 3580, introduced that very day, and the Senate had agreed to approve it by unanimous consent.

“Mr. Speaker, most of us are too young to remember, but in the early days of the movies there was a series of movies based on the “Perils of Pauline,” he said on the House floor. “Pauline was a heroine who always got tied to the railroad track, and just as the train was bearing down on her the hero would come out and rescue her for another adventure in the next movie reel…. [W]e’re going to rescue Pauline and pass the [law]…and lots of good things are going to happen.”

While the new law made some changes to strengthen the drug and medical device safety system, it lacked many of the provisions for which safety advocates had argued. For example, a coalition of groups, including Center for Science in the Public Interest, Consumers Union, National Research Center for Women & Families and the National Women’s Health Network, had called for a two-year moratorium on direct-to-consumer ads for new drugs—those ubiquitous magazine advertisements for the latest drug to cure depression, reflux and other common ailments. In 2004, Merck recalled Vioxx, an arthritis drug made popular by aggressive ad campaigns, because of concerns about increased risk of heart attack and stroke by long-term users. In addition, the law’s new provisions on medical devices had not been publicly reviewed or debated in a Senate hearing.

On September 19, the same day it was introduced, the House voted 405 to 7 to pass the bill. The Senate approved it the following day by unanimous consent, and the president signed it a week later.

Since the passage of the law, news reports show new concerns about the FDA’s safety record. A new report from the U.S. General Accounting Office (GAO) criticizes the agency [pdf] for letting medical devices on to the market without adequately reviewing their safety. And a group of nine agency scientists has come forward and blown the whistle on lax agency practices in reviewing devices. For example, they charged that agency higher ups overruled scientist to improve the sale of an imaging device for breast cancer after receiving a phone call from a then-Connecticut congressman, Rep. Christopher Shays.

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