Measure Requiring Postmarket Drug Studies Stripped From Bill

A proposal to grant the FDA authority to require postmarket studies of new prescription drugs has been pulled from an agriculture appropriations bill that funds the agency.

The proposal, introduced as an amendment to the appropriations bill by Rep. Rosa DeLauro, D-Conn., would have enabled the FDA to launch proceedings to stop the sale of certain drugs if their manufacturers failed to comply with a request for postmarket research. The amendment was removed because, according to Rep. Nathan Deal, R-Ga., the measure "sought to change existing law and constituted legislation in an appropriations bill."

In proposing her amendment, DeLauro cited a March 2006 GAO report "Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process," (PDF file: 67 pages / 790 KB. More about PDFs.) which found "FDA lacks authority to require certain studies and has resource limitations for obtaining data."

The FDA requested postmarket research for 73 percent of the drugs it approved between 1988 and 2003. But pharmaceutical companies have a poor track record of completing such trials, having yet to initiate nearly two-thirds of postmarket studies the agency has called for, according to a 2003 FDA Talk Paper.

DeLauro's amendment reflected much of the intent of the Food and Drug Administration Safety Act of 2005, S. 930 (type "S 930" in the search box after selecting "Bill Number"), which was introduced by Sen. Charles Grassley, R-Iowa. That bill would establish a Center for Postmarket Drug Evaluation and Research to track adverse health effects of drugs after they have been released for sale to the public and to act quickly to pull medications off the market, if indicated.

S. 930 has languished in the Senate Committee on Health, Education, Labor and Pensions since April 2005.