Mikulski & Hoyer Hail Signing of Drug Safety & Medical Devices Legislation

Press Release

Mikulski & Hoyer Hail Signing of Drug Safety & Medical Devices Legislation

2,000 FDA Jobs Preserved with Timely Reauthorization

WASHINGTON, DC - Today, President Bush signed into law the Food and Drug Administration Amendments Act, legislation that will significantly enhance the FDA's ability to ensure consumers have timely access to safe prescription drugs and medical devices. The legislation, which reauthorizes the user fee programs for FDA-approved prescription drugs and medical devices through fiscal year 2012, passed the House and Senate last week after negotiators from both chambers, including Senator Barbara Mikulski (D-MD) and Congressman Steny Hoyer (D-MD), struck a bipartisan-bicameral deal to allow it to advance before the current law expires. In meeting the deadline, 2,000 FDA jobs that depended on the bill's timely renewal were preserved.

"Since we first sat down to draft this legislation in the Senate HELP Committee, I have been looking out for the hard working scientists at the FDA. Congressman Hoyer and I knew that 2,000 FDA jobs could be at risk if Congress did not pass this bill by September 30, 2007, and we worked to ensure this would not happen," said Senator Mikulski, a member of the Senate Health, Education, Labor and Pensions (HELP) Committee. "I have fought for years for the right facilities and the right resources for the FDA, and I will continue to fight for the employees at the FDA."

"Senator Mikulski and I are pleased we were able to help resolve the issues that were holding up this important legislation," said Rep. Hoyer. "These programs and the FDA employees who administer them are critical to the delivery of safe drugs and medical devices to patients and consumers. The new provisions approved in the legislation will no doubt save lives by improving the process for ensuring drug safety and granting the FDA new authority to protect consumers after drugs are on the market."

New measures approved in the legislation take significant steps to strengthen FDA's ability to ensure drug safety before and after drugs are on the market. Chief among these are giving FDA the authority - for the first time - to require a drug company to make a change to a drug's label post-approval. One of the primary gaps in FDA's current authority is its inability to require a drug company to add new warnings to its label to reflect new safety information discovered after approval. The case of Vioxx is a tragic illustration of this situation. When FDA first learned of study results suggesting serious cardiac risks, FDA haggled with the company for 14 months before consumers finally saw a watered-down warning.

The timely passage of the legislation also preserved the positions of 2,000 FDA employees who were notified by the Bush Administration that layoffs would be imminent if the user fee programs were not reauthorized by Congress by September 30, 2007.

Source