Alexander: Congress Must Hold FDA Accountable

Friday, January 3, 2014

U.S. Senator Lamar Alexander, the lead Republican on the Senate health committee, Friday said that he’ll push in 2014 for an oversight hearing of the Food and Drug Administration and monitor its activities to ensure proper implementation of his legislation to help prevent another meningitis outbreak in Tennessee, which became law on Nov. 27.

“We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick,” Senator Alexander said. “Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012.”

The Drug Quality and Security Act distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy. 

The legislation is based on a proposal Senator Alexander introduced in the U.S. Senate, as well as an agreement he helped reach with the U.S. House of Representatives. It also includes provisions to track and trace the more than 4 billion prescriptions that are written every year to help ensure their safety, and provides patients with better information on compounded drugs, said officials.

In November of 2012, when the Senate Health, Education, Labor and Pensions Committee held its first hearing on the deadly meningitis outbreak, Senator Alexander called for a new model of oversight of sterile compounding pharmacies. Alexander and HELP Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) announced a legislative agreement and the bill was passed by the House on Sept. 28. The Drug Quality and Security Act cleared by both houses of Congress on Nov. 18, and the president signed it Nov. 27.

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