Saturday, January 4, 2014

Alexander plans to keep tabs on FDA work with compounding pharmacies

U.S. Sen. Lamar Alexander wants to monitor how well the U.S. Food and Drug Administration is using a new law passed by Congress to prevent another fungal meningitis outbreak.

He said today that he will push for an oversight hearing on the agency’s regulation of compounding pharmacies. FDA Commissioner Margaret Hamburg has said the law does not give her agency all the powers it would have liked, but that it was a step forward in defining regulatory authority. Members of Congress criticized her agency for failing to do its job when a contaminated steroid made by Massachusetts-based New England Compounding Center caused an outbreak that sicked 751 people with 64 deaths.

Tennessee has been one of the hardest hit states.

“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,” 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.”

One criticism of the law is that it allows compounders to voluntarily register with the FDA as “outsourcing facilities” and become subject to the same rules and regulations as drug manufacturers. Compounders who do not register will continue to be regulated by state boards of pharmacy. The law also sets up a framework that will eventually allow for better tracking of drugs.

The Drug Quality and Security Act was signed into law by President Obama on Nov. 27. Alexander worked with members of the U.S. House of Representatives to come up with compromise legislation.

No comments:

Post a Comment