House OKs bill aimed at improving drug safety

WASHINGTON (AP) - The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.

The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed.

The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.

Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.

Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.

The Senate is working on similar legislation.

"We are near the resolution of last year's deadly outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.

That panel's top Democrat, Rep. Henry Waxman of California, said, "There is no question that this bill represents a step forward."

Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies "is not strong enough to ensure the public safety."


(Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

Top Stories

  • They're Back
    Danny O'Neil says the Seahawks' defense has rediscovered its Super Bowl form

  • Holiday Map
    Find Christmas trees, Santa photos, and lights on the MyNorthwest Holiday Map
ATTENTION COMMENTERS: We've changed our comments, but want to keep you in the conversation.
Please login below with your Facebook, Twitter, Google+ or Disqus account. Existing MyNorthwest account holders will need to create a new Disqus account or use one of the social logins provided below. Thank you.
comments powered by Disqus
Sign up for breaking news e-mail alerts from MyNorthwest.com
In the community
Do you know an exceptional citizen who has impacted and inspired others?
KIRO Radio and WSECU would like to recognize six oustanding citizens this year. Nominate them to be recognized and to receive a $2,000 charitable grant.