US Senate Committee on Health, Education, Labor, & Pensions

Alexander: FDA “Off to a Fast Start” in Implementing New Law to Clarify Oversight of Compounding Pharmacies

Presses for details on agency’s next steps from FDA Commissioner, who says new compounding law is a “very, very important step forward”

Thursday, March 13, 2014Liz Wolgemuth 202-228-4729

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“Now that the legislation has established who is on the flagpole, FDA and states can take the action necessary to ensure compounded drugs are safe in the facilities that they regulate.” –Lamar Alexander

Washington, D.C., March 13 – At a Senate health committee hearing today with Food and Drug Administration Commissioner Margaret Hamburg, U.S. Senator Lamar Alexander (R-Tenn.), the committee’s Senior Republican, praised the Food and Drug Administration’s “fast start” in implementing the new law he worked to pass to help clarify oversight of compounding pharmacies.

“The FDA gets plenty of criticism, but I want to give credit where credit is due: you’ve responded to a crisis as if it were a crisis. You’re off to a fast start in implementing this important legislation and I appreciate that. Just one week after the legislation was signed into law, FDA published three guidance documents,” Alexander said.

The new law is the result of a legislative agreement Alexander helped reach between House and Senate health committees to make compounded sterile drugs safer. The law clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

Alexander said today: “It has been a little over 100 days since the president signed the Drug Quality and Security Act, and in that time 30 facilities have registered as outsourcing facilities nationwide—they’ve done that voluntarily--and these 30 facilities all have done this without receiving guidance on the requirements they’ll have to meet for the sterile drugs they make. So that’s a good sign, and I believe that once we have more clarity, the number of outsourcing facilities will go up significantly.”

Hamburg testified that the FDA is working on drafting the manufacturing guidelines that compounding facilities choosing to register with FDA will have to meet, and hoping to release them “as quickly as we can.”

FDA Commissioner Hamburg had testified to the committee in 2012 that if Congress failed to act, another crisis like the meningitis outbreak was “a matter of when, not if.”

At today’s hearing Alexander said, “While the final legislation was not as strong as the bill that passed this committee, the law will make it clear that either the FDA or the state is overseeing each compounding facility.”

The law says that large facilities compounding sterile drugs without prescriptions now have the ability to voluntarily register with the FDA as “outsourcing facilities,” committing to higher standards for sterile compounded drugs, to report adverse events, put on certain labels, and to list all the products they make with the FDA. The legislation kept state oversight of traditional pharmacies – the corner drug store – and FDA oversight over drug manufacturers.

Alexander asked Hamburg today if the law was successfully making it clear “who’s on the flagpole” for oversight of facilities. Hamburg testified that the law was a “very, very important step forward in terms of that effort and also really defining a new role for the FDA.” She testified that the voluntary registration process means that some compounders will not register with FDA.

Hamburg testified that FDA is strengthening its communication with states about the new system.

She added: “We’ve also been doing a lot of outreach with health care providers, hospital systems, etc., because we hope that they will see this—the outsourcing facility mechanism—as what is best for their patients in terms of assuring quality and regulatory oversight, and that it will become the standard of care and more and more companies will declare themselves to us and we will be able to work with them in this way.”

“That is my hope, too,” Alexander said.

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