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Breaking News: HELP Senate Committee Holds FDA Hearing 3.14.14
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Health, Education, Labor and Pensions (HELP) Senate Committee Holds Hearing on FDA's Initiatives and Priorities

 

On Thursday March 13, 2014, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a Full Committee hearing entitled, Protecting the Public Health:  Examining FDA’s Initiatives and Priorities. FDA Commissioner Margaret A. Hamburg, MD, was called to testify in order to provide a broad summary of FDA implementation on all the most recently passed legislation by the HELP committee that falls within FDA jurisdiction. Thus, the topics of discussion included a broad range of topics such as food safety, drug shortages, and compounding. It should also be noticed that the hearing followed days after the President released his 2015 Budget which included a request for $25 million for FDA to specifically use toward compounding and detailed the usage of the funds for future inspections, compounding oversight, and implementation of the DQSA.

During the hearing Senators of the HELP Committee addressed the Drug Quality and Security Act (DQSA).  Specifically, Senator Alexander stated during his opening statement that he is very pleased that passage of compounding legislation has occurred and the DQSA has finally concluded “who is on the flagpole." However, he expressed concern with the FDA’s lack of timelines for providing future guidance, the methods in which FDA is coordinating with States, and FDA’s follow-up to its most recently sent warning letters. Senator Alexander concluded by stating that while he has some concerns, he overall commends FDA on the quick start of the implementation of the DQSA.

During the Question and Answer portion of the hearing, Senator Alexander asked Commissioner Hamburg as to whether she has heard about cases where States are attempting to regulate pharmacies that register as outsourcing facilities (OFs). Commissioner Hamburg responded that while she hasn’t heard of any specific instances where States are attempting to require additional oversight on OFs, States vary in terms of laws and oversight and the recently passed law only provides a voluntary registration which provides an opportunity for confusion. To her response, Senator Alexander clarified that “the OFs are all yours, but the other compounding pharmacies belong to the States.”  

As far as when guidance is coming for the OFs, Commissioner Hamburg responded that FDA is currently working on cGMPs for those OFs and will have those out to the public as soon as possible. Senator Franken followed-up to Senator Alexander’s question by asking the Commissioner what the FDA’s next steps would be in implementing the DQSA. Along with the development of the cGMPs that the Commissioner stated above in response to Senator Alexander’s question, she stated that FDA is now collecting registration from OFs and will continue inspections across the country while working on guidance that should be released soon.

Click here to view Dr. Hamburg's full testimony. Her comments on the DQSA begins on page 22 of her testimony including a more in-depth statement on FDA’s expected future actions toward compounding pharmacies. New problems continue to be identified at compounding pharmacies across the country, and FDA intends to continue its inspection and enforcement efforts to address these problems using currently available resources. FDA intends to continue proactive and for-cause inspections of compounding pharmacies and plans to take action, including enforcement actions, as appropriate to protect the public health.

Click here to view the Senate hearing video in its entirety. For more information, please email iacpinfo@iacprx.org.

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