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

Alexander, Senate Committee Direct FDA to Meet With Doctors, Patients, Pharmacists on Compounding Law

At Alexander’s request, Senate Appropriations Committee directs agency to start answering questions, hearing concerns about its implementation of law

Friday, May 23, 2014Liz Wolgemuth 202-228-4729

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“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak. If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.” –Lamar Alexander

Washington, D.C., May 23 – U.S. Senator Lamar Alexander (R-Tenn.) today announced that, at his request, the Senate Appropriations Committee is directing the Food and Drug Administration (FDA) to meet with doctors, patients, and pharmacists to discuss their concerns about implementation of the compounding legislation passed into law in November 2013.

The committee report for the Fiscal Year 2015 Agriculture Appropriations bill included language directing the FDA to “meet with stakeholders,” after Alexander heard from doctors, patients and pharmacists that the agency was not communicating with them or addressing their concerns about the agency’s implementation of the Compounding Quality Act.

Alexander, the senior Republican on the senate health committee, said: “The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak. If FDA isn’t sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.”

The directive to FDA was included in what is called “report language,” which accompanies legislation when it is passed out of committee. These committee reports often contain more detailed direction for departments and agencies—requiring or encouraging specific actions.

The language included in the committee’s report was: “The Committee notes that the Food and Drug Administration has begun implementing the Compounding Quality Act by releasing guidances and working to appoint members to the Pharmacy Compounding Advisory Committee.  The Committee is concerned that the Food and Drug Administration is not meeting with any stakeholders before publicly releasing further guidance for public comment.  The Committee directs the Food and Drug Administration to meet with stakeholders to help inform the implementation of the Compounding Quality Act to ensure continued access to safe compounded drugs for which there is a clinical need.‎”

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