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FDA Budget Request Slashed… But On Hold
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FDA Budget Request Slashed… But On Hold

As previously reported, the FDA requested $25 million in the 2015 budget to “enhance compounding oversight activities in FY2015.” Due to the fact that the registration by outsourcing facilities (OFs)  -- a new registration type included in the Drug Quality & Security Act -- is not mandatory, FDA protests in its budget request that it cannot rely upon the fees that OFs might provide. In addition, the DQSA specifically states that fees obtained through the registration of OFs may only be used to oversee OFs. FDA is not supposed to use these funds to oversee compounding pharmacies that do not choose to register with FDA as an OF. Not satisfied with an extra $25 million, the FDA Office of Regulatory Affairs also asked for almost $7 million in additional funding for field activities including “conducting additional inspections of high-risk human drug compounding pharmacies including sterile compounding facilities that seek to qualify for the exemptions under section 503A and facilities that register as OFs under section 503B.”

This is completely unacceptable. The intent behind the DQSA was to draw a clear line between those compounding pharmacies overseen by the individual state Boards of Pharmacy and outsourcing facilities overseen by the FDA. IACP’s leadership targeted this “money grab” as a top priority for protecting our members. Beginning in early March, language that  reduces and restricts appropriations money for the FDA was taken by your IACP staff to House and Senate offices seeking their support.

That was successful! The House not only cut the FDA request in half, it also took the unusual step of including report language that prohibits the FDA from using that money or any other budget money they may have or receive to take regulatory action against traditional compounders. The Senate also included language expressing its disappointment in FDA's implementation of the DQSA and stating that implementation should not continue until FDA has sought input from stakeholders and worked closely with pharmacists. The current appropriations bill moving forward from House and the Senate keeps that IACP language intact.
The loss in this week’s primary House Majority Leader Eric Cantor (R-VA)  in a surprising upset coupled with the administration’s efforts to deal with the growing Veterans Administration scandal has thrown all the schedules out the window.  While IACP believes the Senate appropriations bill will move to a full vote next week, the change in leadership, concerns about Iraq, mid-term elections, and the VA issue may delay House appropriations work until later this summer.

IACP’s lobbying and policy team will be monitoring both the Senate and House very carefully to retain that critical appropriations language.

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