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Senate Approves "CR/omnibus" Legislation to Fund the U.S. Government Through September 2015
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Late on Saturday, December 13th, the Senate approved the "CR/Omnibus" legislation to fund the U.S. Government through September of next year. This was the legislation passed last week by the House before they adjourned with some last minute scrambling regarding Obama nominees and attempts by some legislators to limit funding to the Department of Homeland Security.

When the House bill passed, it retained as part of the accompanying report language (H Rpt 113-468) instructions to the FDA which IACP had lobbied for as part of our 2014 Compounders on Capitol Hill event back in May. That language appears as follows:

 

House Report Language - Page 55
Pharmacy Compounding.—The Committee provides an increase
of $12,000,000 for pharmacy compounding activities specified in the
Drug Quality and Security Act (DQSA). The Committee urges FDA
to complete inspections of compounding facilities that clearly fall
within the agency’s jurisdiction and take all necessary enforcement
actions needed to promote the safety of the drug supply chain. For
those pharmacies unaffected by DQSA, state boards of pharmacy
are the proper regulator of state licensed pharmacies and should
remain so. The Committee will continue to monitor FDA spending
and oversight over compounding pharmacies to ensure the intent
of both funding and legislation approved by Congress is observed.

In addition to the language contained in the House Report, there is an accompanying Senate Report (113-164) which has additional instructions. IACP is carefully reviewing this report to ensure the original requests from IACP are still there; however, based on conversations with Senate staff last week, nothing had been removed or changed. IACP will keep you posted on any updates here.

Additionally, there is a "Congressional Directive" that includes additional information over-and-above the individual reports from both Houses relevant to compounding and FDA oversight. This was added on Saturday when the bill was under consideration based upon the Fix DQSA Coalition's conversations with House and Senate staffers in which we raised concerns that the agency is issuing guidance documents with limited input from organizations like ours.

 

Congressional Directives - Page 32
During the past year, FDA has informed non-governmental stakeholders of important
decisions and announcements before they informed the Committees. A collaborative working
relationship between the Committees and agency is necessary to ensure efficient and effective
implementation of Congress's funding decisions. These actions jeopardized this relationship.
As such, FDA is directed to ensure the Committees are notified of major changes to existing
policies and any significant developments in its operations prior to providing non-governmental
stakeholders such information.

 

So… we now have clear instructions provided to the FDA regarding how DQSA and compounding oversight is to be managed in the coming year. That provides us with strong rationale to take to Congress any example of the agency's continued attempts to thwart Congressional intent!

 

IACP will keep you apprised of developments.

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