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News & Press: Breaking News

IACP Applauds Leadership of the U.S. House of Representatives Committee on Appropriations

Thursday, July 13, 2017   (1 Comments)
Posted by: IACP
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The International Academy of Compounding Pharmacists (IACP) on behalf of our more than 4,000 member compounding pharmacists, and the patients and prescribers we serve, applauds the leadership of the U.S. House of Representatives Committee on Appropriations as it released its Full Committee Report on the FY 2018 Agriculture Appropriations Bill on Wednesday, July 12, 2017.

 

We are so grateful to all the champions of Compounding that rose during the Full Committee Markup, and expressed support for preserving patient access for compounded medications.

 

Appropriations Resources for your Review

 

Please click here to access the complete FY18 Appropriations Report.

 

Please click here to access a FY 2018 Appropriations Full Committee Compounding Report Language Summary

 

Please click here to view video clip from the Full Committee Report on FY 2018 Agriculture

Appropriations Bill proceedings regarding compounding, July 12, 2017.

 

Please Note: The report language is meant as a way to clarify congressional intent of the laws the Food & Drug Administration (FDA) and other agencies are basing their policies on, in this case the Drug Quality and Security Act (DQSA) of 2013.

 

In this report, the Congress has clearly stated that the FDA is misinterpreting the DQSA in compounding policies and overstepping their regulatory authority, and directs the FDA to change their DQSA policies to align with statute and the congressional intent expressed in the report. However, report language does not change the law currently and should not be read in that manner.  This report language is for Fiscal Year 2018 Appropriations.

 

While not as powerful as legislation, this report language will give us a strong tool as we work with the Congress and the new administration, including Secretary Price and FDA Commissioner Gottlieb, towards FDA policies that adhere to the laws Congress writes and that protect both patient safety and patient access to critical compounded medications. 

 

IACP Remains Committed to Seeking Solutions that Maintain a Balance Between Public Safety & Patient Access to Compounded Medications

 

IACP continues to believe and support the primary mission that patient safety is of the upmost importance when discussing compounded medications. We strongly believe that proper regulation to ensure patients can access life-saving medications is an important part of this discussion. 

 

Since passage of the Drug Quality and Security Act (DQSA) in 2013, the Food & Drug Administration (FDA) has implemented and enforced the law in a way that is inconsistent with its congressional intent as has been expressed to the agency multiple times in the form of statements in the congressional record, letters from Congress, questions for the record asked in congressional hearings, directives in the reports accompanying FDA’s appropriations bills, stakeholder input, and in some cases, the plain language of the statute. FDA’s regulatory overreach has led to state licensed and compliant compounding pharmacies being inspected and otherwise treated like drug manufacturers, and more importantly, has jeopardized patient access to compounded medications. 

 

For more than three years, IACP has been working with a coalition of 30+ pharmacy and physician organizations who rely upon compounded medications to treat their patients to try to work with the FDA and the Congress on improving the agency’s compounding policies in a way that better balances public safety with patient access to critical medications. Unfortunately, despite these efforts, FDA continues to misinterpret the DQSA and assert regulatory authority over the practice of pharmacy in a way Congress never intended. Congress has, in the last two bills funding the FDA (FY16 and FY17), included report language directing the FDA to alter their policies on compounding to align with congressional intent and the language of the statute.  FDA has, to date, ignored those congressional directives and continues to substitute their desired regulatory authority over compounding for the authority given to the FDA under federal law.

 

As such, IACP is encouraged with the inclusion of the Report language within the FDA FY18 Appropriations Bill Language requests. We are confident that Congress will continue to direct FDA to act within Congressional intent as evidenced by the inclusion of these FY18 appropriations report language.  

 

On behalf of patients, physicians, pharmacists, and other healthcare providers, IACP remains committed to seeking solutions that maintain a balance between public safety and patient access to compounded medications.

 

Comments...

Mike Boehmer says...
Posted Monday, July 17, 2017
Great job IACP! Thank you for your good work.

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