An exciting victory in the fight for affordable immunotherapy for our patients!
On April 19, the House Appropriations Committee approved the FY 2017 appropriations bill for the Department of Agriculture. The work of the Food and Drug Administration (FDA) is funded through this bill. As part of the approval process, the Committee approves a report that accompanies the bill and provides additional direction to the agencies covered by the bill.
In the FDA section of the Committee Report, it says,
Drug Compounding of Allergen Extracts.
“The Committee is concerned that proposed changes to general chapter 797 of the USP contradicts the legislative intent … of DQSA regarding the practice of ”office-use” compounding of allergen extracts. The Committee is concerned that the proposed changes to USP general chapter 797 would be inconsistent with its legislative intent of Section 503A and with the agency’s own previous positions on the practice of office-use compounding of allergen extracts. It is the sense of the committee that the practice of office-use compounding of allergen extracts by physicians is proven to be both safe and effective for the diagnosis and treatment of allergic conditions.
The Committee suggests that the USP work with organizations from the physician and patient communities that represent physicians who regularly engage in office-use compounding of allergen extracts or patients who benefit from such compounding of allergen extracts, to ensure that any changes to USP general chapter 797 regarding office-use compounding of allergen extracts are reflective of the clear legislative intent of Section 503A…”
Allen Meadows, MD, FACAAI, chair of the Advocacy Council of ACAAI, has been working closely with his hometown Congressman, Robert Aderholt (R-AL), chairman of Agriculture Appropriations Subcommittee, to get Congress to take this stand on behalf of allergists and our patients. We appreciate Congressman Aderholt’s leadership on this issue and would also like to thank Congressman Sam Farr (D-CA), the Ranking Democrat on the Agriculture Appropriations Subcommittee, for his support of this effort. In order to get this language included in the Committee Report, it was imperative that we have bipartisan support for this initiative.
We’re hoping that this strong message from Congress reiterating the stance it took two years ago in support of physician in-office compounding of allergen extracts does not fall on deaf ears at either the FDA or USP.
We look forward to working with USP and the FDA to preserve the ability of physicians to prepare allergen extracts in-office and ensure this life-changing therapy is available to our patients.
But the fight isn’t over yet – there will be more challenges to come. Consider supporting DASH today, and join the defense for affordable allergy shots – for the future of our patients and the specialty.