Law BY JOEY BERLIN
Compounding a problem?
ALLERGISTS SAY PROPOSED STANDARDS WOULD SEVERELY CURB ACCESS TO ALLERGEN IMMUNOTHERAPY
A
llergist-immunologists say a United States Pharmacopoeia (USP) pro- posal will mess with an allergy treatment system that’s worked for more than a century. And at least one Texas allergist says the changes USP is
proposing may serve to downscale his operation. “We’d definitely have to scale back our practice quite a bit,” says allergist- immunologist Robert Ramirez, MD. “We have two offices in San Antonio, and we may have to bring that down to one.” In late September 2015, USP, which sets the Food and Drug Administration-
recognized standards for human compounding pharmaceuticals, posted pro- posed revisions to its standards for sterile compounding of allergen extracts. The revisions, which later appeared for public comment in the November- December issue of the U.S. Pharmacopeial Forum, sent allergists scrambling to voice their objections because some didn’t even hear about the proposal until just weeks before the public comment period expired on Jan. 31. The revised standards, if adopted, would remove a key exemption separat-
ing allergen extract preparations from the stricter requirements of other com- pounds. Immunologists say the exemption has allowed them to compound al- lergen extracts in their own offices, and they’ve done so safely and effectively millions of times a year. Texas allergists and national immunology groups say under the USP’s pro-
posed revisions, the required compound expiration dates, environmental con- trols, and sampling and testing requirements will make allergen immunotherapy in a physician’s office virtually impossible. Several associations, including the American Academy of Allergy, Asthma & Immunology (AAAAI) and the Ameri- can College of Allergy, Asthma & Immunology (ACAAI), have weighed in with sharp objections to the proposal, adding patient access will suffer greatly. “Actually, the proposed changes do all of the things to lower the value of
health care,” said Austin allergist-immunologist Alexander Alvarez, MD. “It limits access to needed and efficacious care, increases cost, introduces risk to the patient, and provides no benefit to the health care system in relation to al- lergen immunotherapy.” In a letter to USP (tma.tips/TMACommentsUSP), the Texas Medical Associa-
tion recommends USP keep its standards for allergen extract preparation, which allow physicians to safely compound allergen extracts in their offices.
STRICTER STANDARDS The exemption for allergen extracts from USP standards for other compounded sterile products has been in place since 2008. Essentially, as long as allergists
May 2016 TEXAS MEDICINE 63
“The proposed changes do all of the things to lower the value of health care.”
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