This week, the American Pharmacists Association (APhA) and eight other groups sent a letter to the chairman and ranking members of key House and Senate committees expressing concern about proposals by the Food and Drug Administration and a provision in Section 11 of the FDA and NIH Workforce Authorities Modernization Act (S. 2700) that would exempt certain biologics — including biosimilars — from USP public standards for quality, including the naming of biologic and biosimilar medicines.
Signing the letter with APhA were the Academy of Managed Care Pharmacy, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, Biosimilars Council of the Generic Pharmaceutical Association, International Academy of Compounding Pharmacists, National Alliance of State Pharmacy Associations, National Community Pharmacists Association and National Council for Prescription Drug Programs.
“Pharmacists and other practitioners rely on the monographs in the United States Pharmacopeia-National Formulary (USP-NF) to set a single standard for quality, safety and purity of medications, but also as the primary means to identify the single nonproprietary name of medications. Approaches that deviate from using a single source to identify the nonproprietary naming impact the ability of health care practitioners to clearly communicate health information and protect patients from misbranded and adulterated medications,” the coalition wrote in the Aug. 1 letter, directed to four Senate and four House committees.
“The current system establishes USP as the primary entity to develop and establish names in the United States consistent with global standards for nonproprietary naming. USP works with other stakeholders, nationally and internationally, to accomplish that objective,” the groups noted. “Divergence from this process in the United States could jeopardize the supply chain and make medications less safe.”
The FDA and NIH Workforce Authorities Modernization Act (S. 2700), introduced in mid-March, is currently before the Senate Committee on Health, Education, Labor and Pensions (HELP). The bill is sponsored by the HELP committee chairman, Sen. Lamar Alexander (R., Tenn.), and co-sponsored by the committee’s ranking member, Sen. Patty Murray (D., Wash.).
Section 11 of S. 2700 could undermine uptake of biosimilars and doctor, pharmacist and patient confidence in these medications, according to Stacie Maass, senior vice president of pharmacy practice and government affairs for APhA.
“In practice, USP’s work provides a uniform quality standard, clarity for health care practitioners and confidence for patients,” Maass explained. “Pharmacists rely on USP quality standards. Removing requirements to adhere to these standards will raise additional questions and concerns about the safety of these emerging products.”
In the letter, the coalition noted that about 20 biosimilars have been approved and marketed in Europe under an existing system of mandatory public standards and common nonproprietary names.
“Our organizations share a commitment to patient safety and, as such, we believe that biologics and biosimilars should be required to have the same nonproprietary names based on existing standards and mechanisms,” the pharmacy industry groups said in the letter. “Given the broad and negative implications of such potential naming proposals, as well as their controversial nature, we are requesting that FDA not finalize current guidance and proposals and that legislation not include these provisions.”