The American Pharmacists Association (APhA), along with eight other health care organizations (Academy of Managed Care Pharmacy, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, Biosimilars Council—A Division 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) sent a letter directed to the Chairman and Ranking Member of key House and Senate committees. The letter expresses concerns about proposals by the Food and Drug Administration (FDA) and a provision included in Section 11 of the “FDA and NIH Workforce Authorities Modernization Act” (S. 2700) that would exempt certain biological products, including biosimilars, from the requirement to adhere to U.S. Pharmacopeial (USP) public standards for quality, including the naming of biologic and biosimilar medicines.
Patient safety is at the root of concerns expressed in the letter. The letter also highlighted the importance of established practices that enable health care practitioners to clearly communicate health information and protect patients from misbranded or adulterated medications.
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 collaboratively, nationally and internationally, to accomplish that objective. The letter notes that divergence from these established processes and standards in the United States could jeopardize the supply chain and make medications less safe.
Stacie Maass, BSPharm, JD, APhA Senior Vice President, Pharmacy Practice and Government Affiars, noted that Section 11 of S. 2700 could undermine biosimilar uptake and physician, pharmacist and patient confidence in them. “In practice, USP’s work provides a uniform quality standard, clarity for health care practitioners and confidence for patients.”
“Pharmacists rely on USP quality standards,” Maass added. “Removing requirements to adhere to these standards will raise additional questions and concerns about the safety of these emerging products.”
To view the letter, please click here.