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FDA and USP take sides in debate on biologic drug standards.
A bipartisan effort by the Senate Health, Education, Labor and Pensions (HELP) committee designed to lower healthcare and medication costs has led to a contentious debate between FDA and standards-setting organization, the US Pharmacopeial Convention (USP). The committee voted 20–3 on June 26, 2019 to advance legislation with proposals that include changes to patent policy, ending “surprises” in medical bills, increasing transparency in healthcare, and reducing roadblocks that delay generic drugs and biosimilars getting to market (1).
It is provisions in Section 207-designated as promoting biological drug innovation-that are proving controversial, pitting FDA and USP in an exchange of policy statements. According to HELP committee documents, Section 207 is intended to prevent delays in the licensure of biosimilar and interchangeable products by excluding biological products subject to regulation under the Public Health Service Act from requirements to follow United States Pharmacopeia compendial standards. A similar provision to make biologics exempt from meeting USP standards was removed from the final 21st Century Cures Act of 2016 (2).
“A biological product is so inherently complex and variable that the established structure of the USP monograph standards process does not serve it well, and in fact, can impede technological progress or innovation,” noted Steven Kiozlowski, director of the Office of Biotechnology Products in FDA’s Office of Pharmaceutical Quality in an interview published by FDA (3).
Due to the inherent differences in biological products, the “sameness” standard used in USP monographs for chemical-based drugs cannot apply to biologic drugs, FDA argues.
USP, backed by patient groups and pharmacists, argues that the elimination of required standards would harm patients. In a letter to the committee, USP noted the role standards play in providing quality benchmarks; supply chain security; reliability and predictability for drug product development, manufacturing, and distribution; and promoting transparency and accountability that leads to patient trust (4).
“Essential to the framework that safeguards the quality and safety of medicines in the United States is the principle that public quality standards, required under the law, establish and articulate quality expectations for medicines, including biologics,” USP noted in the letter.
FDA has no legal authority to control the price of drugs. However, the agency notes it is “committed to facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines” and “makes sure that safe and effective drugs are available to improve the health of consumers” (5). That’s a lot of priorities to balance in a high-stakes, highly partisan environment.
1. S. 1895, US Senate, 116th Congress, 1st Session (Washington, DC).
2. J. Wechsler, “FDA Challenges USP Standards for Biologics,”www.PharmTech.com, June 25, 2019.
3. FDA, CDER Conversation: Ensuring That Standardization Does Not Impede Biological Product Innovation, www.fda.gov, June 12, 2019.
4. USP, Letter to Senate Committee on Health, Education, Labor and Pensions (HELP), June 11, 2019.
5. FDA, Frequently Asked Questions about CDER.
Vol. 32, No. 7
When referring to this article, please cite it as R. Peters, “A Biologics Partisan Divide," BioPharm International 32 (7) 2019.