
FDA Challenges USP Standards for Biologics
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
A provision in a Senate health reform bill has reignited debate over the whether biological products should have to meet product quality standards established by the US Pharmacopeial Convention (USP). FDA officials contend that efforts by the USP to publish product-specific monographs for biological products could hinder the development of innovative products, including competitive biosimilars. USP officials, with support from pharmacists and some patient and healthcare groups, maintain that monograph standards are important for ensuring the safety and quality of all drugs and biotech therapies.
The debate has intensified as the March 2020 date nears for a cadre of therapies, including insulin, to shift to falling under the rules applying to drugs to those governing biologics. This change is expected to facilitate the development of biosimilar versions of insulin products and other therapies in this group that have complied with USP monographs for years.
The new policy sought by FDA is contained in
The disputed language (section 207 of S. 1895) excludes all biological products regulated by the Public Health Service Act from meeting USP compendial standards, as is the case for conventional drugs. In a recent posting on the FDA website, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), note the
Similarly, Steven Kozlowski, director of CDER’s Office of Biotechnology Products, explains in another commentary that most widely used biological products do not have USP monographs, and that efforts to
Kozlowski maintains that adhering to USP standards would not necessarily prevent products from experiencing quality or safety problems and could make it difficult for a subsequent manufacturer to implement changes, such as a more efficient manufacturing process. While FDA supports USP monograph standards for conventional drugs, it prefers optional standards for biological products that align with the agency’s flexible approach for inherently complex biological products.
USP fights back
A coalition of pharmacists, public health, and patient organizations supports
The 21st Century Cures legislation of 2016 initially included a similar exemption for biologics from USP standards, but the final legislation dropped that provision. More recently, the administration’s budget proposal for 2020 includes a proposal to end the requirement that biologic products comply with USP quality standards. USP and its supporters maintain that public specifications for product purity and potency provide assurances for patient safety and foster competition in the market for biologics, particularly for insulin. FDA’s high-profile response reflects an escalation in the debate over whether the regulatory agency has to accept USP quality standards for all drugs and biologics, or if more flexibility would provide important benefits for the development of new therapies.
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