FDA, USP at loggerheads over need for biologics monographs

By PharmaCompass

2019-06-20

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The US Pharmacopeia (USP) and the FDA are at odds with each other over a proposal that would exclude biological products, including biosimilars, from requirements to adhere to USP monographs.

USP is an independent, non-governmental, not-for-profit organization that sets standards for medicines, food ingredients and other products sold in the US. The FDA works closely with USP to enforce USP’s standards, which are often called monographs. USP monographs for bulk drug substances and other ingredients provide standards for identity, quality, purity, strength, packaging and labeling.

According to the FDA, in the case of biological products, adhering to a monograph may actually hinder progress and does not offer additional quality assurances.

To date, very few biological products have monographs, Steven Kozlowski, director of the Office of Biotechnology Products in CDER’s Office of Pharmaceutical Quality, said.

The proposal, which is included in President Donald Trump’s FY2020 budget request and a discussion draft circulated by the Senate Health, Education, Labor and Pensions (HELP) committee last month, is being viewed as a means of lowering drug costs and encouraging innovation.

In response, USP and a group of 10 other organizations sent a letter to HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray asking the committee to drop the proposal, arguing that there is “no data or rationale” to support claims that the proposal would lower drug costs or accelerate biologic and biosimilar development.

According to USP, the current proposal “puts patient safety at risk, is opposed by prominent patient, healthcare practitioner and industry groups, and will inhibit competition in biologics.”

The FDA has resisted USP’s efforts on monographs for biological products for years. Back in March 2018, the FDA had said that USP’s efforts to develop biological product monographs could impede or delay licensure of biosimilars and other biologics.

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