USA – FDA, USP Clash Over Biologics Monographs

While the US Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) work closely with one another on many issues, the two are at odds over a proposal that would exclude biological products, including biosimilars, from requirements to adhere to USP monographs.

The proposal, which is included in President Donald Trump’s FY2020 budget request and a discussion draftcirculated by the Senate Health, Education, Labor and Pensions (HELP) committee last month, is being framed as a means of lowering drug costs and encouraging innovation.
In response to the discussion draft, USP and a group of ten other organizations sent a letter to HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) calling for the committee to drop the proposal, arguing that there is “no data or rationale” to back up claims that the proposal would lower drug costs or accelerate biologic and biosimilar development.
“In the last Congress, a similar proposal was rejected after robust engagement from numerous stakeholders during consideration of the 21st Century Cures Act. We are alarmed that the proposal is being reexamined and could find its way into legislation to be considered by the HELP or Appropriations Committees this year,” the groups write…