Industry: Provision in Workforce Bill Would Risk Biologics Quality

Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality.

In a letter to Senate HELP Committee Chairman Sen. Lamar Alexander (R-Tenn.) and ranking member Sen. Patty Murray (D-Wash.) — who are sponsoring the bill — 10 different organizations write that a portion of the bill would “hinder” the ability of drugmakers to bring safe and effective biosimilars to market.

The section in question adds to an existing provision on application approval which states that the “official compendium” of USP “shall not apply to a biological product” regulated under that section.

The groups — which include the Biosimilars Council, the American Pharmacists Association, and USP — say the provision could hurt development of biologics and biosimilars, noting that manufacturers extensively use the USP reference standards.

“Without them, biologics manufacturers would incur additional expense and delays by having to develop individual quality standards without a public benchmark,” the letter says. “This would slow development, reduce predictability and increase costs.”

The FDA and NIH Workforce Authorities Modernization Act was one of the 19 bills the HELP Committee advanced to the full Senate floor as part of the upper chamber’s version of the 21st Century Cures Act (DID, April 7). There is no similar provision regarding the USP standards in the House bill.

The Senate and the House must agree on an identical biomedical innovation package before sending it to President Obama. — Michael Cipriano

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