Groups protest Senate bill's provision to exempt biologics from USP standards

Ten groups, including APhA, are taking issue with a provision in a Senate bill to increase staffing at FDA and NIH. In a May 23 letter to Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), the groups raised red flags about Section 11 of the Biological Product Innovation in the FDA and NIH Workforce Authorities Modernization Act.

Ten groups, including APhA, are taking issue with a provision in a Senate bill to increase staffing at FDA and NIH. In a May 23 letter to Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), the groups raised red flags about Section 11 of the Biological Product Innovation in the FDA and NIH Workforce Authorities Modernization Act. This section of the bill, which is part of the package of Senate bills meant to complement the House-passed 21st Century Cures legislation, "is unrelated to the other sections of the legislation and appears not to have received meaningful discussion with the broader stakeholder community prior to its inclusion," the groups said. The section would exempt biologics from the requirement to adhere to USP public standards for quality. "If enacted, this provision would have potentially grave consequences for public health and would hinder, rather than support, our shared goal of getting safe and effective biosimilars to market," the letter states. "We respectfully request that the provision be omitted from any legislation that proceeds to floor debate during the remainder of this Congress. Any consideration of removing longstanding and publicly recognized standards and patient protections should include a robust and transparent discussion."