Regulatory Focus™ > News Articles > Groups Protest Senate Bill’s Provision to Exempt Biologics From USP Standards

Groups Protest Senate Bill’s Provision to Exempt Biologics From USP Standards

Posted 24 May 2016 | By Zachary Brennan 

Groups Protest Senate Bill’s Provision to Exempt Biologics From USP Standards

Ten groups, including the US Pharmacopeial Convention (USP) and Biosimilars Council, are taking major issue with a provision in a seemingly innocuous bill to boost the workforces of the US Food and Drug Administration (FDA) and National Institutes of Health (NIH).

In a letter sent on Monday to Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), the American Pharmacists Association, ASHP, Academy of Managed Care Pharmacy, National Community Pharmacists Association and others are raising serious 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 made its way through the Senate HELP committee and 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,” according to the letter. “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. Such a review should be evidence-based and include an evaluation of the validity of assertions driving the proposed provision. Indeed, we have yet to identify any actual examples of the problem that the provision purports to address.”

In addition to frustrating the enactment of the Biologics Price Competition and Innovation Act of 2009, which created the pathway whereby biosimilars could be approved by FDA, this provision would also “undo an important component of the medicine quality safety net, create an unknown and potentially significant risk to patient safety, and undermine confidence in biological medicines, including biosimilars,” the groups said.

“Data shows that USP’s reference standards are extensively utilized by biosimilars manufacturers in the research and development process. They provide a benchmark for quality in drug development. Without them, biologics manufacturers would incur additional expense and delays by having to develop individual quality standards without a public benchmark. This would slow development, reduce predictability and increase costs,” they wrote.

Outside this provision, which is buried near the end of the bill text, the bill enables FDA to more fully participate in the Biomedical Research Service, a program currently used primarily by NIH. The bill also raises the number of people eligible for the service at both agencies from 500 to 2,000.

In addition, the bill would establish one or more “Intercenter Institutes” within FDA for a major disease area or areas, and help coordinate activities between FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.


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