Statement on Inclusion of Section 11, Biological Product Innovation in the FDA & NIH Workforce Authorities Modernization Act

In March of 2016, a provision was added to the FDA and NIH Workforce Authorities Modernization Act (S. 2700), that would exempt biological medicines from the requirement to adhere to U.S. Pharmacopeial (USP) standards for quality. The provision appears to be unrelated to the content of the larger bill, and it seems to have been added at the last minute and without sufficient stakeholder input during Health, Education, Labor and Pensions (HELP) committee markup.

Pfenex is aligned with the Generic Pharmaceutical Association, USP, the American Pharmacists Association, and other stakeholders that, if passed, this provision could remove important global drug quality and safety standards that have been in place since 1906. These longstanding and publicly-recognized standards are used in more than 140 countries around the world, helping to ensure patient, provider, and pharmacist confidence in the safety, and quality, of medications. For drug developers, USP standards provide a set of global, nonproprietary benchmarks for drug purity, potency, identity, and quality to which manufacturing specifications must adhere.

The standards encourage competition in the marketplace which can facilitate increased patient access to life-changing therapies. We urge legislators and the U.S. Food and Drug Administration (FDA) to reject this provision so that providers and patients can continue to have access to biological medicines of the highest quality.