FDA Proposes Path for Voluntary Pharmaceutical Quality Standards

The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by achieving “voluntary consensus standards.”

In a statement, FDA Commissioner Scott Gottlieb, MD, said the changes are aimed at improving quality, lowering drug costs, and reducing regulatory uncertainty. The Center for Drug Evaluation and Research (CDER) unveiled a 7-page document called the Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. The program would be different from formal recognition of quality as established by the Center for Devices and Radiological Health.

Instead, it would facilitate submissions by external stakeholders and CDER staff with the aim of fostering innovation and streamlining the compilation and assessment of marketing applications for products regulated by CDER. Use of an informally recognized consensus standard will be strictly voluntary, and even if a developer uses one of the voluntary standards, CDER may still request that the applicant provide additional information to support an investigational new drug (IND) application or a marketing application.

“While this program is intended for all drugs, brand and generics, we know that it will have a positive effect in supporting more efficient development and production of generic drugs, which often operate under small margins compared to brand drugs,” said Gottlieb. “Creating efficiencies in generic and biosimilar manufacturing is an important part of our work to streamline generic and biosimilar development overall, to help spur competition in the prescription drug market as part of our Drug Competition Action Plan (DCAP) and Biosimilar Action Plan.”

Voluntary recognition of a standard may also reduce regulatory uncertainty, he said. If a standard has been recognized, applicants can focus on appropriate use of the method and the acceptance criteria instead of validating the approach outlined in the standard.

The informally recognized standards related to pharmaceutical quality will be publicly available. Gottlieb said the program does not apply to standards that are already legally binding.

In another move, the FDA will also announce a pilot program aimed at increasing the efficiency of “established conditions” used in the product's lifecycle post-approval.

The pilot will build on draft guidance released last year called “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The guidance is a risk-based approach to regulatory oversight of post-approval manufacturing changes. It gives a mechanism for applicants to gain FDA agreement on the established conditions (ECs) necessary to ensure product quality, and to facilitate postapproval changes to those established conditions.

The pilot will assist with receiving, assessing, and engaging with applicants regarding proposed ECs, which are intended to help reduce submissions of unnecessary postapproval supplement applications. Manufacturers will be encouraged “to continually improve their processes using the agreed-upon ECs as their guardrails,” Gottlieb said. “This can help promote manufacturing innovations that can improve the quality and safety of drug manufacturing, and potentially lower the cost of finished drug products.”