The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by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.”
The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by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.”
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.