FDA Program Seeks to Improve Quality, Innovation in Drug Development


A new FDA program aims to facilitate better quality drug manufacturing through recognized consensus standards.

The FDA is taking steps toward improving the quality of drug manufacturing while promoting innovation through a newly-released draft guidance, according to a press release.

According to FDA Commissioner Scott Gottlieb, MD, the agency’s draft guidance, called the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, proposes a program in which stakeholders and FDA officials will be able to propose pharmaceutical quality standard for potential recognition by the FDA. This set of agreed-upon “voluntary consensus standards” will take advantage of collaborative efforts between regulators, industry, and academia to pave the way for a more efficient drug development process.

“Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission,” Dr Gottlieb announced in a statement.

Through this program, the FDA hopes to streamline the assessment of information needed for the review of drug product applications and expedite pharmaceutical development. Dr Gottlieb noted that the agency’s recognition of a standard “may also reduce regulatory uncertainty, allowing applicants and manufacturers to utilize new or innovative approaches within their development programs.”

According to the FDA, greater transparency and clarity regarding the agency’s thinking on quality standard from pre- to postmarket can be beneficial in driving greater efficiency in drug development and manufacturing. The list of recognized consensus standards will be available publicly on the FDA’s website to help industry compile information for applications.

“Once we’ve recognized a standard, the applicants will generally not have to validate the approach outlined in the standard and can instead focus on appropriate use of the method and the acceptance criteria,” Dr Gottlieb explained.

The proposed program does not apply to standards that are already legally binding, such as provisions of the Federal Food, Drug, and Cosmetic Act, but will facilitate recognition of other quality standards.

One area where Dr Gottlieb suggests the program will elicit a positive effect is in generic and biosimilar drug manufacturing, where he noted that streamlining the development of these products is important in increasing competition in the marketplace.

Last year, the FDA published a draft guidance for the industry that provided a risk-based approach to regulatory oversight of post-approval manufacturing changes, including a framework for applicants to gain agreement with the agency on the established conditions (ECs) necessary to ensure product quality. A new pilot program will focus on receiving, assessing, and engaging with applicants regarding proposed ECs.

“We’ll continue to expand our efforts with established conditions and drug competition to help facilitate the development and marketing of safe and effective drugs for consumers,” Dr Gottlieb concluded.


Statement from FDA Commissioner Scott Gottlieb, MD, on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs [FDA statement]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631293.htm. Accessed February 13, 2019.

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