HHS regulatory agenda for 2021 is light on new proposed and final FDA rules
The impact of the coronavirus on the FDA’s work plans is evident in the latest semi-annual regulatory agenda for HHS, which includes only two new biopharma-related proposed rules and one final rule.
The two proposed rules center on one that seeks to change FDA medication guide regulations and another to clarify FDA’s study conduct expectations for analytical and clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies.
In the case of updating FDA medication guide regulations, the agency is seeking to require drug sponsors of outpatient drugs to submit a new form of patient labeling to be reviewed by the FDA.
“The proposed rule would include requirements for Patient Medication Information development and distribution,” HHS says. “The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.”
For the other proposed rule that HHS expects to undertake in the foreseeable future, FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA’s study conduct expectations for analytical and clinical pharmacology, BA and BE studies that support human research and marketing applications.
“The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies,” HHS said. “This regulation would align with FDA’s other good practice regulations, would also be consistent with current industry best practices, and would harmonize the regulations more closely with related international regulatory expectations.”
Other previously proposed FDA rulemakings, such as revisions around when the FDA can refuse a generic drug application or the modernization of FDA’s biologics regulations, were not included in the latest HHS agenda.
The one final FDA rule on the HHS’ agenda this year deals with a proposed rule from 2019 that will amend the agency’s 503A Bulks List, which is a list of bulk drug substances that can be used in compounding.
The final rule will add five additional bulk drug substances to the list, including Glutaraldehyde, Glycolic acid, L-citrulline, Pyruvic acid and Trichloroacetic acid. The rule will also identify 26 bulk drug substances that FDA has decided not to include on the 503A Bulks List. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking, HHS said.