FDA reveals plans for several new regulations in latest Unified Agenda

The White House’s Office of Management and Budget (OMB) has released its updated regulatory agenda, outlining regulations that the federal Departments intend to release in the upcoming year. After a relatively stable agenda for the last few years, the FDA has several new additions to its Rules List.

A quick background on OMB’s Regulatory Agenda

• Twice a year, the White House’s Office of Management and Budget (OMB) releases a regulatory agenda for each government agency, including independent agencies. The agenda lists the upcoming proposed and final regulations that each Department and agency plans to release, providing public insight into each agency’s regulatory priorities for the year ahead. In addition, each Department or agency releases a semi-annual regulatory agenda detailing the significant regulations it plans to propose, finalize or withdraw in a given year.
• While no agency is obligated to release the regulations on its list during a calendar year, the list is often helpful to determine which regulations have been either been newly added or removed, which may indicate shifting regulatory agendas at an agency.

The new unified agenda (“Fall 2021”) was released December 10, 2021.

• The FDA’s portion of the agenda carries over most of the policies from the previous iteration. In total, the recent agenda listed 59 items in the proposed rule stage for the FDA, with an additional 24 policies in the final rule stage. This includes 19 new proposed rules and six new final rules. Additionally, there were five final rule deletions, and one proposed rule deletion.
• Among the many items carried over from the Spring 2021 version of the agenda, the FDA still plans to propose rules on increasing access to over-the-counter drug products, harmonizing International Review Board (IRB) provisions, harmonizing and modernizing the medical device Quality System regulation and updating regulations on post-approval changes to approved NDAs, ANDAs and BLAs. While the proposed rules on post-approval changes and IRB regulations are expected in 2022, both the Quality System rule and the OTC rule are still listed as having a December 2021 timetable for publication. While the target publication dates are not binding, this could indicate that progress on these regulations is in more advanced stages and the release of the rules is imminent.
• There are also many new policies listed under the updated agenda. As AgencyIQ has previously discussed, the Spring 2021 regulatory agenda for the FDA was somewhat stagnant, including only one additional rule added for drugs or devices. Instead, that agenda focused more on removing rules, in some cases as a clear walk-back of Trump Administration policies like the Good Guidance Practices proposed rule. While there were more additions to the list under the new (Fall 2021) agenda compared to the Spring 2021 list, which was the only other agenda published during the Biden Administration, many of the policies have still appeared in older agendas, according to OMB.
• Only two of the rules on the Fall 2021 agenda are completely new. According to the list, the Revocation of Methods of Analysis Regulation will seek to eliminate an unnecessary policy which calls for the FDA to use a method of analysis “not prescribed in a regulation.” The proposed rule is listed for publication in March 2022. In addition, a new rule that would update the FDA’s Bulks List is also new to the unified agenda. While the agency previously included a similar final rule in its Spring 2021 agenda, the new listing implies that the FDA may intend to issue a new proposed rule to address Active Pharmaceutical Ingredients (APIs) that can be used to compound drug products.
• Other rules that have been added to the agenda since the Spring 2021 version, but have previously appeared, include regulations on current good manufacturing practices (cGMPs), blood donor eligibility, biologic products regulation and compounding, among other topics. The cGMP rule will be specific to outsourcing facilities. The proposed rule is expected to be published in July of 2022 and will set minimum cGMP requirements for human drugs compounded by outsourcing facilities.
• Blood donor eligibility policies could be issued by May. The updated agenda includes a proposed rule on donor eligibility requirements and donation suitability for blood and blood components. Specifically, OMB writes that the “proposed rule would revise and permit limited exceptions to certain donor eligibility and donation suitability requirements,” and “provide more flexibility to accommodate advancing technology.” These potential policy changes come after the FDA has initiated research on donor eligibility processes and published guidance on new technology for “cleaning up” blood donations.
• Updates related to biologics are also included. The FDA’s new agenda includes a proposed rule entitled “Biologics Regulation Modernization,” which looks to clarify the BLA process and align regulations with the Biologics Price Competition and Innovation Act. OMB notes that regulations must be updated to reflect the “existence of biosimilar and interchangeable biological products.” The goal of the rule is to provide clarity to manufacturers of those products and eliminate potential policy loopholes that could hamper biologic product market competition. The proposed rule is listed with a publication date of August 2022.
• For devices, the FDA is looking to address clinical holds. While details on the policy are limited, the listing states that the rule would “create procedures for suspending…a clinical investigation of a medical device” – in other words, in placing a “clinical hold” on a device investigation. The regulation would codify processes by which the agency can order a device study to halt, as outlined in section 520(g)(8) of the Federal Food, Drug and Cosmetics (FD&C) Act, which was added to the statute under the FDA Safety and Innovation Act (FDASIA) (section 606) in 2012. The proposed rule is listed for publication in May 2022.
• Many of the final rules added to the agenda look to harmonize regulations and provide additional clarity. The fixed-combination and co-packaged drug final rule will seek to “harmoniz[e] the combination drug requirements into a single set of regulations for both prescription and OTC combination drugs and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met,” listed with an expected publication date of May 2022 (following the 2015 proposed version of the rule). Similarly, the direct-to-consumer advertising final rule will “revise the regulation to reflect the statutory requirement that in DTC advertisements for human drugs in television or radio format, the major statement relating to side effects and contraindications of an advertised prescription drug must be presented in a clear, conspicuous, and neutral manner.” This regulation is preliminarily slated for September 2022 publication, following the 2010 publication of the proposed version of the rule.
• The agenda does reflect some recent progress in rulemaking. The agency issued final rules on De Novo classifications and “intended use” in the second half of 2021 – and have therefore been removed from the agenda. [Read AgencyIQ’s full analysis on both the “ intended use” rule and De Novo rule]
• Overall, the agenda indicates that the FDA is going back to regular business. As previously mentioned, the last iteration (Spring 2021) of the federal unified agenda included very few changes compared to the previous version (Fall 2020). With the COVID-19 pandemic requiring the full attention of regulators, publishing non-emergency-response regulations largely fell to the wayside, especially with a new administration looking to set its own practices and review actions by the previous administration.
• Going forward, while the Unified Agenda’s listed publication dates are not binding, the addition of new policies to the list likely means that federal officials are, at a minimum, considering their non-COVID related workload heading in to 2022. For life sciences companies, this could mean a return to regular engagements with the agency and increased predictability, as long as the public health context of the pandemic holds stable.

List of new agenda additions related to drugs and devices since Spring 2021

To contact the author of this article, please email Lily Rosenfield.
To contact the editor of this article, please email Alec Gaffney.

Key Documents and Dates

• Regulatory Agenda: Semiannual Regulatory Agenda