Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda

The US Department of Health and Human Services (HHS) has published its semiannual regulatory agenda that includes rules the Food and Drug Administration (FDA) plans to propose or finalize in the near future, as well as several longer-term efforts. The agenda lists more than 10 rules that would affect drugmakers, medical device manufacturers and patients.

In total, HHS listed 21 rules that fall under FDA’s purview, including eight planned proposed rules, eight final rules, four long-term actions and one completed action; this includes rules that cover other FDA-regulated products such as food and tobacco.

“The purpose of the agenda is to encourage more effective public participation in the regulatory process,” said HHS. “The regulatory actions forecasted in this agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration.”

HHS noted that the agenda also contains rulemaking to address the COVID-19 pandemic, expand access to health care, address health disparities and improve mental health.

Among the rules in the proposal stage is a rule that would amend FDA’s medication guide regulations to require a new form of patient labeling called Patient Medication Information. The labeling requirement would apply to drugs and certain blood products to make drug labels easier to understand by consumers.

“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,” HHS said.

FDA also plans to propose a rule that would outline regulatory expectations for conducting clinical pharmacology, clinical and analytical bioavailability (BA) and bioequivalence (BE) studies used in premarket submissions.

“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,” said HHS. “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.”

Another proposed rule in the works would establish good importing practices and registration requirements for commercial importers of drugs. While manufacturers are subject to regulatory requirements that ensure drug quality standards are met, the agency said that commercial drug importers are not held to similar standards.

“The unquantified benefits of the proposed rule include improvement in the safety of finished drugs allowed to enter the United States from the commercial drug importer’s requirement to register with FDA and for increased due diligence required by the importer regarding the safety of the drugs,” said HHS.

“There would also be cost savings to both FDA and industry from facilitating the review of documentation that ensures compliance with our regulations prior to being allowed to enter the United States,” the department added. “This proposed rulemaking will also enhance FDA’s ability to collect and analyze data to enable risk-informed decision-making while focusing on protecting the integrity of the global drug supply chain and ensuring safety, effectiveness, and quality of imported drugs.”

On the list of regulations FDA is in the process of finalizing is a rule that addresses direct-to-consumer prescription drug advertisements. The rule is meant to make it easier for consumers to understand the major statement – a required overview of a drug’s side effects and contraindications – in television and radio advertisements.

The final rule would require the major statement to be presented in a clear, conspicuous and neutral manner and would establish standards for determining whether the major statement complies with the regulation.

Other rules on the list include a proposed and final rule to name bulk substances that can or cannot be used to compound drugs in accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act, as well as a proposed rule on the distribution of compounded drugs under Section 503A.

The latter proposed rule would, if finalized, “Include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a state board of pharmacy or other appropriate state agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such state and distributed outside such state and in addressing the interstate distribution of inordinate amounts of compounded human drug products,” said HHS.

HHS semiannual regulatory agenda

Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda

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