HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules

Regulatory NewsRegulatory News | 21 February 2023 |  By 

The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year. It includes several rules that the Food and Drug Administration (FDA) will work on to address issues such as patient labeling, conduct of clinical trials and drug compounding.
On 22 February, HHS published its semiannual regulatory agenda, which included a number of rules either under development or set to be finalized by FDA, as well as a timetable for expected completion. Notably, several of the rules, including a rule on medication guides, have been listed in the regulatory agenda for multiple years.
Rule Title Regulation Identifier Number
Proposed Rule Stage
Medication Guide; Patient Medication Information 0910-AH68
Requirements for Tobacco Product Manufacturing Practice 0910-AH91
Administrative Detention of Tobacco Products 0910-AI05
Nutrient Content Claims, Definition of Term: Healthy 0910-AI13
Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies 0910-AI57
Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review) 0910-AI70
Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review) 0910-AI71
Final Rule Stage
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format 0910-AG27
Sunlamp Products; Amendment to the Performance Standard 0910-AG30
Mammography Quality Standards Act (Reg Plan Seq No. 63) 0910-AH04
General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products 0910-AH14
Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act 0910-AH81
Revocation of Uses of Partially Hydrogenated Oils in Foods 0910-AI15
Tobacco Product Standard for Characterizing Flavors in Cigars (Reg Plan Seq No. 65)
Tobacco Product Standard for Menthol in Cigarettes (Reg Plan Seq No. 67)
Long Term Actions
National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers 0910-AH11
Nicotine Toxicity Warnings 0910-AH24
Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) 0910-AH56
Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products 0910-AI61
Among the proposed rules, FDA is planning to amend its medication guide regulations to require a new form of patient labeling called Patient Medication Information from sponsors when they submit drug and blood product applications to the agency for review.
“The proposed rule would include requirements for Patient Medication Information development and
distribution,” the agency said. “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.”
FDA also proposed updating its regulations to clarify its expectations for how sponsors should conduct studies for clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies when they are developing a drug or biologic. This rule has also appeared in previous iterations of HHS’s semiannual regulatory agenda.
“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,” the agency 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.”
On its list of rules that FDA is finalizing is one that addresses direct-to-consumer (DTC) advertising of prescription drugs relating to the presentation of the major statement in television and radio ads.
“Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement,” said FDA. “The rule would 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 rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.”
Other issues that made the list of regulatory priorities, include multiple tobacco standards and three rules related to drug compounding.


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