The US Department of Health and Human Services (HHS) has published its semi-annual regulatory agenda. The agenda presents the regulatory activities the Department expects to undertake in the near future and lists 21 rules in total. The agenda includes approximately ten rules that involve drugmakers, medical device manufacturers, and patients. Of particular note, the list includes a proposed rule that would amend FDA’s medication guide regulations to require patient labeling called “Patient Medication Information” in a new, easier-to-comprehend format and a final rule concerning direct-to-consumer prescription drug advertisements in television and radio format. The final rule would require the major statement, of drug side effects and contraindications to be presented in a clear, conspicuous, and neutral manner, thereby making it easier for consumers to understand.
A copy of the Federal Register is available here.
For more information about FDA guidance, please take a look at the OPDP Promotional Violations section of the Enforcement Actions Database.