July is expected to be a slow month for regulatory actions, with only a small number of FDA-hosted and industry-hosted meetings scheduled. There are also not many legislative or user fee-driven deadlines for the FDA to meet. However, when the FDA released its updated Unified Agenda in June, it listed several regulations that it expected to publish in July. This suggests that these regulations are in the final stages of completion and are undergoing administrative checks. Six regulations are expected to be sent to the White House for review, with another one likely to be published this month.
One of the regulations expected to be published in July is related to direct-to-consumer prescription drug advertisements. The FDA is amending its regulations to require that major side effects and contraindications of prescription drugs be presented in a clear, conspicuous, and neutral manner in TV and radio advertisements.
Another regulation is focused on recalls of products subject to FDA jurisdiction. The FDA is seeking comments and information to inform its intention to revise the Agency’s guidance on policy, procedures, and industry responsibilities for recalls.
The FDA is also proposing a rule that would establish requirements for requesting records in advance of or in lieu of an inspection, as well as participation in a remote interactive evaluation, of establishments that manufacture certain human cells, tissues, and cellular and tissue-based products.
The performance standard for sunlamp products and ultraviolet lamps intended for use in these products is also being updated to improve safety, incorporate new scientific information, and align with international standards.
The FDA is implementing its authority to administratively destroy refused drugs valued at $2500 or less, and is now extending that authority to include refused devices such as test kits, respirators, and face masks related to COVID-19, as well as illegal contact lenses.
A method of analysis regulation will be revoked, as it is no longer necessary. Additionally, there will be a minor amendment to establishment registration and device listing requirements for manufacturers of human cells, tissues, and cellular and tissue-based products regulated as devices. This amendment aims to correct an inconsistency in FDA regulations.
These regulations are currently under review by the White House’s Office of Information and Regulatory Affairs (OIRA), which ensures that federal policies and regulations adhere to laws, existing regulations, federal policies, and the President’s wishes. Once cleared by OIRA, the regulations can be released by the FDA.
In conclusion, July is expected to be a slow month for regulatory actions, but there are several regulations that the FDA expects to publish. These regulations cover a range of areas, including direct-to-consumer drug advertisements, recalls, requirements for requesting records, performance standards for sunlamp products, administrative destruction of refused devices, revoking a method of analysis regulation, and amending establishment registration and device listing requirements. These regulations are currently under review and will be published once cleared by the White House’s OIRA.
