USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device companies, with new proposals related to the Right to Try law, investigational new drug (IND) application reporting requirements and amendments to patent term restoration.

First Time Published in Unified Agenda

The proposed rulemaking related to the Right to Try Act of 2017, which cut FDA out of the process of granting certain compassionate use requests to investigational medicines, would require an annual summary from sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient.

“The Act requires FDA to specify by regulation the due date for the annual summary. This regulation will fulfill that requirement. Because the Act states regulation is required, FDA is not considering any alternatives to address the problem,” the plan for the rulemaking says, noting that it’s expected to be proposed in September.

FDA’s proposal is controversial because Sen. Ron Johnson (R-WI) said last May that the Right to Try Act is meant to “diminish the FDA’s power… It is not meant to grant the FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments.”

Just one patient has obtained access to an investigational drug under the 2-year-old law.

In addition to the Right to Try proposal, FDA is also seeking to release a proposed rule next March that would ease the burden of FDA’s requirements related to IND annual reports. The proposal would replace the current annual reporting requirement with a new requirement for a “development safety update report.” The plan is intended to better align with the International Council for Harmonisation and the report will be “more comprehensive, informative, and less burdensome than the IND annual report currently required by FDA.”…