The Senate on Tuesday narrowly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration, a key federal agency that has been without a permanent chief for more than a yearlong stretch of the coronavirus pandemic.
The vote was 50-46, with six Republicans crossing the aisle to support him while five Democrats opposed him. One senator voted present.
“Califf 2.0 will unleash the power of the FDA to drive innovation, enhance health literacy and health equity, broaden access to new drugs, and put a stop to drug company shenanigans, said Peter Pitts, former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest. “Now is the time for the FDA to shine.”
Six weeks later, Senator Ron Wyden (D-Ore.), who chairs the U.S. Senate’s Committee on Finance, sent Califf a letter asking him to clarify his position on accelerated approval. He asked Califf five important questions:
A more potent and progressive way to address the issue would be for Congress to pass the Promising Pathways Act. Its premise and specific recommendations respond directly to Wyden’s questions and the broader regulatory science and public health issues they raise. Its sponsor, Senator Mike Braun (R-Ind.), sits on the Senate’s Committee on Health, Education, Labor, and Pensions. That means he will be part of the Senate’s hearings to reauthorize the Prescription Drug User Fee Act, and could propose that the pathways act becomes part of this “must pass” legislation. Read more
The US Senate website describes the main points of the Promising Pathways Act as follows:
- This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable.
- The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.
- During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis.
- The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties.
- A provisionally approved drug must be labeled as such.
- If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.
- The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective.
- Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
Banner Image: Dr Califf. Image Credit – Dr Califf