WASHINGTON — 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.”

At his confirmation hearing in December, Califf said he is “a fan of accelerated approval for the right conditions.”

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.

Healthcare Distribution Alliance (HDA)president and CEO Chester “Chip” Davis said about the appointment:  “HDA congratulates Dr. Califf on his confirmation to serve as the FDA Commissioner. Under Dr. Califf’s leadership, HDA and its members look forward to continuing our work alongside the agency to help ensure that lifesaving medicines are available to patients when and where they need them, especially as our nation’s response to COVID-19 evolves and as we work to fully implement the Drug Supply Chain Security Act, a groundbreaking law that will further enhance the safety and efficiency of our nation’s healthcare supply chain.”

“The Association for Accessible Medicines (AAM) congratulates Dr. Robert Califf on being confirmed to lead the U.S. Food and Drug Administration (FDA). AAM and its member companies stand ready to work with Dr. Califf to ensure America’s patients have timely access to safe, effective and quality generic and biosimilar medicines,” said the AAM in a statement.

The Council for Responsible Nutrition (CRN) also applauded today’s confirmation of Dr. Califf as commissioner.

The following is a statement from CRN’s president and CEO, Steve Mister:

“Congratulations to Dr. Califf on his confirmation as FDA Commissioner. CRN supports his confirmation, and we look forward to working with Dr. Califf and other FDA leaders to keep strengthening the dietary supplement and functional food industry and protecting consumers’ ability to access safe and beneficial products. We’ll do this together by ensuring products continue to meet all regulatory requirements.

“Dr. Califf’s confirmation comes at a pivotal time for this industry. Consumers are more proactive than ever about their health—four out of five Americans use a dietary supplement, according to CRN’s latest consumer survey. This industry needs a robust and responsive FDA that enforces the law, addresses safety concerns, and provides incentives for continued innovation and high-quality manufacturing. As Dr. Califf begins planning his agenda, we urge him to prioritize the following action items:

1. Increase funding to the Office of Dietary Supplement Programs (ODSP) at FDA, recognizing this Office must keep pace with the rapidly growing industry it oversees
2. Work with Congress to enact legislation to establish mandatory product listing for supplements
3. Establish a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement
4. Issue final guidance on the labeling of probiotics
5. Issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law
6. Protect consumers and strengthen incentives for innovation with more proactive enforcement of the existing law for dietary supplements

“CRN has enjoyed a strong working relationship with FDA for nearly 50 years, and we look forward to continuing under Dr. Califf’s leadership. Together, we can work toward the shared goal of growing an innovative and safe dietary supplement marketplace that protects consumers, while keeping at bay unnecessary regulatory burdens for the industry.”