Senator Orrin Hatch, the senior Republican in the United States Senate, and member and former chairman of the Senate Health, Education, Labor, and Pensions Committee, issued the following statement after voting in favor of the nomination of Dr. Robert Califf to serve as commissioner of the Food and Drug Administration.
“As an internationally recognized leader in his field, Dr. Califf has proven himself capable of leading an agency that serves the public good,” Hatch said. “His understanding of the ways research encourages drug and device development will be essential to achieving a high standard of care and reducing costs for consumers while maintaining incentives for manufacturers to innovate. I supported hisconfirmation today because I trust that he will continue to share with the Senate his plans to address bad actors in the dietary supplements industry and return to the process of issuing guidance to open-comment rule-making.”
On Dietary Supplements
On the issue of dietary supplements, Senator Hatch expressed hope that Dr. Califf, along with the new Office of Dietary Supplement Programs, will use their authority under DSHEA (the Dietary Supplement Health and Education Act) to remove bad faith actors and support efforts by the industry to ensure that products are safe and available to all. Hatch said, “In the past, questions on dietary supplement regulation have been met with hesitancy and uncertainty. I look forward to Dr. Califf using the authorities under DSHEA in a transparent way to coordinate with the DOJ to protect consumers from unsafe products without condemning the entire market.”
On Issuing Guidance
Senator Hatch believes the FDA has sufficient authority to issue rulemaking on the areas in its jurisdiction. Recently, the FDA has issued non-binding guidance instead of open-comment rulemaking. When the FDA holds companies accountable to decisions released in non-binding guidance, it creates unnecessary confusion in the market that has a tangible effect on innovation. Senator Hatch’s hope is that the FDA, under Dr. Califf’s leadership, uses its rulemaking authorities to engage stakeholders and determine the most appropriate practices in product development and approval.