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# Califf Recommends FDA Reforms for Pandemic Bill
- URL: https://www.fdaweb.com/califf-recommends-fda-reforms-for-pandemic-bill/
- Published: 2023-05-04T12:00:00.000Z
- Updated: 2026-09-14T18:29:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154373

FDA commissioner **Robert Califf** says FDA needs improved operational readiness with its inspection oversight to be prepared for the next pandemic. Testifying 5/4 at a Senate hearing on reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), Califf shared agency lessons learned during Covid-19 and outlined critical authorities that should be in the bill for FDA to be ready when the next pandemic comes down the road.

“For example, FDA could achieve more effective and efficient oversight if it had authority to require internationally harmonized master files for drug manufacturing sites and improved authorities for conducting remote regulatory assessments,” Califf told the Health, Education, Labor & Pensions (HELP) Committee hearing. “Congress expanded FDA’s authority to request records in advance of, or in lieu of, an inspection to devices and bioresearch monitoring sites in the FY 2023 omnibus. However, the agency could better assure the safety of products, even in times of crisis, if this records requests authority were expressly extended to all FDA regulated products.”

Califf also recommended that Congress give FDA authority to establish a “specialized program” to defend against emerging pathogens and other threats. He said that FDA staff had to be pulled off other work to attend to pandemic issues for the past three years, leading to a significant backlog in certain areas and to fatigue. Through the creation of a specialized program, the agency would be “well positioned to respond to emerging and identified threats of concern” without sacrificing other important day-to-day public health work, he said.

Califf urged the HELP Committee to also consider adding needed diagnostic device reforms that were considered during the omnibus spending legislation. The agency had been hoping the omnibus could include the Verifying Accurate Leading-edge IVCT Development (VALID) Act that would have clarified its authority over lab-developed tests, but it and a dietary supplement listing mandate were omitted due to “opposition from stakeholders (including academic medical centers) as well as a reluctance by certain members to increase FDA’s authority,” according to a [summary](https://www.arnoldporter.com/en/perspectives/advisories/2022/12/us-fda-user-fee-riders-make-it-across-the-line?utm%5Fsource=mondaq&utm%5Fmedium=syndication&utm%5Fterm=Food-Drugs-Healthcare-Life-Sciences&utm%5Fcontent=articleoriginal&utm%5Fcampaign=article) by the law firm Arnold & Porter.

In Califf’s latest pitch, he told the hearing that Covid-19 “underscored the importance of both diagnostic test access and test accuracy, and the critical need for a modernized regulatory framework that applies to all in vitro diagnostics. This will be integral to ensuring the U.S. is better prepared for the next threat into realizing the full potential of diagnostic innovation.”

Additionally, Califf called for more modernized authorities for supply chain transparency. “There's a need for greater transparency into the supply chains of our medical products to both improve resiliency and ensure continued access for critical medical products,” he said. For example, under the CARES Act, FDA received new authority to require medical device manufacturers to submit shortage notifications during a public health emergency. FDA used this information to help mitigate approximately 350 shortages. “Unfortunately,” Califf said, “these notifications will no longer be required following the end of the current Covid-19 public health emergency (PHE). However, we know medical device shortages occur in many situations that are unrelated to PHEs including natural or human-made disasters, recalls geopolitical conflicts, production shutdowns and cybersecurity incidents. We also know that the shortages most often impact our most vulnerable and underserved populations like children, rural populations and our veterans and VA hospitals.”

Regarding drug shortages, Califf said the agency has recently seen an unprecedented demand for drugs and it would be helpful to require drug manufacturers and distributors to report surges in demand to help prevent or mitigate shortages, including for some critical over-the-counter drugs. Additional improvements could include reporting active pharmaceutical ingredient sources and the extent of manufacturer reliance on certain suppliers in the drug supply chain, he added.

To read Califf's prepared testimony, click [here](https://www.fda.gov/media/167839/download?ref=fdaweb.com).