What Dr. Califf Said to the Senate; What CVM Director Dr. Solomon Said to the Alliance

What Dr. Califf Said to the Senate; What CVM Director Dr. Solomon Said to the Alliance.

Dr. Califf’s Testimony to the Senate – April 28, 2022
FDA Commissioner Robert Califf appeared on Thursday, April 28, 2022, before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies in support of FDA’s Fiscal Year (FY) 2023 budget request.

The hearing was generally supportive of FDA’s mission with Chairwoman Tammy Baldwin (D-WI) saying she wants to continue the upward trajectory of FDA’s efforts and be sure that FDA has the resources it needs for its mission. Ranking Member John Hoeven (R-ND) noted that FDA regulates $2.5 trillion of products, and the rest of the world looks to FDA for its standards. He also expressed concern that there have been seven FDA Commissioners over the past decade, while long-term planning and stability are important.

In his opening statement and throughout his responses to questions from several Senators, Dr. Califf consistently highlighted the same three issues that the Alliance repeatedly raised in its meetings with Hill offices: data modernization and technology; personnel needs; and buildings and facilities with a significant backlog of maintenance and repairs.

About technology modernization, he repeated the phrase “In God we trust – all others must bring data,” saying FDA is not at the technological level it needs to be to facilitate innovation and to protect the public. He said inspectors enter data into outmoded systems and that each FDA Center has its own technology, making sharing information difficult.

Ranking Member Hoeven’s expressed concern about the seven Commissioners over the past decade. Commissioner Califf responded by observing that every living Commissioner has written about the challenges faced by each Commissioner with the job being a particularly tough one.

A more complete Alliance summary is here. The Commissioner’s prepared statement can be found here. A video of the hearing can be found here.

Dr. Solomon’s Webinar with the Alliance for a Stronger FDA---April 22, 2022
The Alliance for a Stronger FDA on April 22 continued its FY 23 FDA budget priorities webinar series with Dr. Steven Solomon, DVM, Director of FDA’s Center for Veterinary Medicine.

Dr. Solomon provided an overview of CVM’s work. It is the smallest of the various FDA Centers, representing just 4% of FDA’s budget. They have 700 FTEs, overseeing a $560 billion industry. Two-thirds of all households have pets. Food producing animals are particularly important both for nutrition and for human health.

Goals for CVM over the next five years - Very active on antimicrobial resistance, seeing challenges increasing exponentially. The development of more innovative products will require more people, technology enhancements, and strategies for dealing with emergency issues. More oversight of animal food will be needed, looking at pet food safety and enhancing mutual reliance with states. Post-market surveillance on the drug side is needed. While there are 100,000 adverse event reports each year only 25% are looked at. The animal food industry is increasingly innovative, and FDA needs to be prepared.

CVM’s hiring priorities – CVM has a fairly low attrition rate. While lots of people would like to work at CVM, they do not have the resources to hire them. They are doing horizon scanning to determine what skills they will need in the future. He mentioned geneticists, bio-informaticists, and statisticians.

Most exciting areas of innovation – He suggested veterinary regenerative medicine; animal cell and tissue production; the need for good high-quality data from scientific studies; animal genetic information; investment in research infrastructure; veterinary innovation program; and new guidance on the use of biomarkers.

A more complete Alliance summary is here. The online video of the webinar can be found here.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.