FDA Falls Short of User Fee Goals but Still Seeks Double the Budget

WASHINGTON — Members of the Senate Committee on Health, Education, Labor and Pensions wanted to know why the U.S. Food and Drug Administration is requesting nearly double its annual budget while failing to meet many of the goals tied to user fee agreements. 

“It should be unthinkable that after two years when FDA’s work has been more important than ever, that we would fail to get this done or force the agency to send pink slips,” said Sen. Patty Murray, D-​​Wash., who serves as chairwoman of the Senate HELP committee, during a hearing held Tuesday.

“But it should also be unthinkable that we would let this moment slip by without looking carefully at what is and is not working at FDA,” continued Murray.

The FDA user fee legislation, which will be evaluated by the committee in just a few weeks, ensures that as the FDA gets more new drugs or devices to consider for approval — it also gets more resources to support that work.

“There’s an elephant in the room. The FDA has a responsibility to meet the terms of the commitments made under the user fee programs. Based on my evaluation [the FDA] has not fully delivered,” said Sen. Richard Burr, R-N.C., ranking member of the Senate HELP Committee, during the hearing. 

According to Burr, for the drugs program for FY 2019 and 2020, the FDA missed 12 out of the 14 user fee goals relating to product development and meetings with sponsors.

“Meeting two of 14 goals is a 15% success rate,” said Burr. 

Burr said that for the biosimilars program for FY 2020, the FDA only reviewed 50% of the applications on time, and missed seven out of 15 goals related to biosimilar product developments. 

For the medical device program, Burr said the FDA is three months late in finalizing agreements after they refused to acknowledge they did not meet their goals from the last user fee agreements. 

“Now, FDA wants double the money for mediocre performance improvements … and longer review times,” said Burr. 

One area where the FDA has requested more money is in new hires to boost cybersecurity for medical devices.

Jeffrey Shuren, director at the Center for Devices and Radiological Health, said during the hearing the FDA received only $500,000 to support the work in medical devices and cybersecurity.

That’s why Shuren said the FDA requested an additional $5 million in the budget proposal for FY 2023 and requested more authority to ensure that medical devices are cybersafe. 

Sen. Jacky Rosen, D-Nev., advised during that hearing that she will soon introduce legislation to shore up cybersecurity for medical devices.

“Cyberattacks are a growing threat to our health care sector … I’m working on additional legislation to ensure cybersecurity guidance for medical device manufacturers. We want that guidance to be up-to-date and nimble … so that they are easy to understand and easy to access for health care providers,” said  Rosen. 

On April 8, the FDA released updated cybersecurity guidance for medical device manufacturers which replaces a former report on the subject from 2018.

The draft of the guidance comes as the U.S. Cybersecurity and Infrastructure Security Agency has been issuing warnings that the invasion happening in Ukraine may increase the risk of cyberattacks in the U.S. health system. 

The updated guidance from the FDA is currently open for public comment period until July 7. 

Members from the Senate HELP committee also questioned the FDA over a legal determination made in the U.S. Court of Appeals for the 11th Circuit in September 2021, which found that the FDA unlawfully infringed on an exclusivity period it awarded to Florida-based Catalyst Pharmaceuticals Inc. to treat a rare autoimmune disease when it approved a lower-cost version.

“The situation right now … is that a sponsor could study a disease in a very narrow segment of population, and then be able to block further approvals throughout the entire condition that drug could address. It’s very concerning,” said Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research at the FDA, during the hearing. 

“We want to work with Congress to find solutions,” continued Cavazzoni.

Many of these failures, according to three FDA center directors during the hearing, relate to inadequate staffing levels and low levels of FDA authority to make recalls.

Cavazzoni said that the FDA in many cases does not have mandatory recall authority for drugs, including for over-the-counter products, with the exception of biologics.

She said this impacted the FDA’s ability to timely respond to a recall of 176 hand sanitizers which were imported from another country and found to be contaminated with methanol, which lead to several deaths and blindness in individuals. 

“We could have intervened much faster and much more effectively had FDA had the mandatory recall authority for drugs, including over-the-counter drugs,” said Cavazzoni. 

During the hearing, Murray reminded the FDA that this pattern of delay and dysfunction has also been seen in the failure to respond to the presence of arsenic and other metals in baby food, or contaminated infant formula. 

“The FDA first received complaints about [contaminated infant formula] last September, but it was only recalled earlier this year,” said Murray.

Murray also pressed the FDA as to when vaccines for children under 5 will be available, and why there has been a delay.

“Once we have a fully complete emergency use application, we’ll move quickly … it’s one of our highest priorities,” said Peter Marks, director of the Center for Biologics Evaluation and Research, during the hearing.

According to Marks, in the next week the FDA will make public a tentative timeline for when the public advisory committee will meet to discuss several expected applications, but that the FDA cannot finish reviews until they have the completed applications.

“Unfortunately, we can’t comment publicly … the manufacturers will generally make an announcement when they make a full and complete application for emergency use,” said Marks. 

 Alexa Hornbeck can be reached at [email protected]