Industry standard

FDA computer systems ’20 years behind’ industry standards, official says

WASHINGTON — The FDA is “20 years behind the industry standard” in its information technology (IT) operations, said Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER ) from the agency, during a briefing sponsored by the Alliance for a Stronger FDA.

“We really want to modernize our business processes, which will require new IT systems… [and] move to the next level of security monitoring systems,” Marks said at Tuesday’s event. “And it will really take a huge investment in IT partnerships and contracts to get there.

Marks, who became director of CBER in 2016, outlined his top eight priorities for the agency:

Response to the COVID-19 outbreak. “We still have a very important role in the licensing and approvals of COVID-19 vaccines,” Marks said. “This includes managing additional vaccine submissions for emergency use authorizations for expanding populations – in, for example, younger pediatrics [groups] — and to manage booster vaccinations and then transition those emergency use authorizations to traditional approvals, which will likely have to happen sometime in the next year as well. »

Elimination of the backlog of applications. “We did a pretty good job of not missing the important PDUFA dates [deadlines for making decisions on biologics applications], but in some cases, we are late getting feedback from users on their apps,” Marks said. So we want to try and do our best to clear up this backlog of applications by the end of the year.”

Accelerate work on gene therapies. “There’s been a lot of discussion about whether the center takes a more cautious or a more liberal stance toward gene therapy,” he said. “We see this as an incredibly exciting area, which will obviously require a great deal of care, as any fledgling area does when it develops, so we will continue to work diligently with sponsors and stakeholders to try and get things done. .”

CBER will also “likely begin to explore what might be potential intermediate pathways for certain cell therapy products,” he added. “We are aware that there are some cell therapy products that clearly fall outside our tissue rules because they do not require pre-marketing authorization, and yet they are probably not ideally regulated by the submission of full license applications for biologics, so we’re going to explore whether there’s an intermediate route that might be appropriate there, and that’s an exploration that I think is important, as we’re trying to look at those things that we regulate to find the best methods to put them forward for the benefit of patients.”

Produce more timely ratings and reviews. Marks called it a “major priority” for his agency.

Advance blood donation policies. “This year is crucial to complete a blood donation study looking at our blood donor deferral criteria and how we could potentially go beyond our current set of deferral criteria – for example, for HIV, which would be perceived as gender-neutral exclusion. criteria,” Marks said.

Taking regulatory science to the next level. “This includes additional work in the targeted applied science of manufacturing and product characterization,” he continued. “Sometimes people don’t realize it, but we have about 80 principal investigators who work at CBER… They’re investigator reviewers and they make a big difference because they tend to keep up with the cutting edge of science, which which helps that they better look into the products offered to them.”

Improve CBER’s business processes. “Clearly, we need to modernize our business processes and information technology systems to better serve public health,” Marks said.

Increase workforce diversity. “We need to recruit, retain and train a diverse professional workforce that can keep pace with the wealth of new products coming our way,” he said. Hiring for the agency will be a little easier now that remote work is becoming more acceptable, Marks said. “We have now realized that we can have at least a reasonable fraction of our workforce … in remote locations, so hopefully this will allow us to tap into a larger pool of talent to obtain a workforce. diverse work with the experience we hope to have.”

Marks also addressed the question of what he would do if he had more money to spend than is currently in President Biden’s budget for the next fiscal year. “First of all, we would hire more vaccine and gene therapy reviewers because I think we’re clearly in a position where we’re not giving the kind of feedback I’m comfortable with in real time.” , did he declare. “We are hiring now, but we would go even further.”

Marks said he would also use the money to strengthen security oversight, including the use of artificial intelligence and natural language processing to help CBER process “literally thousands and thousands – now almost millions – of adverse event reports that happen in any given year.”

Safety monitoring work related to COVID vaccines is made more difficult because patients saw far less of their primary care providers during the pandemic, and they received free vaccines that were not billed to insurance companies and therefore have no claims attached to them, says Marc. “It becomes very difficult to do safety monitoring because vaccination data is kept by vaccination information systems, and there are 60 of them scattered across the United States and its territories.”

“We basically had to work our way through agreements with each of those 60 so that our data partners could have access to the data needed to do the kind of security monitoring work that we would like to be able to do,” he added. . “So this is something we would like to address in the future, and it will require both funding and probably even legislative assistance.”

  • Joyce Frieden oversees MedPage Today’s coverage in Washington, including stories about Congress, the White House, the Supreme Court, professional health associations and federal agencies. She has 35 years of experience in health policy. To follow