Burr chastises FDA at second Senate user fee hearing

Regulatory NewsRegulatory News | 26 April 2022 |  By 

Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.
On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to answer questions about the user fee deals reached with industry over the past year. In his opening remarks ranking member Burr again berated Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) for failing to submit its MDUFA V commitment letter with industry by 15 January as mandated. (RELATED: User fee reauthorization marches on with first Senate hearing, 5 April 2022 Regulatory Focus)
“Not only will FDA be three months late in finalizing an agreement, it took so long because you refused to acknowledge that the agency didn’t meet all its goals from the last time around,” he said. “And now, the FDA wants double the money for mediocre performance improvements, and for certain devices, longer review times.”
He further criticized the center for failing to explain to sponsors why they received deficiency letters, accruing a carryover balance from MDUFA IV “the size of a whole year of user fees,” and failing to finalize a critical guidance.
“More money, lower expectations of accountability, no accountability for past failures. Add on top of this, a new costly program aimed at shepherding certain devices through the review process for which FDA has zero clear deliverables … and you expect Congress to rubber stamp these agreements?” Burr asked. “My friends, I don’t think so… I know you can do better.”
In his opening remarks Shuren again apologized for the delay in getting the user fee deal to lawmakers stating that the agency was overwhelmed with COVID-19 related work. He also said the investments in past MDUFA programs have paid dividends in bringing new products to market, and that the new proposed user fee program does that and more.
"I want you to know that I personally regret that we missed the statutory deadline to deliver our recommendation to Congress,” said Shuren. “An obligation that I and the entire agency take seriously."
However, he said the long deliberations has produced a strong, thoughtful agreement that if enacted would continue to promote medical device innovation while increasing accountability for the program and maintaining FDA's standards.
Burr also noted that by law FDA is required to post meeting minutes with industry before the agency sends its MDUFA commitment letter to Congress so lawmakers can understand it within the context of the negotiations. The agency had not posted any meeting minutes since June 2021 and only in the past five days has it scrambled to post the remaining meeting minutes up to March.
Shuren explained that FDA couldn’t post meeting minutes until they had been negotiated and approved by the medtech industry for publishing as well.
"It is a negotiation of itself with the industry parties and you've seen how those negotiations go, a lot of diverse opinions,” he explained. “And the big focus was to get the deal done and get the minutes afterwards."
Shuren also said it was challenging for FDA and industry to direct resources to address meeting minutes due to the pandemic. He added that he planned to have the final MDUFA V package to Congress by the end of next week.
Burr further noted that he doesn’t agree with the total product lifecycle advisory program (TAP) that FDA has proposed, and that industry has agreed to pilot through the MDUFA V deal. He seemed skeptical of the idea and asked how the agency plans to measure its success so that lawmakers don’t just have to rely on FDA’s word.
"What performance goals do you want us to put in the statute," he asked of Shuren.
Shuren said he think what's in the commitment letter is a good start and plans to look at how the pilot program performs.
The CDRH director defended the TAP program by stating stakeholders are typically focused on the premarket review part of getting a product to market but the most important time is everything that leads up to that moment. The TAP program is meant to address questions in the product development process so that not only can it get to market but can get reimbursement once there.
On a less contentious note, Burr told Shuren that he and HELP committee Chair Sen. Patty Murray (D-WA), have been working on the Verifying Accurate Leading-edge IVCT Development Act to give FDA explicit authority to regulate laboratory developed tests (LDT) and asked if he agreed with their approach.
Shuren has long advocated for FDA to increase its oversight of LDTs that have become more complex and riskier over the decades since the agency decided to exercise its enforcement discretion toward them.
In response to Burr’s question, Shuren said he agreed with what Burr and Murray were doing and thanked them for their work.
Burr’s criticism however wasn’t only directed at CDRH. He also criticized the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) for stating they had met the Prescription Drug User Fee Act (PDUFA VI) hiring goals. He also asked why the centers don’t account for net vacancies.
The senator noted that FDA had committed to hiring 230 new staff members under PDUFA by 2022 but according to the agency’s own 2021 fiscal report it had only hired 212 while there are still 260 PDUFA vacancies across the two centers.
CDER Director Patrizia Cavazzoni explained that it is important to look at the hiring numbers in the context of the total staffing. She noted that currently the vacancies represent 7-8% of total staff which isn't an unexpected rate of vacancies or attrition for a large organization.
"We are overall on track to meet our commitments by the end of the [PDUFA] cycle, and yes, we are asking for additional personnel as part of the next cycle," said Cavazzoni. She said the additional personnel are meant to support incremental activities agreed between the agency and industry.
"I've been here for 28 years but I still don't buy into the belief that if you hire 212 people under the commitment and you still have 260 vacancies, that I as an applicant should feel good about that,” Burr responded. “That tells me there are less people working on applications."
He also argued that FDA didn't really accept foreign data into consideration for product reviews until the pandemic and hoped that this is an impetus for the agency to continue accept more foreign data.
Despite his finger wagging, Burr showed his appreciation for FDA’s work during the pandemic.
"I think you guys deserve tremendous amount of credit for going through two and a half years of hell, every center," he said.
Murray asked CBER Director Peter Marks why there was a delay in authorizing COVID-19 vaccinations for children under 5 and when the public can expect FDA to allow those children to receive vaccines.
Marks didn’t explicitly say the delay was because vaccine manufacturers haven’t completed their emergency use authorization (EUA) requests for the cohort but said the agency is prioritizing the matter and will move as quickly as it gets a complete application.
He did hint that was the case however by stating that whenever a company completes their EUA request, they will typically put out a statement on the achievement which none of the vaccine makers have done so far.
Sen. Maggie Hassan (D-NH) also criticized FDA during the hearing for not breaking ties with management company McKinsey due to its parallel work with opioid drug-maker Purdue. She argued there was a conflict of interest that the agency should have spotted sooner to end contracts with the company and asked what the agency was planning to do moving forward.
In response Cavazzoni noted that McKinsey didn't work on anything related to opioids at FDA where they could have any influence and was allowed to work for the agency based on current federal contracting guidelines that require contractors to self-report conflicts of interest. She also noted that McKinsey currently doesn’t have any contracts with CDER.
"We anticipate further contracts will not be issued pending the outcomes of the investigation," Cavazzoni said.
The answer however wasn’t satisfactory to Hassan who said relying on contractors to self-report any conflicts of interest may not be sufficient and was looking forward to working with other lawmakers to correct that.
Sen. Jacky Rosen (D-NV) noted that cyberattacks on health care systems have been increasing and said she plans to propose legislation with Sen. Bill Cassidy (R-LA) that would bolster collaboration between federal agencies to improve medical cyber defense. She also talked about proposing legislation that ensures medical device cybersecurity guidances are up-to-date and nimble.
Rosen also asked Shuren if FDA had considered updating guidances more frequently and whether they have the authority to do so.
Shuren agreed with her assessment that cybersecurity threats have increased and called it a national security issue. He said FDA wants to keep cybersecurity guidances fresh and in the agency’s budget proposal has asked for more funding for cybersecurity. He also asked for more authority to ensure FDA can require medical device makers produce secure devices.
Several senators, including Sen. John Hickenlooper (D-CO), asked FDA about their recent controversial decision to approve Aduhelm (aducanumab) and asked how Congress can enhance the agency’s transparency especially in situations where FDA’s decision doesn’t line up with recommendations from its advisory committee.
Cavazzoni didn’t directly address the issue but said FDA doesn't have authority to require companies to start a confirmatory trial by the time a drug is approved or require the sponsor to provide detailed plans to conduct those trials based on agreed upon timelines and milestones. She said FDA could also use extra authorities to require expediting withdrawal of drugs that do not show clinical benefit in the confirmatory studies.
"Right now the expedited withdrawal path is anything but expedited,” said Cavazzoni. “It will take years, it will require lots of resources and lots of administrative burdens. We could use help in shoring up the accelerated approval tool you have given us in those two areas."
Cavazzoni did however note that there are hundreds of pages that FDA has published that lays out its rationale for approving Aduhelm and a website that lists surrogate endpoints the agency used in the decision much of which were based on data from other similar drugs that were in development.


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