Patient and consumer advocacy groups criticized proposed device user fees as being too low and stressed the need for additional funding for post-market surveillance programs during a March 28 public meeting on device user fee reauthorization.

Under the medical device user fee agreement, reached by FDA and industry negotiators in February, the agency would collect $595 million in fees, plus inflation, from industry from fiscal 2013 through 2017 to meet new performance review goals and commitments outlined in a draft commitment letter and proposed legislative language released March 16. The total is about double the fees collected for the current five-year program. Under the agreement, user fees would make up 35% of FDA’s medical device pre-market review budget, up from the current 20%. (See Also see "FDA Sets March 28 Date To Discuss Newly Published Draft User Fee Pact" - Medtech Insight, 19 March, 2012..)

“It’s clear that the agreement reached by CDRH and industry reflects almost none of our comments and priorities,” said Kate Ryan, National Women’s Health Network.

Members of FDA’s user fee negotiation team met monthly with non-industry stakeholders, including patient and consumer advocates and clinical specialty societies, to provide updates on the concurrent reauthorization negotiations with industry, which lasted from January 2011 through February 2012.

However, several non-industry stakeholders at the FDA-sponsored public meeting said that their perspectives were not included in the final agreement, and called for a greater role in future reauthorization negotiations.

“It’s clear that the agreement reached by CDRH and industry reflects almost none of our comments and priorities,” said Kate Ryan, program coordinator with the National Women’s Health Network.

“Therefore, while we did find the meetings useful, we concluded that they did not enable us to have a meaningful impact on the negotiations. We will continue to advocate for Congress to establish seats at the negotiator table for patients and consumers so the concerns of these important stakeholders will be addressed in future reauthorizations.”

Many of the advocates said that CDRH would not receive enough resources from the user fees in the so-called MDUFA III agreement, and worried that the agency may have trouble meeting its performance goals with the limited funding provided.

“We are particularly concerned because lobbying continues to go on in Capitol Hill and efforts are being made to add more work and pressure on CDRH as part of MDUFA legislation,” said Diana Zuckerman, president of the National Research Center for Women and Families. “We don’t see how the resources available under the slightly increased user fees will be adequate for FDA to handle all of that additional work.”

Zuckerman also cited an article released online by Consumer Reports magazine March 28 titled “Dangerous Devices,” set to publish in the May issue of the magazine, which cites lack of clinical testing that has led to numerous post-market problems with surgical mesh, metal-on-metal hips and Allergan’s Lap-Band gastric banding system.

Consumers Union, which publishes Consumer Reports, says additional funding is needed for FDA to improve its regulatory process.

Post-Market Surveillance Concerns

Patient advocates were particularly critical of potential gaps in post-market surveillance, which did not receive any explicit increased allocation in the user fee agreement. Instead, the agency has said it will focus on improving its post-market programs “as resources permit.”

Ryan said that the National Women’s Health Network introduced proposals in the MDUFA III stakeholder meetings on methods to allocate user fee funding to improve the “passive surveillance” MedWatch program. The group also proposed using the fees to establish a unique device identifier system, as well including devices in FDA’s Sentinel post-market surveillance initiative.

“Despite our advocacy, the current agreement allocates no user fees for improvements to the MedWatch program. While we know the agency has plans to continue to improve it as resources permit, we know that’s difficult,” Ryan said.

“The agreement reached allocates no user fees to implement a UDI system nor [to] develop a plan to integrate devices into the Sentinel initiative,” she added.

“The outcome of these negotiations just did not focus on post-market surveillance,” said Malcolm Bertoni, FDA’s lead negotiator for MDUFA III.

A proposed regulation to establish a mandatory UDI system has been developed by FDA and is currently under review by the Office of Management and Budget.

The National Women’s Health Network and the National Research Center for Women and Families, among others, have endorsed provisions in a bipartisan Senate discussion draft bill that would require FDA to implement a UDI policy and integrate devices into the Sentinel initiative. (See Also see "Draft User Fee Bills Aim To Streamline And Strengthen Device Regs" - Medtech Insight, 19 March, 2012..)

Malcolm Bertoni, FDA’s assistant commissioner for planning and the lead FDA negotiator for MDUFA III, emphasized that the user fees will support the process of reviewing device applications, which includes “some targeted aspects of post-market surveillance.”

“The highest priority in these negotiations was to make sure that we put this user program on a sound financial footing and right structure for the goals to meet the pre-market review objectives,” he told “The Gray Sheet.”

“Because there was such a gap that we had to bridge between what FDA believed was necessary just to get that, versus what industry felt was necessary and what they were willing to pay, the outcome of these negotiations just did not focus on post-market surveillance,” he said.

Critique Of Third-Party Review Program

Several patient groups criticized FDA’s current third-party review program which can be used by companies to have some 510(k) submissions reviewed by outside accredited groups instead of FDA. The MDUFA III agreement would reauthorize the program for another five years, but it doesn’t allocate specific funds to the program and instead relies on funding it “as resources permit.”

“We think that the third-party review program should be scrapped altogether. It is FDA’s job to review safety and effectiveness of devices,” said Paul Brown, government relations manager for the National Research Center for Women and Families.

“Third parties have inherent conflicts of interest. They know that device makers can shop around to find the most lenient reviewer. Also, with third-party reviews, FDA often finds they are scientifically inadequate, which slows down the review process,” he said.

Ryan said that the National Women’s Health Network is also dissatisfied with the third-party review program. She said FDA has previously stated that nearly 60% of third-party reviews have quality issues.

“Given the cost of the program, and the acknowledgement that CDRH generally has to re-review the work of its third-party reviewers, this program clearly doesn’t accomplish its intended purpose – to better allocate resources and reach decisions more quickly,” she concluded.

FDA is accepting written comments on the draft medical device user fee reauthorization agreement through April 16.

Patient, Consumer Groups Decry Lack Of User Fee Funding For Post-Market Surveillance

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