As members of the Patient, Consumer, and Public Health Coalition, we thank you for the opportunity to share our views on needed improvements to make MDUFA VI a more patient-centered, evidence-based program that improves the timely access to safer and more effective medical products. We are an informal coalition of more than 2 dozen nonprofit organizations that focuses on ensuring safe, effective, and affordable medical and consumer products. The Patient, Consumer, and Public Health Coalition does not accept funding from entities with financial ties to our work. Our nonprofit member organizations are key stakeholders that have been actively engaged in previous MDUFA reauthorizations and appreciate being able to share our perspective here today.
We support the reauthorization of MDUFA, but we strongly urge that MDUFA performance goals need to be more patient-centered and focused on quality rather than only on speed of reviews. We know that getting new devices on the market more quickly can be beneficial to patients, but not when there is no evidence that the devices are at least as safe and effective as other products on the market. Our coalition includes nonprofit organizations that have worked closely with patients who were harmed by medical devices, including patients who have lived with lifelong complications of chronic pain and loss of mobility from implants that were later recalled. Other patients have used devices that clearly did not work. Our coalition also includes healthcare professionals who know how difficult it is to make informed medical decisions when data are lacking and safety signals from adverse events or published studies are not evaluated in a timely manner.
MDUFA V and all the previous MDUFA commitments were negotiated by device industry representatives and the FDA behind closed doors. Other important stakeholders, such as patient advocates, consumers, health professionals, and public health advocates have been excluded from the process, and although we are briefed by the FDA periodically and have access to the minutes, that process provides only a vague summary of the negotiations and our feedback and requests have had little if any impact on the Commitment Letter, despite the fact that we are the ones selecting and paying for medical devices. In fact, the Commitment Letter for MDUFA V clearly conveys that the device industry is telling the FDA what they must do to receive user fees, rather than indicating that the FDA is the regulatory agency and industry must comply with its priorities. Stakeholders with a clear understanding of the workings of CDRH need to be at the table in order for our priorities to be an influential part of the process.
The MDUFA V Commitment Letter did not show an appreciation for the ways that timelines and access to FDA staff throughout the application process could reduce the availability of staff for other activities and thus undermine safety and effectiveness. Although some patients will benefit from earlier access to new devices, there is little evidence that this earlier access is more important than making sure that new devices are safe and effective in ways that benefit the patients, consumers, and health professionals who use medical devices. When standards for safety and effectiveness are weakened due to a lack of staff and unrealistic timelines, patients and their physicians must make important medical decisions without the information they need to make informed decisions about whether the benefits outweigh the risks for specific types of patients. At the same time that the patients are putting themselves at risk of ineffective or unsafe devices, they will have no legal recourse against the responsible parties if the devices are reviewed through the PMA pathway or if the devices are made by overseas manufacturers.
Premarket Reviews
There are 2 important ways that MDUFA user fees should be used to improve pre-market reviews:
Even prior to this year’s mass layoffs, CDRH had a critical shortage of subject matter experts (SMEs) in relevant subject areas (e.g., software, cybersecurity, electromagnetic compatibility (EMC), electrical safety, performance testing, and biocompatibility), as well as a shortage of compliance personnel who ensure that devices on the U.S. market are safe and effective. Due to the shortage of SMEs, medical device submissions were often reviewed by staff who had little-to-no expertise in many or any of the subject areas. Since staff were pressured to meet the strict deadlines imposed by MDUFA V and wanted to keep their jobs, many resorted to performing inadequate reviews, making guesses, and skipping sections, none of which were documented in the reviews. User fees are urgently needed to hire additional SMEs and compliance staff.
The FDA has stated that AI will help reviewers be more efficient, but any work done by AI needs to be carefully reviewed, because as is well documented, AI “aims to please” and sometimes does that by making up citations and other information that is inaccurate, misleading, or completely fabricated. We urge that any use of AI in regulatory review must include independent validation and rigorous human oversight, with public reporting on accuracy and reliability. However, one way that user fees can help make FDA reviews more efficient with AI or with staff is to improve CDRH policies regarding falsified test reports and submissions, referred to by the FDA as “data integrity issues.” Former FDA reviewers tell us that even when information is obviously false, reviewers are required to take considerable time and resources to deal with them unless they can prove them false beyond a shadow of a doubt – an unrealistically high standard, which exceeds that required for most court cases. Similarly, FDA reviews would save time if submissions that have obviously inconsistent information or wording could be rejected rather than thoroughly reviewed, when those problems are due to consistently poor translations to English or inappropriate editing when wording was borrowed for a submission for a different product.
Post-Market Oversight
Once device companies obtain 510k clearance or PMA approval to market their devices in the U.S., the companies are required to continue to track safety issues reported for their devices for as long as the devices are sold. Unfortunately, companies have little incentive to spend their resources on effective post-market surveillance, as becomes obvious when problems are identified due to lawsuits or recalls. In addition, there are millions of adverse event reports, and FDA staff usually only focus on deaths and severe injuries, not the malfunctions and other events that can cause harm to thousands of patients. That is why user fees need to cover post-market surveillance and compliance with any post-market revisions, research, or evaluations that the FDA requires. The standard fee for a 510(k), the type of submission used for more than 95% of medical devices, is $24,335 under MDUFA V, and many companies only pay the small business fee of $6,084. This is not sufficient for a thorough pre-market review and certainly could not pay for post-market reviews as well. There are three ways to solve this problem:
- Stricter criteria to qualify as a small business.Many device companies meet the current criteria for qualifying as a small business. Consequently, few companies pay full user fees. We agree that truly small U.S. companies should pay less than larger companies, but some companies that pay the fee as a small business are not so small that a fee of $25,000 is burdensome. We also recommend that businesses that are not U.S.-based should not be eligible for the small business fees. Temporary exceptions could be made as needed to address shortages of medically necessary devices.
- User fees can be increased dramaticallywithout significantly increasing the per-unit cost of the device. For example, if the user fee for a 510(k) increased by $10,000, a company that manufactures 100,000 devices for the life of their 510(k) would only need to charge an additional $0.10 per device to offset this cost.
- A separate user fee for device post-market surveillance would only be paid by companies whose devices have been cleared or approved for market, so that those user fees provide the resources FDA needs to ensure that any safety or effectiveness issues that arise once the devices are on the market are identified and addressed in a timely manner.
Improving MDUFA VI would greatly benefit patients and consumers and would also benefit reputable device companies with better quality control systems whose products are competing against companies that are not paying to have their devices tested by reputable testing labs. It is not possible to improve the health of all Americans without improving the resources available to ensure the safety and effectiveness of medical devices that so many Americans rely on.
In conclusion, we urge that MDUFA VI prioritize patient safety over speed, ensure meaningful stakeholder participation in negotiations, and strengthen both pre- and post-market oversight. Only then can it deliver on its promise to protect and improve public health.
Sincerely,
Cancer Prevention and Treatment Fund
DES Action
Jacobs Institute of Women’s Health
Medical Device Problems
MedShadow
MRSA Survivors Network
Our Bodies Ourselves
Patient Safety Action Network
SCAD Alliance
TMJ Association
USA Patient Network
Washington Advocates for Patient Safety
Woody Matters