Thank you for the opportunity to speak today. I am Dr. Christina Silcox, I have a PhD in Medical Engineering and Medical Physics from MIT and Harvard Medical School, and I am a senior fellow at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. These are the perspectives I bring here today.
MDUFA should protect the public health by improving the safety and efficacy of all medical products, whether PMA or 510(k). That requires higher user fees, performance standards that focus on the quality of the review and not just the speed, and reviews that provide patients, consumers, and healthcare providers with information about how well the product works compared to other similar products on the market.
The new MDUFA legislation should:
- Substantially increase the FDA resources for both 510(k) reviews and PMAs.
- Require higher standards of safety and effectiveness for devices that can potentially sustain life, save lives, or harm lives. They should be held to at least as high as standards for prescription drugs.
- Focus on safety and ensure that only safe predicate devices can be used for the 510(k) clearance process.
- Focus on post-market surveillance of all medical devices.
A major concern is that the medical device user fees are too low to adequately support the Center for Devices and Radiological Health’s (CDRH) efforts to clear or approve safe and effective medical devices in a timely manner.
Although the PMA and NDA process are similar, the FDA charges much smaller user fees to review medical devices than it charges to review prescription drugs, even when the same companies make devices and pharmaceuticals. The simple fact is that the user fees for 510(k) reviews and for Premarket Approvals (PMAs) are a small fraction of the actual cost of the reviews. This exacerbates the lack of resources at CDRH. For example, currently the FDA charges a standard fee of only $5,018 for a 510(k) submission (half that amount for small companies) and $250,895 for an original PMA (one-quarter that amount for small companies), compared to user fees ranging from $1.2 to $2.3 million for a New Drug Application (NDA).
The user fees for PMAs and NDAs should be comparable. Why should a drug that prevents clods from forming have a $2M user fee while a device that does the same have a fee that is less than a quarter million dollars?
The inadequacy of the fees for the 510(k) is especially egregious. User fees of only a few thousand dollars do not provide the FDA the resources needed to assure the safety and effectiveness of medical devices reviewed through the 510(k) process.
And now we are talking about using user fees for post-market surveillance as well. $5000 certainly does not provide resources for robust post-market surveillance.
And with 21st Century Cures, we have the potential for third-party reviews of PMAs. This would eliminate supplemental PMA user fees, leaving nothing for post-market surveillance of those devices.
The argument can be made that Congressional appropriations should fill in the difference. But we can see with 21st Century Cures that Congress is not willing to do so. They appropriated less than a third of the amount of money that would be needed to implement all the reforms required in that bill.
Another concern is ensuring higher standards for safety & effectiveness.
Part of the MDUFA improvements should be the assurance that a device will not be cleared as “substantially equivalent” to a previously recalled device, or to a device that was cleared on the basis of a predicate device that was substantially equivalent to a recalled device.
In conclusion, reauthorization of MDUFA gives Congress and the FDA an opportunity to strengthen CDRH by increasing its resources, holding medical devices to higher safety and effectiveness standards, and ensuring that predicate devices cited for new devices are safe.
Thank you for the important work that you do on behalf of the public health, and thank you for your consideration of our views.