A similar version of this letter was sent to Senators Alexander and Murray of the Senate Health, Education, Labor, and Pensions (HELP) Committee, majority leader McConnell, minority leader Schumer, and members of both the Appropriations and HELP Committees.
January 11, 2019
Chairman Richard Shelby and Vice Chairman Patrick Leahy
Washington, DC 20510
Dear Mr. Chairman and Mr. Vice Chairman:
I am writing to you on behalf of the National Center for Health Research to alert you to the dangerous situation facing all Americans as a result of the lack of FDA funding for post-market surveillance and safety evaluations during the current government shutdown.
As you know, during the shutdown the FDA is funded through user fees and the only staff that are allowed to work are focused on the review of new products in compliance with the performance goals (timely review) required by user fees. The medical device user fees are not used for post-market surveillance activities. The drug user fees are almost entirely used for premarket review, and there has been no public announcement of whether any post-market activities for prescription drugs or biologics are underway for the last three weeks. The situation will remain dangerous throughout the shutdown. When the Congress eventually passes legislation to provide appropriations for the FDA for FY 2019, it is inevitable that there will be an enormous backlog that will also undermine patient safety. The longer the shutdown, the more dangerous the situation will be during the shutdown and the more challenging the backlog will be.
Post-market surveillance is especially important for medical devices because the pre-market standards for approval or clearance are so much lower than they are for prescription drugs. While all prescription drug approvals are based on at least one pivotal clinical trials, less than 5% of medical devices are required to have submitted clinical trial data to get on the market. Even the highest risk (PMA) devices do not always submit clinical trials of their own devices when seeking approval. Of those approximately 5% that submit clinical trials, the vast majority of those trials are not randomized double-blind clinical trials, even though that is the gold standard for clinical trials. In fact, many of the PMA device trials have no active control groups to compare with the patients with the new device, and therefore provide very limited information about either safety or effectiveness. As a result, very little is known about the safety or effectiveness of new medical devices except through post-market information, which may include:
- Adverse event reports (mandatory and voluntary)
- Required post-market clinical trials, such as the study FDA has required for Essure
- FDA Advisory Panel meetings to review devices already on the market (such as the meeting that the Commissioner announced would be held early this year to review breast implants)
- Registries of patients with implanted devices (such as knee and hip joints)
- Formal or informal studies conducted by concerned physicians, investigative reporters, and other non-industry researchers that are reported in the media or submitted to the FDA as part of citizens’ petitions. Although the studies themselves are not part of the FDA surveillance activities, these studies are additional safeguards if FDA reviews them and responds by considering issuing a warning to physicians or patients or a device recall.
The impact of the shutdown on drug or device safety surveillance by the FDA has not been mentioned in the media or, to our knowledge, by Members of Congress. As you know, food safety efforts are greatly limited during the shutdown. Fortunately, the Center for Tobacco is entirely funded by user fees so that their work has not been affected.
The National Center for Health Research (NCHR) is a non-profit organization that analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from the drug or medical device industry and have no conflicts of interest on these matters. We have published several groundbreaking studies pertaining to FDA recalls of medical devices, and lack of safety data, including problems with cybersecurity and recalls of faulty medical software. Delays in high-risk recalls will clearly put patients’ lives at risk during the shutdown and while FDA attempts to deal with the backlog when appropriations become available.
The Senate will be part of the solution by immediately passing legislation to fund the FDA.
Please contact me with any questions at (202) 223-4000 or email@example.com .
Thank you for your commitment to patient safety.
Diana Zuckerman, Ph.D.