National Center for Health Research

Research

In February 2011, NCHR staff completed a study on the various alternative approval processes for medical devices at the Food and Drug Administration (FDA). Authors associated with the NCHR published a study examining how often the different approval or clearance processes were used for medical devices that were subsequently recalled for life-threatening problems. The study resulted in a hearing by the U.S. House of Representatives that debated the safety of medical devices and the reason for high-risk recalls. The House hearing featured testimony from the NCHR study co-author, Dr. Steven Nissen of the Cleveland Clinic, and cardiologist Dr. Rita Redberg from University of California, San Francisco, who had published an editorial supporting the findings of the NCHR study.

In April 2011, NCHR President Diana Zuckerman testified before the U.S. Senate Special Committee on Aging about the study's findings at a hearing on medical devices.

In 2014, the organization published a study in the JAMA Internal Medicine journal about the scientific evidence submitted to the FDA to support the marketing of implanted medical devices under the agency's 510(k) review process. The study concluded that most of the implanted devices were not required to submit data from clinical trials or scientific evidence of safety or effectiveness before they could be sold.

In 2017, the NCHR staff published a paper in Milbank Quarterly criticizing the FDA for its failure to safeguard electronic health records and other device software from hacking and other cybersecurity threats. They stated, "Current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market". They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients."

The NCHR published another study in Milbank Quarterly in 2018 called "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?". The study investigated whether new, high-risk medical devices had been proven safe and effective for women, minorities, or patients over 65 years of age. The paper concluded that most studies did not conduct subgroup analysis on all these major demographic groups, thus providing no information about safety or effectiveness for most patients.

In 2021, NCHR published an article in the American Journal of Public Health entitled, "Emergency Use Authorizations (EUAS) Versus FDA Approval: Implications for COVID-19 and Public Health", explaining how FDA's emergency pathway was used by the agency to rapidly respond to the need for diagnostic tests, treatments, and personal protective equipment during the COVID pandemic, in ways that were sometimes beneficial but also resulted in inaccurate test results and products that were later found to be ineffective.

Awards

Two awards are given by the Center each year:

• The Foremother Lifetime Achievement Award "recognizes women who expanded women's horizons, improved our communities, and made remarkable contributions to our country".
• The Health Policy Heroes Award "honors men and women (and sometimes boys and girls) who have changed the public debate and public policies in ways that help to improve the lives of adults and children nationwide".

Publications

References

References

1. "Home Page".
2. (2018-05-07). "The National Center for Health Research - National Center for Health Research".
3. "S.Hrg. 112-92 — A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS".
4. "STIFLING INNOVATION: EXAMINING THE IMPACTS OF REGULATORY BURDENS ON SMALL BUSINESSES IN HEALTHCARE".
5. "POLITICO Pro: Pfizer hires FDA drug regulator Cavazzoni, sparking revolving door debate".
6. Jewett, Christina. (2024-10-22). "F.D.A. Names a New Chief of Medical Devices". The New York Times.
7. Gilbert, Daniel. (March 16, 2024). "Failure of ALS drug puts a spotlight on controversial FDA approvals". The Washington Post.
8. (13 June 2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine.
9. "IMPACT OF MEDICAL DEVICE REGULATION ON JOBS AND PATIENTS".
10. Miller, Reed. (February 18, 2011). "Debate on 510(k)s and Recalls Reaches Capitol Hill".
11. "S.Hrg. 112-92 — A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS".
12. National Center for Health Research, NCHR. (2011-04-13). "Testimony of Dr. Diana Zuckerman at Senate Special Committee on Aging Hearing on Medical Devices - National Center for Health Research".
13. Jin, Jill. (2014-01-22). "FDA Authorization of Medical Devices". JAMA.
14. (September 2017). "Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health". The Milbank Quarterly.
15. (September 2018). "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?". The Milbank Quarterly.
16. Zuckerman, Diana M.. (2021-05-05). "Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health". American Journal of Public Health.
17. (7 May 2018). "Foremother and Health Policy Hero Awards Luncheon". National Center for Health Research.