Caroline Bradford

FDA official bolting to Big Tobacco shines a light on the agency’s revolving-door problem

Grid News, August 3, 2022: An FDA official leaving FDA’s Tobacco Science Office to work for Big Tobacco shines a light on the agency’s revolving-door problem. We explain why this undermines FDA’s authority.

Science says later school start times are healthier. Some High Desert schools aren’t so sure

Daily Press, August 1, 2022: Science says later school start times are healthier. We explain that “If you were designing something to make it very difficult for high school students to learn and concentrate, starting classes at 8 or earlier is what you would design.” But some students disagree.

Bipartisan bill on antibiotics faces crucial stretch

The Hill, August 1, 2022: A health care bill is facing criticism from some experts who say it could lead to huge spending on new antibiotic drug development that may not improve patient outcomes in the long run. We point out that it could increase antibiotic resistance rather than solve the problem.

NCHR Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer

The National Center for Health Research supports AHRQ's draft review finding that partial breast irradiation (PBI) is effective for select early-stage breast cancer patients, with most outcomes comparable to whole breast irradiation (WBI) at 5-10 years. NCHR emphasizes the need for additional research on different PBI types and long-term outcomes at 15-20 years, particularly across diverse patient populations.

NCHR’s Testimony on the FDA’s Proposed Reclassification of Computer-Aided Devices which Provide Adjunctive Diagnostic Information about Lesions Suspicious for Melanoma from Class III Devices to Class II Devices

July 29, 2022. We do not support the proposed reclassification of the two skin lesion analyzers, MelaFind and Nevisense, from Class III to Class II. We have 2 major concerns: There is no guarantee that newly developed devices cleared through the 510(k) process would be as accurate as those currently on the market. For that reason, newly developed devices should be reviewed through the PMA process and there is a clear risk of false positive and false negative results, misuse, and device failure, and the FDA has not provided adequate evidence that these risks can be adequately mitigated with the Class II special and general controls listed in the executive summary. As described, FDA cannot ensure that there will be reasonable assurance of safety or effectiveness over the lifespan of the newly submitted devices.