December 16, 2013. When notorious and decades-known carcinogens such as asbestos and radon are still present at unsafe or unknown levels in American workplaces, how can the public have confidence that our regulations can handle new and complex occupational hazards arising every day? Only a few hundred out of more than 80,000 chemicals in use in the United States have been tested for safety. We should be concerned.
Thank you for the opportunity to speak today on behalf of the Cancer Prevention and Treatment Fund. My name is Dr. Anna Mazzucco, and after completing my Ph.D. in Cell and Developmental Biology from HarvardMedicalSchool I conducted research at the National Cancer Institute. I bring those perspectives today.
The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis. Greater diversity in clinical trials, analyzing subgroup data, and reporting the results and explaining the implications in product labels and MedGuides will shed light on which medical products are safe and effective for which demographic subgroups, including racial and ethnic minorities.
November 20, 2013. We welcome the opportunity to comment on the FDA’s guidance to industry on preclinical detection of endocrine disruption potential in drug and biologics applications.
November 2013. We write today to urge the FDA to remove menthol cigarettes from the market as quickly as possible. A conservative modeling scenario published in a peer-reviewed medical journal estimated that over 320,000 deaths could be averted by 2050 had menthol been banned in 2011 as recommended. The FDA must not drag its feet any longer.
We agree with the Task Force that at this point, there is no reason to recommend virtual colonoscopies for most patients who need screening. We would add, however, that if specific patients are unwilling to undergo regular colonoscopies, then a virtual colonoscopy is a reasonable alternative.