NCHR Testimony on Talasoparib at the FDA Advisory Committee

May 21, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since the TALAPRO-2 trial shows Talzenna with Xtandi benefits castration-resistant metastatic prostate cancer patients with HRRm tumors but not those without, the FDA should not expand approval to HRRm-negative patients. The FDA Committee agreed.

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER 

We agree with other experts who expect that as head of CBER at FDA, Vinay Prasad will improve FDA approval standards by making it harder for unproven drugs to get FDA approval. Patients deserve to be able to rely on FDA to make sure drugs and biologics being sold in the US are safe and effective. Patients and physicians can’t make well-informed decisions if companies don’t do the research needed to provide clear evidence that a medical product is safe and effective.

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National Center for Health Research Public Comment Regarding FDA Draft Guidance for Industry: “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction” (Docket No. FDA-2007-D-0435)

NCHR supports FDA’s draft guidance on studies needed for drugs intended to help adults and children with obesity or overweight with serious health problems, but we urge the FDA to require studies of 3 years rather than 1 year to ensure that the drugs are effective attaining and maintaining weight loss. In our written public comment, we also recommended that FDA require the research to include possible side effects and complications of long-term use or of discontinuation of use; require prior non-drug interventions before enrollment in a study of a weight loss drug (especially for children), and more rigorously analyze dropout data to determine the causes and analyses of missing data. These changes are crucial to ensure that patients and clinicians have the evidence they need to make informed, safe, and effective decisions.

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NCHR Public Comment Regarding the FDA’s Draft Guidance for the Study of Sex Differences in the Clinical Evaluation of Medical Products

April 7, 2025: NCHR responded to FDA’s request for public comments regarding its guidance on sex differences in studies used as the basis for FDA approval. We strongly support most of the FDA’s proposed guidance, but we note that the agency’s has never required adequate representation of both sexes and so has failed to ensure that all drugs and devices approved for males and females are proven to have benefits that outweigh the risks for both males and females. If products are not adequately tested on a meaningful number of females and males, they should not be approved for females and males.

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