Letter to House Members Opposing Language Added to the Appropriations Bill that Lowers the FDA’s Safety and Efficacy Standards for Drugs and Devices

April 15, 2016. The National Center for Health Research strongly opposes language added at the last minute to the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language lowers the FDA’s safety and efficacy standards for approving drugs and medical devices and will put the public health at risk. These are the same provisions that members of the Patient, Consumer, and Public Health Coalition have previously opposed. We urge you to oppose including in the appropriations bill language that lowers FDA’s standards for drugs and devices.

Read More »

NCHR Testimony at 2016 FDA Meeting on Rociletinib

April 12, 2016. NCHR realizes that there is currently an unmet need for a drug to treat patients whose NSCLC has become resistant to first line TKI therapies via the T790M mutation. However, this does not warrant the approval of yet another drug that will not significantly improve outcomes for these patients. Fortunately, there is hope on the horizon, because the preliminary results for osimertinib for the same patients appears to be much more effective with fewer serious side effects.

Read More »

NCHR Supports Proposed FDA Regulation of Sunscreens

March 25, 2016. NCHR strongly supports the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. The proposed testing requirements for new sunscreen chemicals will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm.

Read More »