Letter to Senators on the Innovation for Healthier Americans bills -

We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).

Letter to Secretary of Department of Health regarding application of new Tobacco Control Act -

January 29, 2015 The Honorable Sylvia M. Burwell Secretary Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C. 20201   Dear Secretary Burwell: We are writing to affirm the public health importance of applying the new product provisions of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) to products […]

Chantix citizen petition -

October 8, 2014. Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928.