Supreme Court Decides Wyeth Case

admin Constitutional Law, Health Law

The Supreme Court ruled by a 6 to 3 vote that approval of a drug by the Food and Drug Administration (FDA) does not prohibit a state court jury from finding a pharmaceutical manufacturer liable for personal injury caused by the inadequacy of an FDA-approved warning label on that drug. We had filed an amicus Read More

Wyeth v. Levine Amicus Brief Filed in the U.S. Supreme Court on Behalf of The Senior Citizens League

admin Constitutional Law, Health Law, U. S. Supreme Court

On behalf of The Senior Citizens League (“TSCL”), we filed an amicus curiae brief in the Supreme Court in Wyeth v. Levine (Supreme Court Docket No. 06-1249) on behalf of the respondent, Diana Levine. The issue in this case is whether approval of a drug and its labeling by the Food and Drug Administration Read More

TSCL Comments on FDA Report “FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology”

admin Administrative Law, Health Law

On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s Science Board Report Entitled “FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.”

The Report asserts that the FDA is in danger of not being able to perform its mission without a vast and unprecedented doubling Read More

Abigail Alliance Case — Amicus Brief Filed In U.S. Supreme Court for The Seniors Citizen League

admin Constitutional Law, Health Law, U. S. Supreme Court

Today we filed an amicus curiae brief in the Supreme Court in the case of Abigail Alliance v. VonEschenbach, Commissioner of the FDA.  The U.S. Supreme Court had been asked by an alliance of terminally ill patients with no conventional medical alternatives to overturn an en banc decision of the U.S. Court of Appeals for the D.C. Circuit which allows the FDA to bar these patients’ access to certain Read More

TSCL Comments on FDA Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims

admin Administrative Law, Health Law

On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s  “Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims”.

The FDA Draft Guidance asserts that the FDA is authorized by the NLEA to treat health claims for both conventional food and health Read More

FDA Draft Guidance for Industry on Complementary and Alternative Medicine

admin Administrative Law, Health Law

Today, on behalf of TREA Senior Citizens League, we filed with the FDA for both Clarification of, and Extension of, the deadline for comments in response to the FDA’s rulemaking in Docket No. R2006D-0480, entitled “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by Food and Drug Administration.”

Link to request