Daniel Chapter One Brief of Petitioners

Michael Harless Health Law, U. S. Court of Appeals, District of Columbia Circuit

On behalf of Daniel Chapter One (“DCO”), today we filed with the U.S. Court of Appeals for the D.C. Circuit the brief of petitioners. The DCO brief argues that the FTC failed to establish jurisdiction over DCO and exceeded its statutory authority by misuse of its “reasonable basis” theory and test. Further, the FTC order is arbitrary and capricious, being the product of a Read More

Daniel Chapter One Motion for Hearing on RFRA Claim

Michael Harless Health Law, U. S. Court of Appeals, District of Columbia Circuit

On behalf of Daniel Chapter One (“DCO”), today we filed with the U.S. Court of Appeals for the D.C. Circuit a motion requesting a hearing on DCO’s claim that application of parts of the FTC’s modified final order substantially burdens DCO’s exercise of religion in violation of the Religious Freedom Restoration Act (“RFRA”).

Link to motion

Bill Olson Interviewed on Conservative Roundtable TV Show on Health Freedom Issues

Michael Harless Appearances, Health Law, Press Coverage

Bill Olson was a guest on Conservative Roundtable’s Television show to discuss health freedom issues. Among the matters discussed was the Daniel Chapter One case, where our firm is assisting in the defense of a health-related ministry promoting herbal and alternative medical products from an attack by the FTC. Information about the FTC attack on this ministry.

Link to video

Supreme Court Decides Wyeth Case

Michael Harless 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

Michael Harless 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 preempts Read More

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

Michael Harless 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

Michael Harless 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

Michael Harless 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

Michael Harless 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