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

Daniel Chapter One Application for Stay

Michael Harless Administrative Law, Health Law

Today we filed an Application for Stay with the Federal Trade Commission, asking the Commission to stay its Order of January 25, 2010 against Daniel Chapter One, pending review in an Article III court. The Application was supported by a Memorandum, a Proposed Form of Order, and the following declarations:

Declaration of James Feijo
Declaration of Patricia Feijo
Daniel Chapter One
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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 brief urging this view for The Senior Citizens League (TSCL). Justice Thomas’ Concurring Opinion reflected the views set out in the TSCL amicus brief that the Tenth Amendment secures to the states and the people common law rights that a federal agency, like the FDA, cannot trespass upon with impunity.
See TSCL Press Release. 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 state tort liability when the label as approved does not adequately warn of the dangers of certain forms of administration of a drug. 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 of funding. The Report admits that Subcommittee was “not [asked] to assess available resources,” yet it nevertheless focused on the inadequacy of current funding. The Report claims that American lives already are at risk because of work that the FDA has been unable to do, and that nothing would change without additional funding. 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 drugs, even after the FDA has approved them for Phase II testing. 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 claims for dietary supplements in virtually the same manner.  In 1990, Congress adopted a “significant scientific agreement” standard applicable to “conventional food health claims” and the FDA subsequently purported, by regulation, to extend that same standard to “dietary supplements health claims,” even though the statute provided that this standard did not apply to dietary supplements. 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 (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s  “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation”.  According to the Draft Guidance,  the FDA asserted that it had authority to regulate products utilized by practitioners of  Complementary and Alternative Medicine (“CAM”), with special emphasis upon its power to regulate vitamins, minerals, and dietary supplements as drugs, if those products were “intended” to be used by a CAM practitioners as part of a disease treatment program.  Additionally, the FDA stated in its Draft Guidance that it had the right to regulate products used in chiropractic and massage as medical devices.  If the Draft Guidance is adopted by the FDA, it could mean that ordinary foods — such as raw vegetable juice — would be subject to FDA “premarket review” just as is the case now for prescription drugs used in conventional allopathic medicine.  Further, if the Guidance were adopted, the FDA presumably would make substantial intrusions into the regulation of alternative medicinal practices traditionally left to the states. 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