Comments to FDA on Regulatory Status of Vinpocetine

Michael Harless Administrative Law, Health Law

Today our firm filed comments with the FDA in response to a request for comment on its “tentative conclusion” that the ingredient vinpocetine does not meet the definition of a “dietary supplement.” Our comments explained that vinpocetine fits within the definition of “dietary supplement” as a “constituent of a botanical.” Then we analyzed the four statutory requirements for removal of a dietary supplement from the market, and in this case, at least two of these requirements have not been met. Finally, we addressed the ways in which vinpocetine has been beneficial to Americans with a wide variety of health problems, including symptoms of Alzheimer’s.

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Comments filed with FDA to Defend Compounding Pharmacists

Michael Harless Administrative Law, Health Law

An FDA Advisory Committee is considering imposing new and unnecessary limitations on what Compounding Pharmacists may use to create products that are needed by many people, especially seniors.  Remarkably, the FDA Advisory Committee is reported to have only one member who has experience with Compounding.  We filed comments for The Senior Citizens League and the Center for Medical Freedom with the FDA opposing these arbitrary limitations.

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Book: ‘Defining Drugs: How Government Became the Arbiter of Pharmaceutical Fact”

Michael Harless Administrative Law, Health Law, Publications

Bill Olson was honored to write the Foreword for the re-issuance of what may prove to be the most important book ever written questioning the authority of the federal government over the sale and use of pharmaceuticals.  Professor of Pharmacy Richard Henry Parrish II originally wrote his book, “Defining Drugs:  How Government Became the Arbiter of Pharmaceutical Fact” in 2003. Now issued in paperback with a new Introduction and new Foreword, Professor Parrish has charted the growing evidence of corruption in the FDA and FTC, and those agencies’ lawless assertion of power over all aspects of all substances and devices in any way related to healthcare.  This book is even more important now than when first written.

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Obamacare Contraception/Abortion Services Mandate Conestoga Wood Specialties Corp. v. Sebelius U.S. Supreme Court Amicus Brief

Michael Harless Constitutional Law, U. S. Supreme Court

The story is told of a grizzled Master Sargent who, reflecting on his years of service, said: “When I joined up, homosexuality was prohibited; now it’s tolerated; and I darn sure am getting out before it’s mandatory.” So it is with respect to homosexual and abortion rights. First, the goal is said to be tolerance. Then, governmental approval and support. Lastly, any pretense of tolerance disappears, and the coercive force of government is used to eliminate any vestige of opposition. The Obamacare contraception/abortion mandate demonstrates that our nation is at the end of phase two, moving into phase three.

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Federal Trade Commission v. Daniel Chapter One A Story of Government Suppression of Alternative Medicine

Michael Harless Health Law, Publications

Bill Olson and Herb Titus wrote “Federal Trade Commission v. Daniel Chapter One, A Story of Government Suppression of Alternative Medicine” which covers our firms representation of Daniel Chapter One, a historical perspective of the attack on alternative medicine, the federal assault on dietary supplements and alternative medicine, the story of Daniel Chapter One, and the litigation proceedings of the FTC’s abusive campaign against 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.

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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.

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.

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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.

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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.

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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.”

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