FDA UPDATE: Our Suit Against the FDA

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 9 No. 1 • January 2006


FDA UPDATE:
Our Suit Against the FDA, Case No. 05-1937 Before the United States Court of Appeals for the Fourth Circuit

You may already know about our suit against the FDA that argues that the agency’s threats of prosecution against us (Pearson and Shaw) for distributing a government report on the benefits of SAMe (S-adenosylmethionine) is a violation of our First Amendment rights to communicate and the First Amendment rights of the public to receive truthful scientific information. Incredibly, the FDA doesn’t argue that there is anything untruthful or misleading about the report from the federal Agency for Healthcare Research and Quality1 on SAMe’s usefulness in treating osteoarthritis (about as effective as the commonly used prescription drugs, though by a different mechanism) and depression (again, about as effective as commonly used prescription drugs, also by a different mechanism). They argue instead that distributing the information proves by their “intended use” doctrine that we are selling SAMe as a treatment and, hence, an unapproved drug. (Also in their arguments, in apparent contradiction to this, they argue that, well, maybe they won’t prosecute us if we communicate the information, but they haven’t decided yet. In fact, however, an affidavit from the FDA’s chief of labeling enforcement directly threatens our exercise of our First Amendment rights by declaring, under oath, that in his opinion the SAMe sold under our names by Life Extension Foundation is an unapproved drug.)

The district court’s decision went against us. The judge accepted the FDA’s incorrect claims that the case was not ripe (i.e., that we hadn’t suffered any injury). However, in First Amendment cases, the requirement generally to show injury in a lawsuit is relaxed, as it is recognized that one shouldn’t have to take an action that puts one in jeopardy of prison and fines in order to exercise one’s First Amendment rights. As noted in our closing brief, “It is the threat of prosecution that causes the harm.”

This is a very important case. If there is to be a large future for dietary supplements and foods to prevent and even treat disease, it has to be possible to communicate truthful, nonmisleading information concerning these uses, including the distribution of peer-reviewed scientific papers and government reports. Otherwise, only that small minority of the public that is exceptionally well read will know about these effects, and the industry will remain small, with few resources of its own for natural products research.

You can find our latest brief at www.emord.com. It is a brilliant brief that cuts through the lies and misinformation of the government’s brief and made our case with astonishing clarity and conviction. (If we do not get a good decision from the court, it will be due to the court’s failure, not that of our briefs.) If, after reading it, you appreciate this extensive effort that, if we win, will benefit you as much as ourselves, please send in any amount (no matter how small) to the Pearson & Shaw Litigation Fund, c/o Emord & Associates, 1800 Alexander Bell Drive, Suite 200, Reston, VA 20191.

Reference

  1. S-Adenosyl-L-methionine for treatment of depression, osteoarthritis, and liver disease. Evidence Report/Technology Assessment No. 64, Agency for Healthcare Research and Quality, U.S. Dept. of Health and Human Services, www.ahrq.gov.

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