The Fourth Circuit Court of Appeals has ruled that Durk Pearson and Sandy Shaw jumped the gun when they sued the FDA for declaratory and injunctive relief to prevent the agency from stopping them from publishing a US government study on the effectiveness of SAMe supplements in treating depression and arthritis.
SAMe is short for S-Adenosyl-L-Methionine, a biological compound present in all living cells and commonly sold as a dietary supplement. Durk Pearson and Sandy Shaw are the authors of Life Extension: A Practical Scientific Approach. They are also supplement makers and maintain a connection with the Life Extension Foundation.
In October 2002, the Agency for Healthcare Research and Quality (AHRQ), part of the U.S. Department of Health and Human Services (DHHS), published a report on SAMe entitled “S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease.” The objective of the report was to conduct a search of the published literature on the use of SAMe for the treatment of osteoarthritis, depression, and liver disease, and, on the basis of that search, to evaluate the evidence for the efficacy of SAMe.
It turns out that the search revealed sufficient literature to support the use of SAMe for two out of the three conditions, namely depression and osteoarthritis. In fact, the report concluded that supplements containing SAMe are more effective than placebos in the treatment
of depression and osteoarthritis.
Durk and Pearson, who have designed and sold SAMe supplements, wanted to publish the AHRQ report to validate the usefulness of this supplement ingredient. However, they were concerned that the FDA might take action against them to chill their first amendment right to distribute the SAMe report, and so they filed a lawsuit against FDA to prevent FDA from preventing Pearson and Shaw from distributing the report along side SAMe supplements.
Appellants feared that the FDA, under their administrative enforcement policy, would use the Publication as evidence of the “intended use” of the dietary supplements and reclassify Appellants’ SAMe-containing dietary supplements as “new drugs” under the Food Drug and Cosmetics Act (“FDCA”), thus prohibiting sale of the Publication to consumers.
Even though ripeness requirements are relaxed in First Amendment cases because of the potential chilling effect of unconstitutional restrictions on free speech, the district court dismissed the case as unripe and the Fourth Circuit affirmed. The Fourth Circuit held that the fact that the FDA had not threatened or implemented any procedures to either prohibit the sale of the Publication or to prosecute Appellants for FDA violations made the case not yet ripe for judicial determination.