Regulatory News In Brief

GSK pays GMP whistleblower fine

GlaxoSmithKline agrees to pay $750 million in a settlement with the Department of Justice to resolve whistleblower allegations of product mix-ups, microbial contamination and other good manufacturing practices violations at a plant in Cidra, Puerto Rico. The products, manufactured from 2001 to 2005, include the, the acid reflux reliever Tagamet, available OTC and Rx, and prescription products including anti-infective ointment Bactroban, Kyatril for nausea, Paxil for depression and Avandamet for diabetes. A former quality control manager, who alleges she was fired after bringing the violations to GSK’s attention, filed the suit under a federal law that allows citizens to file complaints on behalf of the government and share in any damages recovered (Also see "GMP Violations At GSK's Former Puerto Rico Plant Are Basis Of $750 Million DoJ Settlement" - Pink Sheet, 26 Oct, 2010.).

FDA seizes product from Tri-Med Labs

FDA makes good on its promise to follow warning letters with stronger enforcement action if firms fail to address quality and safety problems. The agency requested U.S. Marshals seize prescription and OTC drugs from Tri-Med Laboratories Inc. in Somerset, N.J., in October because the firm failed to comply with good manufacturing practices and "refused to take ... unapproved products off the market after it received warning letters," FDA said Oct. 27. FDA warned Tri-Med of repeat GMP violations in a Feb. 23 letter following a September 2009 inspection. Several violations were repeats from warnings in 2004 and 2008. An FDA official recently said the agency will warn firms only once – if at all – before seizing products and levying fines (" (Also see "FDA Issues More Warning Letters, Drops Follow-Up Letters In Favor Of Action" - Pink Sheet, 25 Oct, 2010.)). In addition to the GMP violations, Tri-Med inappropriately marketed prescription products as OTCs, including Pseud DM GG Syrup, Triall Syrup and Triplex DM liquid among others.

FTC files suit to stop diabetes claims

The Federal Trade Commission Oct. 28 asks a judge to bar permanently Wellness Support Network Inc. and principals Robert Held and Robyn Held from making unsubstantiated claims that their supplements treat and prevent diabetes. The products at issue, Diabetic Pack and Insulin Resistance Pack, include vitamins, minerals and plant extracts and were sold primarily online for $76.70 for a 30-day supply. FTC alleges some claims are false or unsupported by scientific evidence, including "Diabetic Pack is an effective treatment for diabetes," "Insulin Resistance Pack reverses and manages insulin resistance" and both products are "proven to cause an average drop in blood glucose levels of 31.9." The agency's complaint, filed in the U.S. District Court for the Northern District of California, also notes advertising relies on consumer testimonials, like one from a user claiming to have lost 50 lbs. and stopped taking insulin. FTC officials have noted a particular focus on disease claims (Also see "FTC To Tailor Claim Substantiation Requirements To Each Case" - Pink Sheet, 4 Oct, 2010.).

Bayer settles One A Day case with states

An investigation into Bayer’s prostate health claims linked to the selenium in its Men’s One A Day multivitamins results in a settlement agreement in which the firm will pay $3.3 million to Oregon, California and Illinois. The Center for Science in the Public Interest announced the settlement Oct. 27. CSPI threatened to sue Bayer and requested regulatory action regarding the One A Day prostate cancer-prevention claims in 2009 (Also see "CSPI Calls On FDA To Make Example Of Bayer One A Day Selenium Claims" - Pink Sheet, 6 Jul, 2009.). Bayer stopped using prostate health language in marketing the multivitamin, and is barred from making claims unsupported by competent and reliable scientific evidence under its deal with the states.

Federal court slams coral calcium claims

An appeals court criticizes Direct Marketing Concepts and upholds a lower court's summary judgment that the defendants made unsubstantiated claims for coral calcium supplements. "We find no more substance in" the defendants' argument "than the district court found in their infomercials," in which they claimed cures for "literally every disease, from cancer to Parkinson's to obesity," according to the Oct. 21 ruling in the U.S. Court of Appeals for the First Circuit. The ruling on an FTC complaint affirmed the U.S. District for the District of Massachusetts' order that Beverly, Mass.-based Direct Marketing pay $50 million to reimburse customers. The defendants argued the fine exceeded their revenues and that research supports the claims, but the three-judge panel said their substantiation is "woefully inadequate" and their argument does not counter FTC's evidence. "We can make neither heads nor tails of these citations, which have no clear relevance and which are completely devoid of context or developed argument," the ruling says.

FDA warns of tainted ED supplement

FDA warns Deerfield Beach, Fla.-based Natural Wellness that its MasXtreme, Passion Power for Men and Passion Power for Women sexual aids are unapproved new drugs, because they contain prescription drug ingredients and claims suggest they affect the structure or function of the body, according to an Oct. 5 letter from the agency's Florida district office. During an inspection in May and June, an investigator collected samples and labeling associated with the products, and found the formulas contain phentolamine, an active ingredient in FDA approved drugs for control of hypertensive episodes. MasXtreme also contained sildenafil, the active ingredient in prescription Viagra. Claims such as the formula improves “sexual performance, libido” and “stamina” exclude the products from the definition of a dietary supplement, the agency adds. Natural Wellness has 15 days from receipt of the letter to respond with information on adequate steps to correct the violations. The firm recalled MasXtreme ("Natural Wellness recalls MasXtreme," "The Tan Sheet" April 5, 2010, In Brief).