"OPERATION Rx" SEARCH WARRANTS TARGET 100 "ILLEGALLY" DISTRIBUTED DRUGS; TWO-YEAR PROBE EXPECTED TO SEIZE "MILLIONS OF DOLLARS WORTH" OF PHARMACEUTICALS
A two-year multi-agency state and government probe has resulted in search warrants targeting 100 drugs distributed "illegally," FDA said May 12. The 37 search warrants executed May 12 focused on 11 pharmaceutical distributors in seven states, the agency said. The probe, called "Operation Rx," is being coordinated by the U.S. Attorney's office in San Diego; 23 of the search warrants were served in California. No charges have been filed in relation to the investigation while the findings of the searches are being inventoried and documented. However, the California Food and Drug Branch said it expected the value of the seized drugs to be "in the millions of dollars." FDA said Operation Rx is "ongoing" and "will continue for a lot longer." Further searches will be announced, as will the results of the May 12 seizures. The warrants allowed for the search of 11 companies "and other places for evidence of wrongdoing," the California Food and Drug Branch said. The businesses are: Hospital Santa Monica; HSM Service Company; Pharmaceuticals International; International Pharmaceuticals; World Pharmaceuticals; Global Trading; Global Medical Information Services; Universal Metabolics; Universal Pharmaceuticals; Medigan; and Medicina Future. The search warrants for Operation Rx include charges of mail fraud, money laundering, smuggling, drug misbranding and introducing unapproved and misbranded drugs into interstate commerce. All 11 companies are suspected of being involved in dispensing prescription pharmaceuticals without prescriptions, principally by mail-order. Other suspected activities include manufacturing unapproved drugs in the U.S. and importing unapproved drugs from Mexico and possibly other countries. Several of the products listed in the warrants are frequently prescribed drugs, such as Ciba-Geigy's Voltaren and SmithKline Beecham's Tagamet, that were allegedly dispensed without prescriptions. Other products targeted by the search warrants were apparently being sold under slightly modified brand names: for example, "Teldane" and "Seldene," apparently relabeled versions of Marion Merrell Dow's Seldane. The California Food and Drug Branch said that some of the targeted drugs "contain potent ingredients such as anabolic steroids, conjugated estrogens and the anticonvulsant phenytoin, that can cause harm if their use is not carefully monitored under medical supervision." Other drugs listed in the warrants contain unapproved ingredients or the anesthetic procaine instead of the labeled active ingredient. Preliminary FDA testing of drugs obtained through the mail by undercover agents found examples of subpotency, superpotency, adulteration, and drugs that contained no active ingredient. For example, a sample of the prostate cancer drug flutamide was found to contain 69% of the labeled potency, while a version of Sandoz' Hydergine (ergoloid mesylates) was 311% of labeled potency. FDA issued a "Talk Paper" May 12 advising that "consumers should avoid any drug supply source that offers to sell them prescription drugs without a prescription" and that any person purchasing drugs from the 11 listed companies "should consult their physicians." The agency said it "had to go public" with the findings due to the threat to consumer health. Other Operation Rx participants include the U.S. Customs Service, Internal Revenue Service, California Department of Justice, California Bureau of Narcotics and Enforcement, Florida Office of the State Prosecutor, Florida Department of Law Enforcement and Florida Department of Health and Rehabilitative Services. FDA has been active in cracking down on alleged drug fraud recently. In March 1992, the San Diego U.S. Attorney's Office seized more than 15 tons of illegally imported "new-age" drug products from the "fountain of youth" drug import ring ("The Pink Sheet" March 23, 1992, T&G-13). Four months later, the Federal Bureau of Investigation arrested pharmacists nationwide as part of "Operation Goldpill" ("The Pink Sheet" July 6, 1992, p. 3).
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