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    Congress urges FDA crackdown on epidemic of counterfeit drugs

    Possible steps include licensing distributors and drug 'pedigree' plan


    Bob Gatty
    Washington—Counterfeit prescription drugs pose a "potentially serious health threat" in the United States, one that can result in serious or deadly consequences for patients because of unscrupulous acts of profiteers who take advantage of a lack of uniform regulation and enforcement.

    That was a key message presented at a Nov. 1 hearing before the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources, during which officials of the FDA, the pharmaceutical industry, interest groups, and members of the public whose lives have been affected by counterfeit drugs discussed their concerns and recommendations.

    "According to the World Health Organization, 10% of global pharmaceutical commerce this year will be counterfeit," said Subcommittee Chairman Mark Souder (R-IN). "That number is expected to double by the year 2010. Last year, within the United States, the FDA's counterfeit drug investigations rose 150% in only 12 months."

    Randall W. Lutter, PhD, acting associate commissioner at the FDA, outlined recent investigations by the agency's Office of Criminal Investigations (OCI), which initiated 58 counterfeit drug cases in 2004, up from just 30 in 2003.

    "FDA is concerned that the drug supply is under unprecedented attack from a variety of increasingly sophisticated threats," he said. "This disturbing trend is evident in the increased efforts to introduce counterfeit drugs into the U.S. market."

    Among popular drugs subject to counterfeiting are such erectile dysfunction medications as sildenafil citrate (Viagra) and tadalafil (Cialis), Dr. Lutter said, noting that on Sept. 12, 2005, the U.S. Attorney's Office for the Southern District of Texas announced the indictment and arrest of an individual for his alleged involvement in the importation from China and subsequent distribution of counterfeit drugs, including these two medications.

    Fast Facts
    As a result of the investigation, Chinese authorities arrested 11 suspects who will be prosecuted by the Chinese government for their involvement in manufacturing and distributing counterfeit Viagra, Cialis, and atorvastatin calcium (Lipitor). Chinese officials recovered 600,000 counterfeit Viagra labels and packaging, 440,000 counterfeit Viagra and Cialis tablets, and 260 kg of raw materials used to manufacture counterfeit drugs.

    In the summer of 2004 and again in the spring of 2005, OCI received "voluntary suspect counterfeit drug" notifications from the manufacturers of simvastatin (Zocor), carisoprodol (Soma), raloxifene hydrochloride (Evista), Lipitor, and Viagra. Counterfeit versions of these drugs were being sold to U.S. consumers from Mexican pharmacies along the U.S. border. Analysis of these drugs showed they either contained little or no active ingredients.

    In another case involving Viagra, a California man pled guilty in January 2005 to importing counterfeit Viagra from China and manufacturing 700,000 counterfeit tablets. Total value of the counterfeit Viagra was more than $5.65 million.

    Souder pointed out that a key problem is the "gray market," which results from drug diversion, the principal method by which counterfeits enter the legitimate drug market. This can occur when employees at pharmacies at nursing homes or hospitals, which acquire medication at prices much lower than wholesale, resell them at a higher price into the gray market, he explained.

    "This happens easily because the pharmaceutical supply chain is not regulated by any single entity, private or governmental," Souder said. "The pharmacies within a state are monitored by the state boards of pharmacy, which enforce the standards of care within each state. However, the state boards of pharmacy lack police power, and many are limited to only a handful of inspectors."

    Souder pointed out that manufacturers must comply with FDA requirements for safety, effectiveness, and labeling, but they have no control over their products once they are shipped. The drugs are bought and sold by distributors, Souder said, and frequently pass in and out of the secondary market.


    Bob Gatty
    Bob Gatty, a former congressional aide, covers news from Washington for Urology Times.


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