Managed Care - March 2008 - (Page 26) generic competition between next year and 2010. the same legislation that the Epilepsy Foundation The four drugs generated $5 billion in U.S. sales in wants now. 2006, according to IMS Health, meaning the state DuPont’s campaign worked: A number of states legislation could have a significant economic effect. did pass laws requiring health system pharmacists (Some of the $5 billion is for sales of the drugs for to check with physicians. other uses.) The FDA wrote to doctors and said that the Carve-outs “undermine the patient’s access to generic warfarin was equivalent. The agency said it generic medications, increase costs and increase a viewed the efforts by DuPont as undermining the pharmacist’s workload,” says Mark Merritt, PCMA generics approval process by calling into question president. He views the proposed legislation as “one the underlying science. “There are no documented more attempt by brand manufacturers to force examples of a generic product manufactured to pharmacists to do their work for them by promotmeet its approved specifications that could not be ing the use of brand drugs. If physicians want to used interchangeably with the corresponding mark an epilepsy script DAW, they can and will.” brand-name drug,” an FDA associate commisGenerics proponents say that every time blocksioner, Stuart Nightingale, MD, wrote to 200 medbuster drug patents are about to expire, the pharical groups in 1998. maceutical companies — often through the foun“Additional clinical tests or examinations by the dations and professional organizations they health care provider are not needed when a generic support — try to make generic substitution for drug product is substituted for the brand-name those drugs more difficult. product.” This is, in fact, a reoccurring story. In the late The agency issued a public statement warning 1990s, the Epilepsy Foundation raised concerns DuPont, “We cannot overstate the seriousness with about anecdotal reports that some patients experiwhich we regard DuPont’s false and misleading enced seizures and side effects after switching promotion of Coumadin.” epilepsy drugs. Some of the episodes involved patients who had been switched to a generic Who funds the Epilepsy Foundation? from a branded drug. The foundation also ritics of the Epilepsy Foundation’s call for requiring expressed concern about cases in which paphysician advance authorization of any generic substitutients were switched from one generic vertion of antiepilepsy drugs say the organization is largely sion of a drug to another generic version of funded by brand-name pharmaceutical companies. Foundathe same drug. tion officials say its diverse funding shields it from undue Similar concerns were being expressed drug-company influence. The foundation does receive fundabout other drugs. In 1998, DuPont had ing from pharmaceutical companies, including public grants waged a campaign to convince state legislatotaling about $50 million of its approximately $80 million tures and state agencies to limit the ability of annual budget. According to the foundation, here are some pharmacists to switch patients to warfarin. of its pharmaceutical supporters in 2006: The company said that its anticoagulant $500,000–$900,000 Coumadin is a “narrow therapeutic index” Eisai drug, meaning that there is a narrow range GlaxoSmithKline of safe blood levels of the drug. Too little of UCB the drug leads to strokes, and too much leads $100,000–$499,999 to internal bleeding. The implication was Abbott Laboratories that the generic had a different therapeutic Novartis Pharmaceuticals index. Ortho-McNeil Neurologics There was a lot of money at stake. Back (subsidiary of Johnson & Johnson) Pfizer then, Coumadin was generating about $500 $25,000–$49,999 million in yearly sales for DuPont. The comPharmaceutical Research and Manufacturers of America pany pursued legislation in dozens of states to prohibit drug switching unless a druggist Sources: EF Annual Report 2007 first got a doctor’s approval — essentially C 26 MANAGED CARE / MARCH 2008
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