Magazine article Drug Topics

Generic Substitution Advances on the State Level

Magazine article Drug Topics

Generic Substitution Advances on the State Level

Article excerpt

There is a silent but furious war being waged in the state legislatures of America between patients who go hungry in order to pay for medication and brand-name drug companies seeking to protect their market share. Recently, however, a battle has been won in Florida, where state law regarding the "negative formulary" was recently overturned.

After three long years of wrangling, four drugs were newly allowed generic substitution. First among them was the blood thinner Coumadin (warfarin sodium). Coumadin, produced by DuPont, brings in $535 million a year, or $1.4 million a day.

Up to now, DuPont has had the market to itself by lobbying to keep the drug out of the reach of generic competition. By placing drugs that have Food & Drug Administration-approved generic versions on a so-called negative formulary-a list of branded drugs for which generic substitution is not permitted-states enable brand-name monopoly and prevent public access to the cheaper versions. Only two states restrict generic substitution of warfarin for Coumadin by means of a negative formulary, and Florida has been one of them.

Coumadin is the 11th most often prescribed medication in the United States-and 80% of patients for whom it is prescribed are over the age of 60. Thus, this new ruling is a major break for these elderly patients, who are having to pay 300% more for the same bottle of Coumadin than they did 10 years ago. Barr Laboratories is offering to manufacture the generic version at a 40% cost saving to the consumer, yielding benefits to both patient and state.

Florida's department of health expects to save $104,000 annually as a result of these changes, and experts estimate that Medicaid could save about $4 million from buying these less expensive generics. Individual patients would save $150 a year-$40 million statewide-by switching to generic warfarin.

Other drugs removed from the restricted list in Florida include phenytoin (Dilantin) for seizure control, theophylline (Slo-bid Gyrocaps) for bronchitis and asthma, and quinidine gluconate (Quinaglute Dura-tabs) for controlling irregular heartbeat. According to John Taylor, executive director at the Florida Board of Pharmacy, letters announcing negative formulary repeals will be sent out to community pharmacies by the end of the summer.

While brand-name companies claim safety reasons and a desire to protect patient health in their fight against generics, often they are simply trying to preserve their own turf. …

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