Epilepsy Foundation Pushes For Laws That Would Require Physician Approval For Generic Prescription Drug Substitutions

Main Category: Epilepsy
Also Included In: Primary Care / General Practice;  Pharmacy / Pharmacist
Article Date: 17 Jul 2007 - 14:00 PDT

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A number of Epilepsy Foundation state affiliates nationwide have campaigned for state legislatures to pass legislation under which pharmacists would have to obtain physician approval before they could switch prescriptions for brand-name epilepsy medications to generic treatments -- a "sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals," the Wall Street Journal reports. Four major brand-name epilepsy medications will lose patent protection from 2008 to 2010. In 2006, the four medications, which also have other uses, had combined U.S. sales of $5 billion.

In most states, pharmacists can switch prescriptions for brand-name medications to generic treatments classified as equivalent by FDA. The foundation -- which receives funds from a number of pharmaceutical companies, such as Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson and UCB -- in the late 1990s began to raise concerns about anecdotal evidence that patients experienced seizures and other side effects after they switched from brand-name epilepsy medications to generic treatments.

In 1999, the foundation raised the issue with FDA, but the agency declined to take action without scientific evidence that patients who switch from brand-name epilepsy medications to generic treatments have increased risk for seizures and other side effects. Sandy Finucane, who oversees state and federal policy for the foundation, said that the foundation would have had to conduct a major clinical trial to obtain such evidence. Finucane said that the foundation likely would have had problems with enrollment of participants in such a trial and could not afford to conduct the trial.

Issue Returns
According to the Journal, the issue "re-emerged" in 2006 when the Illinois Legislature considered a bill under which pharmacists would have to obtain physician approval before they could switch prescriptions for brand-name epilepsy medications to generic treatments.

The foundation in May 2006 convened a committee of medical experts to examine the issue. According to the committee, no scientific evidence existed to prove that patients who switch from brand-name epilepsy medications to generic treatments have increased risk for seizures and other side effects, committee chair Steven Schachter, a Harvard Medical School neurologist, said. However, the committee recommended that physicians approve switches from brand-name epilepsy medications to generic treatments because of the anecdotal evidence of increased risk.

In September 2006, the foundation announced plans to provide model legislation in the event that affiliates sought to lobby state legislatures to pass legislation under which pharmacists would have to obtain physician approval before they could switch prescriptions for brand-name epilepsy medications to generic treatments.

Comments
UCB Vice President Richard Denness said, "Our issue is not selfish toward our individual product. It's a real concern in the minds of prescribers." Denness added, "All it takes in the scheme of things are one or two patients to have a tragic event."

Sindi Rosales -- director of a foundation affiliate in Texas, one of the states that considered the model legislation this year -- said, "These are people's lives that we're talking about -- nothing about stock options and stock value and how this would affect (companies') bottom line. That would be insulting to us to have discussions like that." Rosales said that pharmaceutical companies have served as "fabulous partners" in efforts to lobby the Texas Legislature to pass the model legislation.

Jan Faiks -- who oversees state policy for the Pharmaceutical Research and Manufacturers of America, whose CEO, Billy Tauzin, serves on the foundation board -- said that the "action is in the states" because legislation can move "from idea, to passage, to governor's signature in 90 days, sometimes faster than that."

FDA Office of Generic Drugs Director Gary Buehler said, "The only way you can somehow pin this down is to do a good study" (Rubenstein, Wall Street Journal, 7/13).

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