Laws Will Require Physician Approval For Generic Prescription Drug Substitutions

Armen Hareyan's picture

A number of Epilepsy Foundation state affiliates nationwide havecampaigned for state legislatures to pass legislation under whichpharmacists would have to obtain physician approval before they couldswitch prescriptions for brand-name epilepsy medications to generictreatments -- a "sign of how the industry, long a potent lobbying forcein Washington, is increasingly looking to states to achieve its goals,"the Wall Street Journal reports. Four major brand-nameepilepsy medications will lose patent protection from 2008 to 2010. In2006, the four medications, which also have other uses, had combinedU.S. sales of $5 billion.

In most states, pharmacists canswitch prescriptions for brand-name medications to generic treatmentsclassified 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 evidencethat patients experienced seizures and other side effects after theyswitched from brand-name epilepsy medications to generic treatments.

In1999, the foundation raised the issue with FDA, but the agency declinedto take action without scientific evidence that patients who switchfrom brand-name epilepsy medications to generic treatments haveincreased risk for seizures and other side effects. Sandy Finucane, whooversees state and federal policy for the foundation, said that thefoundation would have had to conduct a major clinical trial to obtainsuch evidence. Finucane said that the foundation likely would have hadproblems with enrollment of participants in such a trial and could notafford to conduct the trial.

Issue Returns

According to the Journal,the issue "re-emerged" in 2006 when the Illinois Legislature considereda bill under which pharmacists would have to obtain physician approvalbefore they could switch prescriptions for brand-name epilepsymedications to generic treatments.


The foundation in May 2006convened a committee of medical experts to examine the issue. Accordingto the committee, no scientific evidence existed to prove that patientswho switch from brand-name epilepsy medications to generic treatmentshave increased risk for seizures and other side effects, committeechair Steven Schachter, a Harvard Medical Schoolneurologist, said. However, the committee recommended that physiciansapprove switches from brand-name epilepsy medications to generictreatments because of the anecdotal evidence of increased risk.

InSeptember 2006, the foundation announced plans to provide modellegislation in the event that affiliates sought to lobby statelegislatures to pass legislation under which pharmacists would have toobtain physician approval before they could switch prescriptions forbrand-name epilepsy medications to generic treatments.


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

Sindi Rosales --director of a foundation affiliate in Texas, one of the states thatconsidered the model legislation this year -- said, "These are people'slives that we're talking about -- nothing about stock options and stockvalue and how this would affect (companies') bottom line. That would beinsulting to us to have discussions like that." Rosales said thatpharmaceutical companies have served as "fabulous partners" in effortsto 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 thatthe "action is in the states" because legislation can move "from idea,to passage, to governor's signature in 90 days, sometimes faster thanthat."

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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