Ruling flips off-label drug rule on its head
Federal Food and Drug Administration (FDA) regulations have historically prohibited unsolicited communications from drug companies to physicians about off-label use of approved prescription drugs. These restrictions were relaxed somewhat by legislation scheduled to take effect this fall.
However, the situation has been clouded by a recent U.S. district court ruling concluding that FDA off-label informational regulations are excessive and tread on drug makers' constitutional right to free speech. The ruling also says the FDA cannot legally stop drug manufacturers from distributing materials to physician offices about drugs or devices that appeared in peer-reviewed scientific journals or textbooks.
"The decision could have very broad implications because it is grounded in First Amendment principles," said Paul D. Rubin, a food and drug attorney at Patton, Boggs & Blow, a Washington, DC, law firm.
Specifically, the court threw out the FDA's presumption that any type of off-label information - even that derived from independent scientific findings and published in peer-reviewed scientific journals or textbooks - is false and misleading until approved by the agency.
In its place, the court favored other mechanisms, such as the requirement that all off-label information be accompanied by a disclaimer to provide adequate incentive for companies to do additional scientific studies. Firms still are not allowed to distribute purely promotional material and cannot advertise off-label indications directly to consumers.
The impact of this action on local practices is simple: "We don't want physicians inundated with junk" as a result, says Karla Kindermann, a lawyer for the Chicago-based American Medical Association.
Under the 1997 FDA Modernization Act, drug makers are allowed to distribute unsolicited off-label information to physicians if they meet a series of stringent requirements and clinical studies necessary to obtain the FDA's blessing.
The big question now is what impact the court's ruling could have on the FDA's implementation of these new clearance procedures.
The AMA is considering backing additional restrictions on the type of journals and textbooks necessary to fall within the court's guidelines.
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