Accredited CME programs are no longer the only legally sanctioned forum for education about off-label uses of drugs and medical devices. In a July 30 decision, U.S. District Judge Royce C. Lamberth ruled that FDA regulations that prohibit drug and device companies from disseminating information about off-label uses are a violation of the manufacturers' commercial speech rights. The Washington Legal Foundation, a nonprofit public interest law and policy center that objects to government regulations, initiated the lawsuit in 1994.
Specifically, Lamberth stated that the FDA cannot restrict drug and device manufacturers from distributing articles or books about off-label uses, as long as the articles were previously published in "bona fide" journals and textbooks. Focusing on CME seminars, the decision also stated that the FDA cannot prohibit companies from suggesting content or speakers to "independent CME providers." The ruling defined independent providers as those accredited organizations that have no affiliation with pharmaceutical or device companies.
The FDA is not rendered totally toothless by the decision--Lamberth stated that the agency still has the right to prohibit distribution of material that is false or misleading. Disclosure also remains within FDA purview. When a company financially supports a seminar about off-label uses, the FDA may require the company to disclose its own interest in the drugs or devices under discussion, and also to disclose that the uses are not FDA-approved.
Despite the ruling, companies will still put their money behind CME, says Frederic S. Wilson, manager of CME, The Procter & Gamble Company, and chair of the Pharmaceutical Alliance for CME. "I see little impact on CME," he says. "CME is an effective way to 'credentialize' scientific information." Today's busy physicians are more likely to take the time to attend an accredited program, Wilson points out, than review promotional materials. "They want that Good Housekeeping seal," he says.
For CME providers, the regulations remain the same. "We don't intend to change our regulation and standard-setting of CME," says Murray Kopelow, MD, executive director, Accreditation Council for CME. The FDA can appeal the ruling, but according to the Wall Street Journal, has not yet decided what action it will take.
To view the full text of Lamberth's decision, go to http://www.fdcreports.com/RULING.HTM.
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