The draft guidance "would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs," Waxman wrote.
Companies would be less likely to conduct definitive scientific studies and seek formal FDA approval for alternative uses of drugs and devices if they could promote and profit from off-label uses anyway, Waxman contended. He said the proposal could grant undue influence to incomplete or distorted studies, some of them industry-funded. And he pointed to several high-profile cases in which drugs such as Vioxx and Celebrex were trumpeted in flawed journal articles that either underreported dangers or overstated benefits.
"While there may need to be a balance between First Amendment and protection of the public health," Waxman wrote, "the answer is not to open the door to unrestricted dissemination of potentially questionable information about drug safety and effectiveness."
FDA Considers Easing Curbs on Drug Makers
Research on Off-Label Use Could Be Sent to Doctors
By Christopher Lee
Washington Post Staff Writer
Saturday, December 1, 2007; A04
The Food and Drug Administration is considering allowing pharmaceutical makers to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for "off-label" purposes.
Under a draft "guidance" prepared by the FDA, drug and medical device manufacturers could distribute unabridged reprints of peer-reviewed research from reputable medical journals as long as the articles were not written, edited or otherwise "significantly influenced" by the manufacturers or people with financial ties to them. No other promotional materials could be attached to the reprints, which would have to be labeled as describing uses for the products that have not been approved by the FDA.
