New FDA guidance on off-label promotion falls short for everyone: obama administration is likely to revisit it.

cept for this important fact: the exemption required companies to submit promotional material to the FDA before distributing it and to apply to the FDA for a supplemental New Drug Application (NDA) for the unapproved use. These two requirements have been eliminated in the new guidance—an omission that has greatly disturbed P&T committees and public inter est groups; these groups see the stripped-down guidance as a way for drug companies to sell drugs for un approved uses without having to go to the expense of submitting an application for approval and thus undergoing the reviews incumbent in that process. Drug companies take a different view. Genentech, for example, cites its medication rituximab (Rituxan), which the FDA approved in 1997 for CD20-positive, B-cell non-Hodgkin’s lymphoma. At the end of 2000, important data on an offlabel use of rituximab in diffuse, large B-cell lymphoma (DLBCL) was published in the journal Blood. Even though the National Cancer Institute cited rituximab as a treatment option in February 2002 and as the standard of care for DLBCL in August 2002, it took Genentech until 2006 to receive the FDA’s approval for that use. It is this kind of scenario that explains why pharmaceutical manufacturers, especially those of fering cancer treatments, pushed hard for the widest berth in the FDA reprint policy. Yet the Bush FDA, which was considered sympathetic to the pharmaceutical industry, stopped well short of giving the industry all it wanted. For example, there is no “safe harbor” in the guidance of January 13, 2009. Genentech, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Medical Information Working Group, which is composed of numerous brand-name companies, also wanted the FDA to remove the language in the February 2008 draft guidance. The The FDA, under President George W. Bush, issued last-minute guidelines that make it easier for pharmaceutical companies to promote “offlabel” uses of approved drugs. However, the guidance ignored the entreaties of drug companies to loosen the rules further, and—just to show its even-handedness—rejected requests from P&T committees and public interest groups to tighten those rules. This means that the FDA under President Obama might make some changes outlining what kind of medical journal articles pharmaceutical marketers can distribute to physicians in an effort to convince them to prescribe a drug for an unapproved use. Off-label promotion is now illegal, but it was allowed by the FDA Modernization Act (FDAMA) of 1996 when companies met certain conditions. That law expired in September 2006. While the law was in force, the FDA never challenged a drug company solely for distributing questionable reprints, according to Richard Samp, Chief Counsel for the Washington Legal Foundation. Claiming that its reprint policies violated the First Amendment rights of drug companies, Mr. Samp sued the FDA. The FDA has levied large fines against drug companies for promoting medications for off-label uses but not for distributing reprints; this is an important distinction. The Obama administration may want to toughen up the new guidance and, perhaps even more importantly, reverse the Bush FDA’s refusal to investigate potential violations and, if necessary, pursue penalities. Certainly, some Democratic constituencies will be pushing the FDA in that direction. After the guidance was issued, Representative Henr y Waxman (D-Calif.), Chairman of the House Energy and Commerce Committee, which oversees the FDA, said, “I hope this policy will be carefully re-examined by the new administration.” Judy Cahill, Executive Director of the Academy of Managed Care Pharmacy (AMCP), feels the same way. She says: