July 6, 2012 – In the aftermath of the July 2 announcement of a $3 billion settlement between GlaxoSmithKline and the U.S. Department of Justice – in part due to allegations that GSK promoted off-label uses – the Food and Drug Administration needs to take a fresh look at its off-label promotion policy, according to Coalition for Healthcare Communication Executive Director John Kamp.
“Doctors and patients need to know the latest scientific evidence on the effective and safe use of drugs, but the antiquated FDA rules on off-label communication prohibit companies from fully educating them,” Kamp said. “It’s time to put
a stop to these prosecutions. They impede doctor education and patient care and likely violate the First Amendment.”
In the recent settlement, GSK resolves previous criminal and civil liabilities. Under the settlement’s terms, GSK will plead guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act related to the marketing of Paxil for pediatric use and of Wellbutrin for certain uses, as well as a failure to include information about the initiation or status of certain Avandia studies.
“Today brings to resolution difficult, long-standing matters for GSK,” GSK CEO Sir Andrew Witty said in a July 2
statement. “Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”
Kamp added that “policy makers and the public should understand that GSK is fully compliant today with the government’s censorship mandates and has been for many years.”
Current agency policy allows health professionals to prescribe drugs for off-label use, but does not allow manufacturers to communicate with doctors and patients about these off-label uses to consumers. Under these rules, all health professionals and others – except the drug sponsor – are allowed to engage in communications about the off-label use. “The fact that this rule restricts the speech of none but the drug sponsor violates consistent decisions by the Supreme Court, including the recent IMS ruling,” explained Kamp.
Moreover, in its most recent draft guidance on off-label promotion, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” issued Dec. 27, 2011, the agency describes the legal framework for the agency’s restrictions on off-label speech, but stipulates that “these off-label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care.”
In Kamp’s view, the government must move forward to enable drug companies to fully participate in education and communication about new uses of approved drugs. Without this, doctors and patients are not as likely to have full information about the safety and effectiveness of available medical options. However, Kamp acknowledges that changes to current policy may require Congressional action.
“It is in the best interest of patients everywhere that the FDA revisits its off-label policy swiftly,” he noted. If the agency does not, it may be time for the U.S. Supreme Court to settle the matter, he explained. “I’m optimistic that federal appeals courts and the Supreme Court will step in to review the off-label censorship of drug companies under the mandates of the First Amendment,” he said.