House lawmakers are pushing for the Obama administration to allow drug companies to advertise unapproved drug uses to doctors, a big priority for the pharmaceutical industry.
Leaders of the House Energy and Commerce Committee want the Department of Health and Human Services to relax its requirements on advertising of “off-label” uses of a drug.
A doctor is able to prescribe a drug for a use that isn’t approved by the FDA. For instance, doctors typically prescribe the cancer drug Avastin to treat an eye disorder. But it is against the law for a drugmaker to advertise such “off-label” uses to doctors.
Reps. Fred Upton, R-Mich., and Joseph Pitts, R-Pa., say that a series of court decisions has called into question “off-label” advertisements. Upton is chairman of the committee and Pitts heads up the health subcommittee.
“Recent litigation has raised significant questions about FDA’s authority to restrict such communication,” they wrote to HHS Secretary Sylvia Burwell.
The lawmakers were referring to a 2012 decision in the 9th Circuit Court of Appeals that said prohibiting the marketing of off-label use violates the First Amendment.
The lawmakers called on the FDA to issue guidance on the proper way to market off-label use and wonder if they have been hampered by HHS.
“It has come to the committee’s attention that such inaction may be the result of disagreements between FDA and HHS leadership,” the letter said.
Loosening restrictions on off-label use has been a priority for the pharmaceutical industry for years, as companies want another way to sell drugs to doctors.
“A regulatory framework that enables manufacturers to share accurate, data-driven information about complex, modern medicines will enhance patient outcomes,” according to a 2015 blog post from Mit Spears, general counsel for the Pharmaceutical Research and Manufacturers of America, the industry’s top lobbying group.
