Institute Condemns FDA Crackdown on Truthful Drug Advertising

Institute Condemns FDA Crackdown on Truthful Drug Advertising

Off-Label Drug Prescribing Is Crucial to Proper Care
September 04, 2009

The Competitive Enterprise Institute today condemned a recent Food and Drug Administration and Department of Justice crackdown on the dissemination by drug manufacturers of information regarding “off-label” uses of prescription drugs.  This week, pharmaceutical maker Pfizer announced it had paid $2.3 billion to settle civil and criminal charges stemming from the off-label promotion of four drugs. Earlier this year, Eli Lilly and Co. settled a similar case for $1.4 billion.

Washington, D.C., September 4, 2009—The Competitive Enterprise Institute today condemned a recent Food and Drug Administration and Department of Justice crackdown on the dissemination by drug manufacturers of information regarding “off-label” uses of prescription drugs.  This week, pharmaceutical maker Pfizer announced it had paid $2.3 billion to settle civil and criminal charges stemming from the off-label promotion of four drugs. Earlier this year, Eli Lilly and Co. settled a similar case for $1.4 billion.

“Off label prescribing is not only common in every field of medicine, but is frequently considered to be the recognized standard of care,” said Gregory Conko, a CEI senior fellow. “Physicians can even be subject to malpractice liability if they don’t use treatments for off-label indications when doing so constitutes the medically recognized standard of care. So, it makes no sense for FDA to criminalize off-label promotion in all cases.”

When the FDA approves new drugs or medical devices, they are approved to treat specific conditions in particular populations, which are identified on the products’ labels.  But, once they are on the market, doctors are free to prescribe drugs and devices for any safe and effective use, including ones not indicated on the label.

“By some estimates, as many as 60 percent of all prescriptions written are for off-label uses,” said Conko.  “This crackdown on truthful information will make it more difficult for doctors and their patients to find out about potentially beneficial treatment options.”

The FDA has long forbidden nearly all drug manufacturer promotion of off-label uses for their drugs, even though federal courts have repeatedly held that such a broad restriction is unconstitutional. Only the limited distribution to physicians of peer reviewed scientific studies on off-label uses is permitted. But, in recent months, even these efforts have come under attack by critics of off-label prescribing.  Rep. Henry Waxman (D-CA), chairman of the House Energy and Commerce Committee, which oversees the FDA, has called the distribution of scientific studies “abusive marketing practices” that promote “potentially dangerous uses” of drugs.

“The FDA and other critics of off-label drug promotion exaggerate the credulity of physicians and their willingness to unquestioningly trust information distributed by drug manufacturers,” said Conko.  “More importantly, they ignore the significant benefits that off-label prescribing offers for patient care.”

CEI is a non-profit, non-partisan public interest group that studies the intersection of regulation, risk, and markets.