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FDA Proposed Off-Label Marketing Rule Changes Will Hurt Consumers, Critics Say

Feb 18, 2008 | Parker Waichman LLP

Off-label marketing of drugs and medical devices, currently prohibited by the Food & Drug Administration (FDA), could soon be allowed under some circumstances.  The FDA has proposed allowing drug and Medical device makers to provide doctors with copies of medical journal articles that discuss off-label uses of their products.  The proposed rule changes have many consumer advocates and some in Congress crying foul, arguing that such a policy could expose patients to a risk of serious, and possibly fatal injuries.

Off-label use is the use of a drug or medical device for a purpose not approved by the FDA.  For example, gadolinium contrast dyes are often used off-label in MRA (Magnetic Resonance Angiography) procedures, even though such agents are only approved for use in MRI procedures.  Once a drug or medical device has been approved by the FDA, doctors are free to prescribe it as they see fit.  In fact, a 2006 study estimated that more than 20 percent of all prescriptions written by doctors were for unapproved uses. However, drug and medical device companies are prohibited from advertising off-label uses.  In 1997, Congress created a temporary exception to the off-label marketing rule by allowing drug makers and medical device companies to distribute reprints of peer-reviewed research from reputable medical journals that discussed off-label uses to physicians.  Drug makers and medical device manufacturers were able to do so long as they submitted the articles to the FDA for advance review and had formally asked the FDA to approve the new use described in the journal article.  That exception expired in 2006.

The FDA wants to renew the exception, with some very big changes.  Under the proposed rule, the agency would let drug and device companies pass out articles to doctors if the articles were peer-reviewed and came from a journal with an expert editorial board. The article must be accompanied by a prominent warning that the use described is not approved or cleared by the FDA.  However, the FDA wants to drop the requirement that drug and device makers must provide the studies to the FDA beforehand or promise to seek approval of the discussed use.   According to The New York Times, the FDA has justified this proposed loosening of the rules by claiming it never really enforced those requirements anyway.

The FDA’s new proposed off-label marketing rules have raised the ire of many law makers and consumer advocates.  They point out that drug and medical device makers have long flouted the rules governing off-label marketing, often to the detriment of consumers.  According to The Wall Street Journal, the Justice Department has recently gone after numerous drug companies accused of off-label marketing.  For instance, Pfizer Inc. settled a case about the epilepsy drug Neurontin in 2004 for $430 million. In another high-profile case, Eli Lilly is said to be in negotiations with the Justice Department over illegal marketing of Zyprexa.  According to media reports, Eli Lilly could end up paying in excess of $1 billion to settle allegations it marketed Zyprexa for unapproved uses, including dementia, depression and autism.

According to The New York Times, critics of the FDA rule changes argue that allowing companies to talk about such unapproved uses removes incentives for companies to research adequately whether the new use is actually beneficial.“People will die if they are getting drugs that don’t have clear evidence that the benefits outweigh the risks,” Dr. Sidney Wolfe, director of Public Citizen’s health research group, told the New York Times. Representative Henry Waxman, (D – Calif.) told the Times that proposed rule “caters to the industry’s desire to market their products without adequate testing or review.”


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