My colleague John Berlau wrote a nice obituary of mutual fund pioneer Jack Dreyfus that was published in Investor’s Business Daily earlier this week. One thing John points out that few readers are likely to have known about Dreyfus is his long-time advocacy of more liberal FDA regulation of off-label drug promotion.
FDA has the statutory authority to regulate promotional materials distributed by pharmaceutical companies about their products, and the agency imposes a near-total ban on distributing information about unapproved, or so-called off-label, uses. Once FDA approves a drug for any indication, doctors are free to prescribe it for any other use. The practice is so widespread that an estimated 60 percent of all prescriptions are for off-label uses. In some cases, off-label use is considered the standard of medicine, and doctors can be liable for malpractice if they do not prescribe that drug off-label.
Still, FDA likes control. Until recently, it even forbade the distribution of article reprints from peer-reviewed medical journals describing the results of clinical trials on off-lable uses. When the Bush Administration FDA proposed in 2007, and published in 2009, a guidance document permitting limited distribution of peer-reviewed journal articles, FDA critics such as Rep. Henry Waxman pitched a fit. And, according to an article in this week’s New England Journal of Medicine, there is reason to believe that the Obama Administration will revisit the issue and may rescind the guidance document.
According to Berlau, Dreyfus once wrote that, “Apparently full disclosure is required on the negative side, but no disclosure is permitted when the evidence is positive, unless it has an FDA-listed indication of use … No matter how flimsy the evidence for the negative, it must be disclosed. No matter how solid the positive evidence, it may not be mentioned. It seems a poor way to run a railroad.” Indeed.