You’d think that with Congress shining a spotlight on the financial ties between doctors and drug companies, the FDA might sense the prevailing winds and move toward restricting the marketing of drugs to doctors for unapproved uses. But no, the nation’s premier public health agency appears to be moving in the opposite direction. FDA officials recently announced proposed guidelines that would make it easier for drug companies to promote off-label uses to doctors without studying whether the drugs are effective or safe for such uses. Such a move would mean more off-label prescriptions of drugs that can cause dangerous side effects. Remember Paxil, Zoloft, Vioxx and Avandia? All of these drugs were approved for one condition and then widely prescribed off-label for other conditions. Such widespread usage ended up harming people, many of whom shouldn’t have been taking the drug in the first place.
Take Vioxx, as just one example. The heart problems associated with the drug became apparent only after it was widely prescribed off-label to patients who were unlikely to benefit from it. Similarly, the widespread prescribing of Paxil and other SSRI antidepressants for off-label uses spurred an increase in suicidal thoughts and behaviors among children and young adults taking these drugs. (With both these cases, there is evidence that the makers of the drugs knew about these potentially dangerous side effects but with-held the information from doctors and the general public for many years. www.sideeffectsthebook.com.) One would think the FDA would want to restrict such off-label usage, not promote a policy that would effectually expand it.
It is, of course, illegal for the pharmaceutical industry to market drugs for off-label uses to physicians and consumers. For the past decade, however, drug makers have been allowed to give physicians studies touting off-label uses that they themselves funded and got published in medical journals. But the drug companies could only hand out these studies to doctors if they gave the reprints to the FDA beforehand and promised to seek approval of the uses discussed in them. However, the law that instituted that requirement (the FDA Modernization Act) lapsed in 2006. In the latest proposed guidelines, the FDA has now abandoned the requirement that drug and device makers provide off-label studies to the agency beforehand or promise to seek approval of the discussed uses. In a recent article in the New England Journal of Medicine, Dr. Randall Stafford, an associate professor of medicine at Stanford Prevention Research Center, criticized the agency’s “backward shift,” noting that it “seems oddly incongruous with current pressures aimed at improving post-marketing drug evaluation.” http://content.nejm.org/cgi/content/full/358/14/1427?query=TOC
Stafford called on the FDA to do more to regulate off-label use, not less. The FDA is accepting comments on these draft guidelines through April 21. Let your voice be heard!