Off Label Promotion — A Bad Idea Whose Time Has Come!

Although physicians and other clinicians with prescribing authority have always been able to prescribe drugs for any condition which they think may be helped by that specific drug, pharmaceutical companies have been prohibited from promoting drugs for unapproved uses. Only uses which have been approved by the FDA are listed on the label and unapproved uses are commonly called "off label". Even though the ability to advertise their drugs for additional uses should be enough of an incentive for drug companies to seek additional approval, many companies don't. Instead, they have often looked for creative ways to promote the use of drugs without advertising. By the early 1990s, a miniindustry had developed of conferences and speaking tours funded and controlled by drug companies at which speakers extolled the benefits of drugs for uses which hadn't yet been approved. Under the leadership of Commissioner Kessler, the FDA tried to crack down on this "gray market" advertising, by requiring drug companies to give up control of the content of conferences and speaking tours which they supported. Naturally, most drug companies and some doctors, especially those who had benefitted from handsome speaker's fees, were quite upset at the new restrictions.

When Newt Gingrich was elected Speaker of the House of Representatives, his Contract with America promised government deregulation. Drug companies saw an opportunity to reverse the new restrictions and possibly even some of the old ones. After three years the drug companies have succeeded. The FDA "reform" legislation signed into law by President Clinton last fall (The FDA Modernization Act of 1997) allows companies to promote their drugs for uses which have not yet been approved by the FDA. Supporters of the law claim that the public won't really be at risk of irresponsible or untruthful advertising, because the law requires drug companies to submit an application within three years of beginning to promote the new use. The Network strongly opposes off label promotion and believes that Congress and President Clinton are virtually guaranteeing that certain drugs will be advertised and later found to be ineffective. In the meantime, consumers may well suffer side effects and complications from these drugs. In the words of one FDA Medical Officer, "No side effect is worth it if the drug is ineffective." Too bad Congress doesn't agree.