The Food and Drug Administration considers any company promoting off-label use of any drug it produces to be engaged in a criminal offense. In other words, the manufacturer cannot inform doctors that a particular drug approved to fight one disease may be useful in fighting a different disease for which it is not approved.
Experts say this kind of censorship is costing lives. It also puts doctors in the position of committing malpractice if they fail to prescribe an off-label use of a drug they know to be effective.
o According to the General Accounting Office, 25 percent of anti-cancer drugs are prescribed off-label.
o And 56 percent of cancer patients have been given at least one drug off-label.
o An FDA official says the agency approves of doctors learning about off-label uses from seminars, textbooks, the Internet or colleagues.
o But it does not permit doctors to receive reprints of medical journal articles from pharmaceutical firms -- even if the reprint discloses that the use discussed has not been approved by the FDA.
A year ago, federal Judge Royce Lambeth struck down these FDA restrictions on constitutional free-speech grounds. But the FDA asked the court to declare that it need not adhere to the constitutional principles. Since the judge has yet to rule on the agency's request, the FDA continues to enforce its gag rule on manufacturers.
A case in point is spironolactone, a drug approved decades ago to treat water retention. Just recently it has been found to reduce congestive heart failure. So dramatic are the results that the New England Journal of Medicine just this week rushed into print a study reporting reduced death rates of 30 percent over two years.
But under the FDA rules, doctors won't be receiving reprints of the article from the drug's manufacturer any time soon.
Source: Daniel E. Troy (American Enterprise Institute), "FDA Censorship
Could Cost Lives," Wall Street Journal, July 23, 1999.