Just days before the Bush administration turns over power to President-elect Barack Obama’s government, the Food and Drug Administration reveals new guidelines that allow pharmaceutical companies to tell doctors about unapproved uses of their drugs. The measure was highly criticized as it represents a step backward in enforcement standards for the pharmaceutical industry.

 

Rep. Henry Waxman, D-Calif., the incoming chairman of the House Energy and Commerce Committee, expressed his disapproval towards the guidelines by saying, “in the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift. This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective.” He also added that he hopes that the new administration will re-examine the issue and come with an appropriate solution in order to keep Americans away from possible side effects of drugs used without approval.

 

Consumer advocate Sidney Wolfe, director of Public Citizen's Health Research Group, also backed the idea saying “off-label use ‘means there isn’t adequate evidence that the benefits outweigh the risks to have it approved by the FDA.’” Therefore, he hopes that the new guidelines will be reversed once Democrat Barack Obama becomes president.

 

Under the US’ law, drug makers are not allowed to market their drugs for uses not approved by the FDA, but doctors can prescribe drugs for any use they think fit. The practice is known as “off-label” use.

 

Under the new guidelines, drug makers are allowed to distribute copies of medical journal articles that describe unapproved uses. In other words, the new guidelines encourage manufacturers to stop doing more tests on drugs’ unapproved uses. Therefore, the manufacturers won’t have to present their findings to the FDA for possible approval, a measure seen by some representants of the industry as a way to help companies to expand the markets for medicines and medical devices.

 

However, opponents of the guidelines fear that such journal articles might not be reliable. Not long ago, for example, drugmaker Merck & Co. was accused of ghostwriting several articles about painkiller Vioxx, which was withdrawn from the market in 2004 for safety reason. The FDA says though that the new guidelines discourage ghostwriting and specifically recommends companies disclosing any financial ties or affiliations with article authors.

 

According to statistics, nearly one-fifth of all drugs are prescribed for off-label use. One simple example is Risperdal, a well-known antipsychotic, which is highly being prescribed to children for off-label use in attention deficit hyperactivity disorder. The drug is not approved for this use by the FDA.

 

The new guidelines were posted on the FDA Web site on Monday.