New guidelines by U.S. health officials allowing pharmaceutical companies to distribute medical journal articles for the purpose of promoting unapproved uses of medicines, has been finalized.
Criticized by lawmakers as being too lax, the guidelines allow companies such as Merck & Co. and GlaxoSmithKline to tell doctors about unapproved uses of medicines– even when it involves off-label uses that have not been approved by the U.S. Food and Drug Administration (FDA).
Off-label use refers to the practice of prescribing drugs for a purpose outside the range of a drug’s approved label. Once the drug is approved, the FDA does not regulate usage and the doctor is able to make a decision based on his or her best judgment.
Manufacturers are barred from marketing their drugs for uses that have not been approved by the FDA.
Nearly one-fifth of all drugs are prescribed for off-label use. Risperdal, a well known antipsychotic, is one such example. The drug is increasingly being prescribed to children for off label use in attention deficit hyperactivity disorder (ADHD) for which it is not approved. And there are several more instances of well known drugs that are prescribed for off-label use.
Congressional Democrats and drug industry critics objected when the policy was first proposed last year.
Opponents argue the distribution of journal articles promotes untested uses of drugs and will fundamentally undermine requirements that mandate companies to prove each new use is safe and effective.
In September 2006, the law expired and drugmakers have been fighting to have it renewed ever since.
Some drug industry critics are concerned about the reliability of such articles. In April, Merck & Co. came under fire when the company was accused of ghostwriting articles about Vioxx (rofecoxib), its painkiller which was withdrawn in 2004 due to safety reasons.
Reports claimed the company helped create the study on Vioxx and then paid academics or leaders in the medical field to lend their name as the lead author. The company denied the allegations, referring to them as false and misleading.
The new guidelines discourage ghostwriting and specifically recommends companies disclosing any financial ties or affiliations with article authors, the FDA said.
Overall, the agency favors distribution of articles that include unapproved uses of drugs and medical devices.
The new guidelines will help medical professionals to receive accurate and timely medical information while avoiding the tedious process of securing FDA approval for expanded use, said a spokesman for the Pharmaceutical Research and Manufacturers of America. #