FDA lets drugmakers advise doctors on unapproved or off label use
Posted Jan 14 2009 6:33pm
The rules also apply to medical devices, however, Dr. Wolfe, newly appointed to the FDA wants it reversed. There has always been controversy around off label use of drugs, especially when anyone goes to court. BD
WASHINGTON (Reuters) - U.S. health officials finalized guidelines that make it easier for pharmaceutical companies to tell doctors about unapproved uses of medicines, a practice opposed by critics of industry marketing.
The Food and Drug Administration (FDA) guidelines explain when manufacturers such as Pfizer Inc and Merck & Co may distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.
The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.
Off-label use "means there isn't adequate evidence that the benefits outweigh the risks to have it approved by the FDA," said consumer advocate Sidney Wolfe, director of Public Citizen's Health Research Group. He called for the guidelines to be reversed once Democrat Barack Obama becomes president.