FDA loosens restrictions on announcements of not-yet-approved drug uses

ROCKVILLE, Md. The Food and Drug Administration has issued guidelines to loosen restrictions on when drug makers can inform physicians about unapproved uses of drugs.

Critics of the drug industry oppose the policy, which the Bush Administration will put in place as it prepares to leave office, saying it could pose a danger to patients. Doctors are allowed to prescribe drugs for uses that the FDA has not approved, but drug companies cannot promote them as such.

In March, Otsuka Pharmaceuticals agreed to pay $4 million to settle allegations that it promoted the use of the schizophrenia drug Abilify (aripiprazole) in children with Bristol-Myers Squibb without FDA approval.