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Off-label disclosure on drugs proposed

Feb 25, 2006 | San Francisco Chronicle

Doctors who prescribe medicine for a use not approved by the Food and Drug Administration would have to inform patients of the drug's off-label status under a bill proposed Friday by state Assemblywoman Loni Hancock, D-Berkeley.

Hancock said the death of a constituent's daughter spurred her to draft the legislation, which would create a list of specific disclosures doctors must make to obtain patients' informed consent to treatments never evaluated by the
FDA.

"We make the assumption that drugs that are prescribed or given in the hospital are certified for that use by the FDA,'' Hancock said. "If that's not the case, people have the right to know.''

Many medicines that enter the market after being approved for one disease are later legally prescribed for other illnesses. Doctors may use an off-label drug because no approved medicine exists for an ailment or because some research has raised the possibility that an unapproved treatment is as good or better than an FDA-sanctioned remedy.

While such prescribing is widespread, off-label drugs at times have been linked to serious side effects and deaths. Hancock said she knows of no state, including California, that orders doctors to tell patients when they are receiving an unapproved treatment.

Her bill would obligate doctors and surgeons to inform patients when the FDA has never evaluated the recommended treatment and that "a division of opinion exists as to the efficacy of the use of the medication.'' It would also require doctors to disclose what is known about the side effects of the off-label drug, to outline other possible remedies and to give their reasons for recommending the unapproved treatment instead.

Hancock constituent Maddy Oden of Oakland said she is thrilled by the proposed bill. Oden began a campaign for wider disclosure requirements after her 32-year-old daughter, Tatia Oden French, died during childbirth in 2001. Her labor had been induced by the drug Cytotec an ulcer treatment not approved for that use. Oden said doctors may feel that Hancock's legislation challenges their judgment. But patients, not doctors, live with the consequences of treatment, she said.

"It is their own health that they're making a decision about,'' Oden said.

A spokeswoman for the California Medical Association, Karen Nikos, said the organization will reserve comment on the bill until it has had time to evaluate its language.

The drug industry's main trade association, Pharmaceutical Research and Manufacturers of America, also declined comment. The FDA does not regulate doctors, a role left to the states. But the FDA restricts the promotion of off-label uses by drug manufacturers.