Why Legislation is Needed:

The FDA does not regulate doctors. That role is left to individual states.

On February 24, 2006, California Assembly woman Loni Hancock, D-Berkeley, proposed Assembly Bill 2856 that would require doctors to secure a patient's informed consent before prescribing medicine for a use not approved by the Food and Drug Administration.

In their Ninth Legislative Report, published March, 2006, the American College of Obstetrics and Gynecology wrote,

"Assembly Member Loni Hancock introduced a bill (AB 2853) that would require that physicians disclose the FDA approval status of the drug prescribed for the patient as part of an informed consent process. ACOG-IX and CMA believe that if the drug is the standard of care and the risks and benefits are disclosed, additional and specific disclosure and informed consent of the 'off-label' status is unnecessary and could cause standard of care treatments to not be used."

A few months later, Ms. Hancock withdrew her proposed bill.

To our knowledge, no state requires a patient's informed consent before a physician can prescribe off-label medication.

The Ronald Andrew Holloway Foundation disputes the rationale of the ACOG statement. When a majority of physicians begin using a drug for a particular treatment, that drug and that treatment become the standard of care. As in the case of Cytotec, the drug can benefit the doctor more than it does the patient. There is no approved study, no FDA approval, nothing- other than massive use of a product or treatment- to qualify it as the accepted standard of care.

Despite the huge public outcry to end the practice of using Cytotec to induce labor, the American College of Obstetrics and Gynecology continues to insist that the drug is safe and is the "accepted" standard of care.