AB 745

Under current law, a physician who treats a patient must inform the patient

about the availability of all alternate, viable medical modes of treatment and about

the benefits and risks of these treatments. A physician who violates this

requirement is subject to discipline by the Medical Examining Board (board) for

unprofessional conduct and may be fined up to $25,000 and imprisoned for up to 9

months. If the board finds that the physician has engaged in unprofessional conduct,

the board may warn or reprimand the physician, or limit, suspend, or revoke any

license, certificate, or limited permit granted to the physician.

Under this bill, a physician may not prescribe or use a drug or device in a

manner that constitutes an off-label use without obtaining the patient's informed

consent unless the board has determined that the off-label use is safe and effective.

The bill defines an off-label use as a use that has not been approved by the U.S.

Federal Drug Administration (FDA) to be included on the product's label. The bill

specifies that a patient's consent is informed only if the physician informs the patient

that the drug or device is being prescribed or used in a manner that is an off-label

use and of the uses for which the drug or device has been approved by the FDA.

The bill also provides that, beginning on January 1, 2014, a physician may not

prescribe or use any drug or device in which the physician has a financial interest

unless the physician obtains the patient's informed consent. Under the bill, a

physician has a financial interest in a drug or device if the physician has received

gifts or payments of more than $10 from the manufacturer and information about

those gifts or payments is available to the public on an Internet Web site. Under

federal law, information on gifts or payments of more than $10 from manufacturers

to physicians must be available to the public on an Internet Web site no later than

September 30, 2013. The bill specifies that a patient's consent is informed only if the

physician provides the patient with any information related to gifts or payments the

physician received from the manufacturer of a drug or device that is publicly

available on the Internet Web site established by the federal government.

Under the bill, a physician who fails to obtain a patient's informed consent

related to the off-label use of a drug or device or for the prescription or use of a drug

or device in which the physician has a financial interest is subject to the same

penalties as a physician who fails to inform a patient about the availability of all

alternate, viable medical modes of treatment.

Because this bill creates a new crime or revises a penalty for an existing crime,

the Joint Review Committee on Criminal Penalties may be requested to prepare a

report concerning the proposed penalty and the costs or savings that are likely to

result if the bill is enacted.