Obtaining informed consent for the prescription and use of drugs and devices and granting rule-making authority

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.