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S.F. No. 100 - Right to Try Act (Second Engrossment)
 
Author: Senator Branden Petersen
 
Prepared By: Katie Cavanor, Senate Counsel (651/296-3801)
 
Date: April 21, 2015



 

S.F. No. 100 permits eligible patients to use an investigational drug, biological product, or device that has successfully completed phase 1 of a clinical trial, but has not been approved for general use by the federal Food and Drug Administration (FDA) and is currently under investigation in a FDA clinical trial.

Section 1 (151.375) establishes the use of investigational drugs.

Subdivision 1 states that this section may be cited as the “Right to Try Act”.

Subdivision 2 defines the following terms:  eligible patient; investigational drug, biological product, or device; and terminal illness.

Subdivision 3 states that for a patient to be eligible in terms of this section, a physician must document in writing that the patient has (1) a terminal illness; (2) considered all other treatment options currently approved by the FDA, in consultation with a physician; (3) been given a prescription or recommendation by a physician for an investigational drug, biological product, or device; and (4) given a written informed consent for the use of the investigational drug, biological product, or device, or if the patient is under the age of 18 or lacks the mental capacity to provide informed consent and a parent or legal guardian has given informed consent on behalf of the patient.

Subdivision 4 permits a drug manufacturer to make investigational drugs, biological products, or devices to an eligible patient, but is not required to make them available.

Subdivision 5 permits a manufacturer to provide the investigational drug, biological product, or devise to an eligible patient without compensation, but also permits the manufacturer to require the patient to pay costs associated with the drug, product, or device.

Subdivision 6 specifies that no occupational or professional licensing board shall subject a health care provider to a civil penalty or disciplinary action solely based on the licensee providing a prescription or recommendation or providing treatment to an eligible patient that involves the use of an investigational drug, biological product, or device in accordance with this section.  Specifies that a professional licensing board may take action against a health care provider for violations of other sections of law.

Subdivision 7 specifies that private insurance, state public health care programs, the state employee group insurance program, and programs administered by a state or local government agency that provide health care services to inmates residing in state or county correctional facilities are not required to cover the cost of an investigational drug, biological product, or device.

Subdivision 8 specifies that there is no cause of action against a health care provider or entity for any harm caused to an eligible patient from an investigational drug, or biological production device, so long as the provider or entity is complying in good faith with the requirements of the section.

Subdivision 9 provides for a severability provision.

 
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