4729.89 Investigational drugs.

(A) As used in this section, "eligible patient," "investigational drug, product, or device," "terminal condition," and "treating physician" have the same meanings as in section 4731.97 of the Revised Code.

(B) A manufacturer of dangerous drugs may, in accordance with section 4731.97 of the Revised Code, provide an investigational drug, product, or device for treatment of a terminal condition to an eligible patient or to the treating physician who is treating the eligible patient's terminal condition. In doing so, the manufacturer may do all of the following:

(1) Provide the investigational drug, product, or device to the eligible patient or treating physician directly or through a terminal distributor of dangerous drugs;

(2) Provide the investigational drug, product, or device either with or without charge for the costs associated with manufacturing and providing the investigational drug, product, or device;

(3) Require the eligible patient to participate in data collection relating to use of the investigational drug, product, or device.

(C) Except for actions or omissions constituting willful or wanton misconduct, a manufacturer or terminal distributor of dangerous drugs that provides or distributes an investigational drug, product, or device pursuant to this section and section 4731.97 of the Revised Code is not liable for or subject to damages in any civil action or prosecution in any criminal proceeding for actions or omissions related to providing or distributing the investigational drug, product, or device.

(D) Nothing in this section shall be interpreted as requiring a manufacturer or terminal distributor to provide an investigational drug, product, or device to an eligible patient or the patient's treating physician.

Cite as R.C. § 4729.89

Added by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.