***6/8/18 Update*** President Trump signed S. 204, now Public Law No: 115-173, into law on May 30th.

***5/23/18 Update*** The House passed S. 204 on Tuesday in a 250-169 vote in favor of the measure.


The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right to Try’ bill passed by the Senate in August 2017. House Majority Leader Kevin McCarthy announced last week that the House vote was imminent. The bill would add certain new sections to Chapter V of the Food, Drug, and Cosmetic Act (FDCA), which was previously amended by Section 3032 of the 21 Century Cures Act to require pharmaceutical manufactures to publish their policies regarding expanded access to investigational drugs. The new provisions would apply to compassionate use of an “eligible investigational drug”, or certain drugs and biologics for which a clinical trial to support a filed New Drug Application (NDA) or Biologic Licensing Application (BLA) is underway and for which a Phase 1 clinical trial has been completed. This compassionate use would be available to “eligible patients”, certain terminally ill patients who have exhausted all treatment options and are unable to enroll in a clinical trial for the eligible investigational drug, if certain conditions are met.

If passed, S. 204 would, among other things, limit the circumstances in which the Secretary of the U.S. Department of Health and Human Services (HHS) may use clinical outcome data derived from an expanded use of an eligible investigational drug to delay or adversely affect the review and approval of the drug to situations in which the drug’s sponsors request the use or the Secretary determines that the clinical outcome data is critical to determining the safety of the eligible investigational drug. In addition, S. 204 would limit the tort actions that can be brought against a prescriber, dispenser, drug sponsor or manufacturer, or any other individual entity who provides access to an eligible investigational drug. Further, S. 204 would require drug manufacturers or sponsors who provide expanded access to eligible investigational drugs to submit an annual report of those uses, including any adverse reactions caused by the drug, to HHS. HHS would make a summary of these reports publicly available on its website.

S. 204 states that it would not create a new right to access eligible investigational drugs. Under S. 204, prescribers, dispensers, sponsors and manufacturers are expressly protected from liability for refusing an eligible patient’s request to expanded access. Nor would S. 204 create any new mandates or directives, such as a requirement that drug sponsors or manufacturers establish an expanded access program or provide expanded access in any case.

If S. 204 is passed as drafted by the House, the bill will be sent to President Trump for signature.

 

Posted by Amy N. Westergren