This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website.
The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.
Why This Bill Is Against Our Values:
“The Goldwater Institute has funded a nationwide lobbying effort to undermine the federal oversight of medical products, deceptively billed as “right to try” legislation. Now, three proposed federal bills (S. 204, H.R. 878 and H.R. 1020) would more appropriately each be titled “the False Hope Act,” as they expose dying patients to unregulated experimental products while offering the false hope of a cure, when many will ultimately prove ineffective, unsafe or both.” (Source: Public Citizen)
“While we support patients’ rights to access medications that could be helpful to them, this particular legislation which is expected to be voted on in the House of Representatives this week would allow unproven therapies and treatments to be administered to patients without Food and Drug Administration (FDA) notification or involvement, and with no standard for patient informed consent. The legislation would roll back essential patient safeguards and could result in patients being harmed by unproven, and potentially unsafe, therapies. Furthermore, the legislation would significantly restrict FDA’s ability to stop access to an experimental therapy and would remove expert consulting requirements on dosing and other important safety measures currently provided by FDA.
The Federal Government already allows patients to get experimental therapies through its expanded access or compassionate use program. Statistics show that FDA approves over 99 percent of such requests while preserving patient protections.
Rather than move forward with the current legislation, patient groups urge lawmakers to continue working with them to find safe ways to broaden patient access to new treatments without jeopardizing patient safety.” (Source: American Cancer Society Cancer Action Network)