Today the Department of Health and Human Services (HHS) issued its final rule for Medicare Part D which does not include the full range of proposed changes to drugs in the ‘six protected classes’ of cancer, epilepsy, HIV/AIDS, mental illness and organ transplants.
Patient Safety in Jeopardy Under Senate Right-to-Try Proposal
More than 100 Groups Opposed to Proposal, Call for Improved Safety Measures
WASHINGTON, D.C. – The American Cancer Society Cancer Action Network (ACS CAN), Friends of Cancer Research (FOCR), and the National Organization for Rare Disorders (NORD) along with more than 100 advocacy groups representing millions of patients submitted a letter to Members of the House of Representatives strongly opposing the Senate Right-to-Try Act (S. 204).
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.
A copy of the letter sent to Members of the House of Representatives can be found here.