Later this month I will join a number of patients and biotechs who will be meeting with
@US_FDA to discuss the importance of the department codifying its stance towards state Right to Try, Right to Personalized Treatment, and stem cell laws.
Since 2016 when
@SenRonJohnson first asked HHS and FDA to clarify their enforcement stance towards state programs, and was rebuffed, there has never been an official stance on this issue clarified.
Yet, in the 10 years since, HHS and FDA have never actually escalated to enforcement against a doctor or biotech using a state Right to Try program. In one high profile example, they actually granted a drug priority breakthrough status after it was used successfully on 75 patients under Texas Right to Try.
To some extent they have clearly been exercising enforcement discretion, which is the right thing for them to do! It's not a good use of their resources to go after companies sending medicine to patients for use under a state law.
But, this position being "unwritten" is actively blocking patients from receiving care. And it's time for their position on the matter, whatever it may be, to be made official.
These programs represent a chance to catch patients who fall through the cracks in the Federal patient access system. And the fact more and more states continue to pass new laws even today demonstrates a clear mandate from the American people to allow the states to step up to the plate, and get their patients medicine.