President Donald Trump on Wednesday signed into law the “Right-to-Try” bill, but the news of the day came in a side comment when he said drug companies in the next two weeks will announce “massive drops in drug prices.” He did not offer any specifics on the voluntary price reductions.
The new law, meanwhile, will allow terminally ill patients with limited options to ask biopharma companies if they can use experimental treatments outside clinical trials.
The law is a major win for the libertarian Goldwater Institute, which has been working to undermine the FDA for years at the state level, with “Right-to-Try” legislation spreading to 40 states, though so far, only one physician has tried to use such legislation.
The Goldwater Institute said it did not know if the data from the Houston trial was used to support the application that won approval (the FDA press release says expanded access data was used in the approval).
Critics of the “Right-to-Try” legislation have made clear that dubious pop-up companies and doctors trying to make a quick buck are likely to try to take advantage of this new law. Supporters, meanwhile, claim the law offers an alternative “pathway” to accessing experimental treatments, though it remains unclear how this pathway will work. Senator Ron Johnson (R-WI) did not offer any additional details on how he thought the pathway will be implemented.
FDA Commissioner Scott Gottlieb said in a statement: “At the FDA, we stand ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients.”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
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