I just wrote this piece on Right To Try laws that is now published on the Health Affairs Blog. Hope you find it interesting – I’m very skeptical of the whole thing, since drug companies are not compelled or likely interested in supplying experimental drugs for little or no reimbursement.
Thanks Jonathan! Sure is food for thought and not a “no-brainer fer sure I would guess Mary Sue.
I worked in a regulated industry (aerospace) where our designs were certified by the government as meeting the federal requirements and therefore safe to be used by the aviation community. But that was only half the story.
Our production and quality control facilities were also federally certified to a different set of regulations after proving that production could actually make the certified design consistently, and safely in the quantities needed. We developed our production facilities in parallel with the need to produce the parts that would undergo the extensive testing need to show compliance to the regulations and would invest 100’s of millions of dollars in such activities. But there are smaller firms that can really struggle financially during the process and must really mind their resources carefully
I imagine the same holds true with the drug companies and the FDA; The design of the drug is first certified and then their production facilities. I imagine the early production facilities could be very small and maxed out producing what’s needed to support the trial phases and having to divert some of those drugs could be a considerable distraction to the company, particularly a smaller company. I could even see it delaying approval of the drug.
But that’s all speculation on my part from a COMPLETELY different but still regulated industry. But I do know regulators and, even those in different countries with a completely different culture and they all think very much alike. Me thinks it’s in their DNA.
Nice article and thanks Jonathan.
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