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Wednesday at the BIO International Convention was all about policy—from the FDA Commissioner talking about Accelerated Approval and challenges to the FDA’s authority, to panels on price controls and state advocacy. A few highlights below, plus what you might have missed in D.C. this week. (581 words, 2 minutes, 54 seconds) |
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How to follow Good Day BIO Live |
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- Follow Bio.News for panel recaps, exclusive Q&As, and much more.
- Join the conversation on Twitter with @IAmBiotech and the hashtag #BIO2023. Watch for exclusive video content and repost-worthy quotes, and tell us what you're discovering!
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Merck's supporting colleagues working with cancer
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There are so many unknowns after a cancer diagnosis – whether or not you receive support at work shouldn’t be one of them. Chet had no idea how his battle with cancer would affect his work. Watch to see how support from his colleagues and company made a world of difference in his recovery.
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FDA Commissioner on COVID lessons, Accelerated Approval, and more |
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Dr. Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), joined BIO CEO Rachel King for a wide-ranging conversation on the mainstage—here’s what he said. On lessons from COVID:
He discussed important topics including One Health, public-private partnership, and combating misinformation—watch: |
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On legal challenges to FDA’s authority:
“I can’t say really much of anything about the particular case except that we’re confident in the decisions that have been made, about the FDA’s decision-making in this case made by experts with access to all the latest scientific data. And, you know, this is something that’s been ongoing for over 20 years, and the data really haven’t changed,” he said. “And so we think it’s very important that that fundamental statutory basis for the existence of FDA continues to stay intact. And, you know, the implications of this go beyond your industry, obviously, big implications for patients and many other parts of society.” He also talked about drug prices and shortages, Accelerated Approval, and advisory committees—read more on Bio.News. |
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Breaking down IRA’s challenges for drug makers and patients |
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Two panels at the BIO International Convention yesterday grappled with the challenges posed by the Inflation Reduction Act (IRA). To sum it up: Investors and drug company representatives analyzed the devastating impact IRA policies will have on drug development and new treatments and cures.
Here’s how: The law discourages new small molecule drugs, incremental improvements, and other good practices—while encouraging arbitrary choices that can make drugs harder to develop, administer and afford, agreed panelists in a session moderated by BIO’s Chief Advocacy Officer Nick Shipley.
The patient view: Obstacles to developing orphan drugs include disincentivizing the exploration of second indications, said patient advocates in a panel moderated by BIO’s Chief Policy Officer John Murphy. A new lawsuit: Merck is suing the federal government, calling the drug price controls unconstitutional "extortion." To quote the Wall Street Journal Editorial Board, "If Congress can leverage the threat of ruinous penalties to reduce Medicare drug prices, what’s to stop it from doing the same for healthcare provider payments or defense equipment that politicians believe are too costly? At this Hotel California, businesses don’t even get a choice of whether to check in or leave." A couple more policy stories from Day 3: |
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News from Capitol Hill: IP, PIPs, and more |
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