I wrote about this a while back. Can’t believe it’s actually been almost two years.

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At the same time, orphan drugs are some of the costliest ones on the market right now

In the Medicare guidance document, CMS made clear they would lift the price, negotiation, exemption, even if the drug has not been approved for the additional indications. Obviously some groups were not happy about that and were looking to change it

a key point here is that FDA grants the orphan drug designation **before** approval. So you don’t know that the drug will actually work on multiple diseases or populations just because there’s a design designation for that indication

But back to the orphan drug provision in the E&C reconciliation text. Some background:

The Inflation Reduction Act exempts drugs with an FDA orphan drug designation from Medicare drug price negotiations.

But if there is more than one Orphan Drug designation, that exemption no longer applies.

Read more about last night’s bill text from @bgov.com’s @erincdurkin.bsky.social

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“That includes things like keeping the lights on, maintaining the facilities, and running institutional review boards to look at human subject [study] applications,” Collins said at a May 17, 2017 hearing.

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Francis Collins told the house spending panel at the time that forcing universities to shoulder a greater share of the “indirect” costs of grant-funded studies may make their biomedical research efforts unsustainable.

Reps. Tom Cole (R-Okla.) and Rosa DeLauro (R-Conn.), then the top GOP & Dem on Labor-H stopped the cuts. They now lead the full committee

But Rep. Andy Harris (R-Md.) was a big proponent of cutting F&A, saying that money could fund more research.

Trump 1.0 proposed similar cuts in a budget blueprint they released almost eight years ago (March 16, 2017) as part of a larger effort to slash NIH's budget by $6 billion ($32B down to $25.9B).

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Wish I had written that with fewer typos🤦🏻‍♀️🤦🏻‍♀️🤣🤣 but yes exactly