1/ In 2008, @US_FDA phased out #albuterol inhalers w/ ozone-depleting CFCs, including several generics.
Since then, brand-name firms have reaped $14 billion in sales on albuterol products--though the active ingredient went off #patent in 1989!
nejm.org/doi/full/10.10…
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2/ The first #albuterol inhalers came to the market in 1981.
By the mid-1990s, inexpensive generics had become available.
3/ However, many early inhalers contained chlorofluorcarbons (CFCs).
Brand-name firms, in turn, developed more environmentally friendly #HFA and dry-powder (#DPI) #albuterol inhalers.
By their own estimates, they spent $250-400 million developing these products.
4/ But with new #patent thickets on their products, brand-name manufacturers of newer #HFA and #DPI #albuterol inhalers managed to prevent generic competition until 2020.
fda.gov/news-events/pr…
5/ What did this mean for patients?
@AnupamBJena @pkmandic & others showed @JAMAInternalMed that mean out-of-pocket costs for albuterol inhalers doubled for patients following the CFC-ban.
ja.ma/3r2QIq3
6/ What did the ban mean for brand-name albuterol manufacturers?
$14 billion in revenue—and counting.
7/ Inhaler manufacturers, in general, have been extremely adept over the past 3 decades in using the #patent and #regulatory system to limit generic competition.
healthaffairs.org/doi/abs/10.137…
8/ A big part of the strategy has been obtaining #patents on delivery devices. By contrast, the same inhaled medications sold separately from their devices have faced much earlier generic competition.
nature.com/articles/s4158…
9/ We think the story of #albuterol is a cautionary tale for policymakers and @US_FDA.
10/ Brand-name firms have begun developing even more #environmentally friendly inhalers—which is great! #HFA inhalers themselves are potent emitters of greenhouse gases.
11/ But brand-name firms must not be allowed to reap outsized rewards for developing these products, as they did with #albuterol inhalers.
12/ We argue that @CMSGov should determine what reimbursement rate is appropriate for any #greener inhalers that gain approval (over and above reimbursement rates for #HFA inhalers) considering the environmental benefits they provide.
13/ Such assessment could eventually guide #Medicare #negotiation in time—or, before then, could provide a basis from which plans may negotiate.
14/ We also applaud efforts for further collaboration b/w @US_FDA & @uspto to ensure that only high-quality patents are issued.
15/ And we argue #generic manufacturers of complex products like #inhalers should get more than 180 days of exclusivity for challenging patents on brand-name drugs. This may help expedite #generic entry for drugs, including future #greener inhalers.
16/ Great as always to think about these issues w/ wonderful collaborators @ojwouters @SeanTu2 @PORTAL_Research.
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