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I love @PolitiFact, but this time their fact-check needs a fact-check. They're wrong & @SenatorBaldwin is right: Americans do indeed pay the highest prices in the world for remdesivir because the Trump administration let Gilead Sciences jack up the prices. Here comes a THREAD: 1/ https://twitter.com/PolitiFactWisc/status/1333897653336350727
Error #1: Politifact claims the US govt has no authority to tell drug companies what to charge. That's generally true (federal statute prohibits Medicare & other govt payers from negotiating drug prices; we need Congress to amend the statute!), but false for remdesivir. 2/
Why? In June, @HHSGov made the unusual move of contracting directly with Gilead to "secure[] more than 500,000 treatment courses of the drug for American hospitals through September." (Those courses were more than 90% of Gilead's entire global supply!) 3/ https://www.hhs.gov/about/news/2020/06/29/trump-administration-secures-new-supplies-remdesivir-united-states.html
HHS contracted directly with Gilead & then redistributed remdesivir to hospitals around the country, short-circuiting usual purchasing channels. This unusual deal, cut in the midst of a national emergency, was not subject to normal statutory prohibitions on bargaining (AFAIK). 4/
HHS had enormous leverage to negotiate a lower price from Gilead--it promised to provide Gilead with a guaranteed market for millions of doses!--and squandered that leverage. As a result, "Americans do pay more for remdesivir than people elsewhere," as Politifact acknowledges. 5/
Error #2: Even though HHS squandered its leverage, HHS can still use other existing legal authority to bring down the price of remdesivir. Sen Baldwin is entirely right that HHS's compulsory patent licensing authority could be used to acquire lower-cost versions of the drug. 6/
(SHAMELESS PLUG: With @xianurrutia, @jbkrell, @PrEP4AllNow & @charles_duan, I've written about how HHS could use its compulsory licensing authority under a longstanding federal law--28 USC 1498--to purchase low-cost generic remdesivir.) 7/ https://www.statnews.com/2020/07/02/powerful-law-gives-hhs-right-to-control-remdesivir-manufacturing-distribution/
Politifact observes, correctly, "a renewed push" to "rely on compulsory licensing authority due to rising drug costs." But it then suggests, incorrectly, that this authority is somehow illegitimate, citing a recent @thehill op-ed by @ProfSeanOConnor. 8/ https://thehill.com/opinion/healthcare/527231-no-the-government-cannot-seize-break-or-bypass-pharmaceutical-patents-even
Quoting Prof. O'Connor, Politifact claims "by using compulsory licensing, the government would essentially be stealing the patent for remdesivir from Gilead" and that "the government is not authorized to infringe on patents any more than everyday individuals." 9/
With due respect, this is wrong. As @Maybarduk & I wrote in response to a similarly misguided op-ed, "compulsory licensing of patents and other intellectual property is enshrined in U.S. federal law." It is perfectly legal and has been for decades. 10/ https://www.wsj.com/articles/the-remdesivir-patent-and-treating-covid-11599585956
Under § 1498, HHS is fully legally authorized to "use" privately held patents on drugs and all other technologies on the public's behalf, in exchange for statutorily guaranteed "reasonable and entire compensation"--money damages, set at market rate--paid to the patent holder. 11/
In fact, in 2001, the not-so-radical George W Bush administration openly contemplated use of § 1498 to purchase low-cost antibiotics from generic suppliers when the patent holder on the brand-name version refused to supply enough drug at a fair price. 12/ https://www.wsj.com/articles/SB1003966074330899280
(SHAMELESS PLUG: @charles_duan traces the history of the Bush administration's contemplated use of § 1498 in 2001 in our forthcoming paper, "Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crises.") 13/ https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3685413
Contrary to Politifact's fact check, the Trump administration could exercise its § 1498 authority TODAY to begin the process of bringing low-cost generic remdesivir to the US. Charles & I explain how in our paper. 14/ https://twitter.com/cmorten2/status/1303689409158696960?s=20
2 final thoughts: 1. Remdesivir's price is outrageous in part bc its therapeutic value is murky at best. As @reshmagar & @rgupta729 have written, Gilead & @US_FDA must generate more & better evidence on whether remdesivir actually helps COVID patients. 15/ https://www.nytimes.com/2020/11/17/opinion/remdesivir-covid-fda.html
2. Remdesivir's price is more outrageous still given the unusually large investment (>$70M) the US govt made in the drug's discovery & development. @zainrizvi @Public_Citizen @PCMedsAccess have the receipts. 16/ https://www.citizen.org/article/the-real-story-of-remdesivir/
(SHAMELESS PLUG: In May, @jbkrell & I published an analysis of the many contributions US govt scientists made to the discovery & development of remdesivir. We made a case that the US govt is rightful co-owner of the most important patents on the drug.) 17/ https://static1.squarespace.com/static/5e937afbfd7a75746167b39c/t/5ecd886c5699191ae9bad9ea/1590528109403/The+U.S.+Government%27s+Apparent+Co-Ownership+of+Patents+Protecting+Remdesivir+-+P4A+%26+NYU.pdf
TLDR: Whatever remdesivir's therapeutic value, Americans currently pay much more than they should. @SenatorBaldwin is right that the Trump administration, and soon Biden, have legal authority to take action to bring prices down. HHS has the tools. It just needs the will. 18/18
If still unsure whether HHS can legally buy low-cost generic drugs, despite patents, listen to @SecAzar, who wrote in 2002, "Section 1498(a) permits the United States to procure items without first obtaining a license, so long as it pays reasonable and entire compensation." 19/21
Now-Secretary Azar was then HHS's GC. He had just emerged from negotiations with Bayer in which HHS, after threatening compulsory licensing, negotiated lower prices on an antibiotic (Cipro). In Azar's own words, HHS "saved taxpayers money" & "really drove down the price." 20/21
(LAST SHAMELESS PLUG: For the full story, check out "Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crises" with @charles_duan. We cite Azar's letter at footnote 33.) 21/21 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3685413
