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New article with @akapczynski, forthcoming @CalifLRev!!
"The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs."
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3696503
A paper 2 years in the making, & especially topical now.
THREAD: 1/
"The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs."
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3696503
A paper 2 years in the making, & especially topical now.
THREAD: 1/
@US_FDA holds a massive reservoir of data on whether the drugs & vaccines we take are safe & effective--the world's largest. Yet it releases only a trickle to researchers, doctors, & patients. The unreleased data is an untapped resource of scientific & public health knowledge. 2/
How does safety & efficacy data get used, once made public? For one, independent researchers can double-check the work of the FDA; sometimes they see safety problems in clinical trial data that the agency missed (as occurred with rofecoxib (Vioxx)). 3/ https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1108579
Independent researchers can also use safety & efficacy to help us better direct our collective healthcare spending. We spend billions on "innovative" new drugs whose benefits over older, cheaper drugs may be minimal, or nonexistent. 4/ https://www.fiercepharma.com/pharma/want-bang-for-your-buck-don-t-look-to-sarepta-s-pricey-dmd-therapy-exondys-icer-says
The public has some tools to get secret safety & efficacy data out of the FDA, but they're difficult to use, slow, & unearth a mere fraction. FOIA was the most important tool, but it just got nerfed by SCOTUS's decision last year in FMI v Argus Leader. 5/ https://www.scotusblog.com/case-files/cases/food-marketing-institute-v-argus-leader-media/
(While FMI has made FOIA harder, Yale's @MFIAclinic & Cornell's 1A Clinic are litigating a major case, Seife v. FDA, w/ some help from Amy & me, that seeks to preserve the viability of FOIA as a tool to obtain clinical trial data from the FDA. 
) 6/ https://law.yale.edu/mfia/projects/open-data/sarepta
) 6/ https://law.yale.edu/mfia/projects/open-data/sarepta
Why doesn't @US_FDA just release this valuable information to the public proactively? For years, the pharmaceutical industry has insisted that proactive disclosure is illegal under federal statute--even criminal & unconstitutional--& the FDA has mostly acceded to that view. 7/
Pharma is wrong. FDA holds all the legal authority it needs to begin controlled disclosure of safety & efficacy data. With few exceptions, the data does not constitute a trade secret, but even if it did, the Takings Clause and federal Trade Secrets Act do not prohibit release. 8/
Our paper provides the FDA with a roadmap to an effective, practical proactive disclosure regime, which we deem "data publicity" (in explicit homage to the Progressive Era). It privileges data uses that promote public health, restricts harmful uses, & protects patient privacy. 9/
Safety & efficacy data publicity at the FDA can be achieved without legislative action, and without major costs to the agency, to improve public health & reduce drug spending. It's the kind of practical, progressive policy that a new administration might embrace in 2021.... 10/
The paper grew from work Amy & I did at @Yale_CRIT @YaleGHJP @MFIA in 2018-19, long pre-COVID, but the pandemic makes the need for data publicity more pressing than ever--to inform patient care, to accelerate R&D, & to protect the integrity of the FDA. 11/ https://www.statnews.com/2020/09/29/increase-transparency-at-the-fda-we-need-sunlight-to-fight-the-pandemic/
On COVID-19 drugs & vaccines, there are already promising pro-transparency signs from the Biden campaign, which has committed to "publicly release clinical data for any vaccine the FDA approves" & permit gov't scientists to publicize their analysis. 12/ https://joebiden.com/covid19/
I'll stop there! Too many people contributed ideas, criticism, & inspiration to name (see the Acknowledgments!), but special thanks to everyone at @Yale_CRIT, inc. @jsross119, @gregggonsalves @akapczynski, @hmkyale, @MFIADave. Truly a pleasure & privilege to work w/ you. 13/13
