Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety

Author:Ryan Abbott
Position:Associate Professor, Southwestern Law School & Visiting Assistant Professor, David Geffen School of Medicine at University of California, Los Angeles
Pages:225-292
SUMMARY

Data on individual patients collected through state and federal health information exchanges has the potential to usher in a new era of drug regulation. These exchanges, produced by recent health care reform legislation, will amass an unprecedented amount of clinical information on drug usage, demographic variables, and patient outcomes. This information could aid the Food and Drug Administration ... (see full summary)

 
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Big Data and Pharmacovigilance:
Using Health Information Exchanges to
Revolutionize Drug Safety
Ryan Abbott
ABSTRACT: Data on individual p atients collected through state and
federal health information excha nges has the potential to usher in a new era
of drug regulation. These exchanges, prod uced by recent health care reform
legislation, will amass an unprecedented amount of clinical information on
drug usage, demographic variables, a nd patient outcomes. This informatio n
could aid the Food and Drug Administration (“FDA”) with post-market
drug surveillance because it more accurately reflects clinical p ractice
outcomes than the trials the FDA relies upon for dr ug approval. However,
even with this data available, the m arket-driven impetus to use it to polic e
drugs is weak. This is fixable; the p ost-market drug regulatory process needs
new incentives to boost third party participation. While a variety of
mechanisms could achieve this , the best option for generat ing robust results
may be an administrative bounty proceed ing that will allow third parties to
submit evidence to the FDA to contest th e claimed safety and efficacy profiles
of drugs already on the market. This Article uses a case study of Merck’s
former blockbuster drug Vioxx to demonstrate how this system might wo rk.
In creating a new incentive that co unters the powerful financial motivation
of drug manufacturers to obscu re or misrepresent safety profiles , the proposed
bounty proceeding could lead to an impro ved balance of the risks and
benefits of drugs used by the American public. More broadly , this Article
illustrates how to create an in centive for the private sector t o supplement
regulatory activity in a complex field .
Associate Professor, Southwestern Law School & Visiting Assistant Professor, David
Geffen School of Medicine at University of California, Los Angeles. M.D., University of
California, San Diego School of Medicine, 2011; J.D., Yale Law School, 2011; M.T.O.M.,
Emperor’s College, 2005; B.S., University of California, Los Angeles, 2005. Thanks to Ian Ayres,
Einer Elhauge, Barbara Evans, Jennifer Herbst, Carissa Hessick, Bonnie Kaplan, Reichi Lee,
Arthur McEvoy, Eric Orts, Jerome Reichman, William Sage, Mark Seidenfeld, Elizabeth Sepper,
and Sean Williams for their thoughtful reviews. Thanks also to Anna Aran and Danielle Doumar
for their excellent research assistance.
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226 IOWA LAW REVIEW [Vol. 99:225
I. INTRODUCTION .................................................................................... 227
A. POST-MARKET REGULATION OF DRUGS AND MEDICAL DEVICES .......... 231
1. Drug Regulation and Post-Market Assessment .................... 231
2. Randomized Control Trials Versus Observational
Studies ................................................................................... 233
3. Existing Resources in Pharmacovigilance............................ 237
4. Regulatory Shortcomings ..................................................... 240
B. THE STRUGGLE FOR ACCEPTANCE .................................................... 247
1. Health Information Technology and Health
Information Exchange ......................................................... 247
2. The Government Steps In: The HITECH Act and the
Affordable Care Act .............................................................. 251
3. Establishing Health Information Exchanges ....................... 252
II. THE FDA, PRODUCT SPONSORS, AND THIRD PARTIES .......................... 253
A. USING HIES TO POWER PHARMACOVIGILANCE .................................. 253
B. GOVERNMENT AGENCIES ................................................................. 256
C. PRODUCT SPONSORS ....................................................................... 257
D. THIRD PARTIES .............................................................................. 259
E. NEW USES AND NEW USE PATENTS ................................................... 263
F. IN SEARCH OF NEW INCENTIVES—LOOKING TO QUI TAM
LITIGATION ................................................................................... 266
G. MODELING A BOUNTY PROCEEDING AFTER AN FCA QUI TAM
ACTION ......................................................................................... 269
1. Standing and Settlement ...................................................... 270
2. Venue .................................................................................... 273
H. PAYING FOR A BOUNTY PROCEEDING ................................................ 276
I. COST BEARERS ............................................................................... 279
J. THE CHALLENGES OF CREATING A NEW INDUSTRY ............................ 282
K. A VIOXX HYPOTHETICAL ................................................................. 285
III. CONCLUDING THOUGHTS .................................................................... 291
2013] BIG DATA AND PHARMACOVIGILANCE 227
I. INTRODUCTION
Every day 2.5 quintillion bytes of data are createdso much that 90
percent of the world’s data has been produced in the last two years alone.1
This information revolution is transforming education, labor markets, and
social relationships, and is creating entirely new industries.2 Some of the
greatest advances have and will come in biotechnology and bioinformatics,
where “big data” is altering new drug development, clinical practices, and
health care financing.3 It also has the potential to lead to a new kind of
understanding of how drugs work in the real world. In 1991, the Food and
Drug Administration (“FDA”) based its approval of the cholesterol-lowering
drug simvastatin on pre-market controlled clinical studies that included a
total of 2423 patients.4 In 2011 alone, health care providers, just in the
United States, wrote almost a hundred m illion prescriptions for the drug.5
Imagine the impact of being able to analyze data from every one of those
patients to evaluate whether simvastatin is safe and effective. Better yet,
imagine analyzing data from every patient who has ever taken the drug in
every country in the world. That is the vision of a drug regulatory system
powered by big data. Historically, that type of research has been
unachievable. But now, for the first time in human history, it is a possibility.
However, it remains just thata possibility. Although a vision for a new
type of post-market regulatory system exists, a plan does not. If the vision is
to come to fruition, policymakers must address some operational challenges.
First, the right kinds of data will need to be collected. Second, researchers
have to aggregate the raw data in order to analyze it more easily. Third, the
aggregated data will need to be effectively plugged into the regulatory
process. Unfortunately, because an industry motivated by profit rather than
patient outcomes dominates our current post-market drug regulatory
system, it is not structured to meaningfully use such data. While another
stakeholder in the processthe FDAhas a different set of motivations and
political pressures, the agency lacks the resources, information, and
entrepreneurial drive of the 1.1 trillion-dollar-a-year private industry it
1. Bringing Big Data to the Enterprise, IBM, http://www-01.ibm.com/software/ph/data/
bigdata/ (last visited Sept. 20, 201 3).
2. Peter F. Drucker, Beyond the Information Revolution, ATLANTIC (Oct. 1, 1999, 12:00 PM),
http://www.theatlantic.com/magazine/archive/1999/10/beyond-the-information-revolution/
304658/.
3. See Ryan Abbott, Overcoming Barriers to a Global Treaty on Medical Funding and R&D, 7
REVISTA ELETRÔNICA DO IBPI [J. BRAZILIAN INST. FOR INTELL. PROP.] 70 (2012) (Braz.).
4. MERCK SHARP & DOHME LTD., MERCK & CO., INC., HIGHLIGHTS OF PRESC RIBING
INFORMATION: ZOCOR (SIMVASTATIN ) TABLETS 7 (2010), available at http://www.accessdata.fda.gov/
drugsatfda_docs/label/2010/ 019766s078lbl.pdf.
5. IMS INST. FOR HEALTHCARE INFORMATICS, THE USE OF MEDICIN ES IN THE UNITED
STATES: REVIEW OF 2011, at 38 (2012), available at http://www.imshealth.com/ims/Global/
Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/IHII_Medicines_in
_U.S_Report_2011.pdf.

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