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BMJ. 2018 Mar 19;360:k831. doi: 10.1136/bmj.k831.

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

Author information

1
Department of Medicine, Johns Hopkins Hospital and Johns Hopkins School of Medicine, Baltimore, MD, USA.
2
Global Health, Economics, and Development, Council on Foreign Relations, Washington, DC, USA.
3
Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.
4
Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA.
5
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
6
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA akesselheim@partners.org.

Abstract

OBJECTIVES:

To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world.

DESIGN:

Observational study.

SETTING:

Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017.

STUDY COHORT:

Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions.

MAIN OUTCOME MEASURES:

Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015.

RESULTS:

Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated for treating cardiovascular diseases, diabetes, or hyperlipidemia (19, 17%); psychiatric disease (16, 15%); and infectious diseases (15, 14%). In 2015, Medicaid alone spent nearly US$700m (£508m; €570m) on generic drugs without adequate US competition that could have had a manufacturer approved by non-US peer regulatory agencies.

CONCLUSION:

In this study, more than half the off-patent drugs with no generic competition in the USA had at least one independent manufacturer approved by a non-US peer regulatory agency; slightly fewer than half had four or more total manufacturers. Facilitating US patient access to such manufacturers could help sustain affordable access to essential off-patent drugs.

PMID:
29555641
PMCID:
PMC5858606
DOI:
10.1136/bmj.k831
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the Laura and John Arnold Foundation, Engelberg Foundation, Harvard Program in Therapeutic Science, and Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; in 2017, TJB and ASK received honorariums from the Brookings Institution for taking part in a conference on drug pricing at the Hutchins Center in which they presented their paper “Can drug importation address high generic drug prices”; ASK has received grants from the FDA Office of Generic Drugs and Division of Health Communication (2013-16); JSR receives support through Yale University from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation program, from Medtronic, and the Food and Drug Administration to develop methods for postmarket surveillance of medical devices, from Johnson and Johnson to develop methods of clinical trial data sharing, from the Centers for Medicare and Medicaid Services to develop and maintain performance measures that are used for public reporting, from the Blue Cross Blue Shield Association to better understand medical technology evaluation, and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale; no other relationships or activities that could appear to have influenced the submitted work.

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