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BMJ
2018 ; 360
(?): k831
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Affordability and availability of off-patent drugs in the United States-the case
for importing from abroad: observational study
#MMPMID29555641
Gupta R
; Bollyky TJ
; Cohen M
; Ross JS
; Kesselheim AS
BMJ
2018[Mar]; 360
(?): k831
PMID29555641
show ga
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.
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