Evidence map›Paper›PMID 30471089›Full record

ArticleClinical pharmacology and therapeutics2019

Generic Drugs in the United States: Policies to Address Pricing and Competition.

Ravi Gupta, Nilay D Shah, Joseph S Ross

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Trial
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  11. Article
  12. Review
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  14. A comprehensive quality control and cost comparison study of branded and generic angiotensin receptor blockers.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024
    Article
  15. Article
  16. Article
  17. Article
  18. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Ravi GuptaDepartment of Medicine, Johns Hopkins Hospital and Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Nilay D ShahDivision of Health Care Policy and Research, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA.
Joseph S RossDepartment of Medicine, Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.

Funding

Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
PA-20-072: Accelerating the Use of Evidence-based Innovation in Healthcare SystemsU19HS024075 · AHRQ · DARTMOUTH COLLEGE · PI MEARA, ELLEN R. · 2015 to 2021
$19.8M
Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)R01HL131535 · NHLBI · MAYO CLINIC ROCHESTER · PI MONTORI, VICTOR MANUEL · 2016 to 2020
$3.2M
Understanding hospital value: provider, hospital and community effectsR01HS022882 · AHRQ · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI HORWITZ, LEORA · 2014 to 2023
$2.9M
Gastrointestinal Safety of Antithrombotic Drug RegimensR01HS025402 · AHRQ · MAYO CLINIC ARIZONA · PI ABRAHAM, NEENA S · 2017 to 2020
$1.6M
Medical reversals: De-implementing ineffective and unsafe treatmentsR01HS025164 · AHRQ · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2017 to 2020
$1.4M
Diffusion of Clinical Evidence into Practice: Physician Networks, Delivery Organizations, and MarketsR56HL130496 · NHLBI · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2016 to 2016
$634k
Optimizing Medical Device Post-Market Surveillance for Public ValueU01FD004585 · FDA · YALE UNIVERSITY · PI KRUMHOLZ, HARLAN MARC · 2012 to 2016
$592k
The ICAN Discussion Aid to Optimize Treatment for People Living with Multiple Chronic ConditionsR03HS025517 · AHRQ · MAYO CLINIC ROCHESTER · PI SHAH, NILAY D · 2017 to 2018
$100k
AHRQ HHS R01 HS022882AHRQ HHS R01 HS025164AHRQ HHS R01 HS025402AHRQ HHS R03 HS025517AHRQ HHS U19 HS024075FDA HHS U01 FD004585FDA HHS U01 FD005938NHLBI NIH HHS R01 HL131535NHLBI NIH HHS R56 HL130496
6 · The paper itself

Abstract

The cost of prescription drugs in the United States continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive US Food and Drug Administration (FDA) approval and enter the market, but the past decade has witnessed rising costs and shortages of generic drugs. We describe the strategies used by brand-name manufacturers to undermine generic competition and the reasons underlying the price increases of off-patent drugs, some of which continue to lack any competition from generic versions, and others that have increased in price despite having generic versions. We discuss the FDA's role in addressing drug prices and promoting competition, including recent agency policies to modify its process of reviewing generic drug applications and to prioritize applications for off-patent drugs with few competitors. We also examine proposed policy solutions and research areas that could help address the price increases of off-patent drugs.

Indexed as

Costs and Cost AnalysisDrug ApprovalDrug CostsDrug IndustryDrugs, GenericEconomic CompetitionHumansLegislation, DrugPolicyPrescription DrugsUnited StatesUnited States Food and Drug AdministrationDrugs, GenericPrescription Drugs

Identifiers

PMID30471089
PMCPMC6355356

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.