Literature DB >> 21680577

Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

Samantha A Roberts1, Jeff D Allen, Ellen V Sigal.   

Abstract

The US Food and Drug Administration is often criticized as inefficient compared to its European counterpart, the European Medicines Agency. This criticism is especially common in the field of oncology, where severely ill patients have few therapeutic options. We conducted a direct drug-to-drug comparison of the two regulatory agencies' approvals of new oncology drugs. We found that contrary to public assertions, the median time for approval for new cancer medicines in the United States was just six months--and that these new anticancer medicines are typically available in the United States before they are in Europe. Our findings reinforce the need for strong financial and public support of the Food and Drug Administration, so that such medicines can continue to be made available speedily to patients in need.

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Year:  2011        PMID: 21680577     DOI: 10.1377/hlthaff.2011.0231

Source DB:  PubMed          Journal:  Health Aff (Millwood)        ISSN: 0278-2715            Impact factor:   6.301


  18 in total

1.  Regulatory review of novel therapeutics--comparison of three regulatory agencies.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Joel B Braunstein; Harlan M Krumholz; Joseph S Ross
Journal:  N Engl J Med       Date:  2012-05-16       Impact factor: 91.245

2.  Policy reform: Strengthen and stabilize the FDA.

Authors:  Daniel Carpenter
Journal:  Nature       Date:  2012-05-09       Impact factor: 49.962

Review 3.  A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.

Authors:  Rashmi R Shah; Samantha A Roberts; Devron R Shah
Journal:  Br J Clin Pharmacol       Date:  2013-09       Impact factor: 4.335

4.  A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

Authors:  Minette-Joëlle Zeukeng; Enrique Seoane-Vazquez; Pascal Bonnabry
Journal:  Eur J Clin Pharmacol       Date:  2018-02-22       Impact factor: 2.953

5.  An analysis of whether higher health care spending in the United States versus Europe is 'worth it' in the case of cancer.

Authors:  Tomas Philipson; Michael Eber; Darius N Lakdawalla; Mitra Corral; Rena Conti; Dana P Goldman
Journal:  Health Aff (Millwood)       Date:  2012-04       Impact factor: 6.301

6.  Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.

Authors:  Mark P Lythgoe; Aakash Desai; Bishal Gyawali; Philip Savage; Jonathan Krell; Jeremy L Warner; Ali Raza Khaki
Journal:  JAMA Netw Open       Date:  2022-06-01

7.  Comparison of Cancer-Related Spending and Mortality Rates in the US vs 21 High-Income Countries.

Authors:  Ryan D Chow; Elizabeth H Bradley; Cary P Gross
Journal:  JAMA Health Forum       Date:  2022-05-27

8.  User fees and beyond--the FDA Safety and Innovation Act of 2012.

Authors:  Daniel B Kramer; Aaron S Kesselheim
Journal:  N Engl J Med       Date:  2012-10-04       Impact factor: 91.245

9.  Developing standards for breakthrough therapy designation in oncology.

Authors:  Sandra J Horning; Daniel A Haber; Wendy K D Selig; S Percy Ivy; Samantha A Roberts; Jeff D Allen; Ellen V Sigal; Charles L Sawyers
Journal:  Clin Cancer Res       Date:  2013-05-29       Impact factor: 12.531

10.  FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements.

Authors:  Dickran Kazandjian; Gideon M Blumenthal; Huan-Yu Chen; Kun He; Mona Patel; Robert Justice; Patricia Keegan; Richard Pazdur
Journal:  Oncologist       Date:  2014-08-28
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