{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:58:21Z","timestamp":1790621901616,"version":"4.1.0"},"reference-count":15,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,6,7]],"date-time":"2023-06-07T00:00:00Z","timestamp":1686096000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:p>In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval to aducanumab, a monoclonal antibody indicated for the treatment of Alzheimer's disease. The accelerated approval decision was controversial due to concerns about the use of an unvalidated surrogate measure, beta\u2010amyloid, as the basis for approval and a lack of clinical outcome benefit. Between October 2021 and September 2022, we conducted a survey of a nationally representative group of internists, medical oncologists, and cardiologists to understand perspectives around aducanumab's approval and how this FDA decision may influence trust in other drugs approved through the accelerated approval program. Among 214 physician respondents familiar with the accelerated approval of aducanumab, 184 (86%) would not prescribe or recommend aducanumab. Further, 143 (67%) physicians reported losing trust in other drugs approved through the accelerated approval program due to the FDA's decision with aducanumab. As a growing number of similar novel Alzheimer's disease treatments are on the horizon, the first of which, lecanemab, already has received accelerated approval in January 2023, our survey findings provide insight into the impact of the FDA's regulatory decisions on the perspectives and prescribing behavior of physicians concerning these novel drug treatments.<\/jats:p>","DOI":"10.1002\/cpt.2954","type":"journal-article","created":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T10:38:53Z","timestamp":1684838333000},"page":"614-617","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease"],"prefix":"10.1111","volume":"114","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0674-2032","authenticated-orcid":false,"given":"Sanket S.","family":"Dhruva","sequence":"first","affiliation":[{"name":"Section of Cardiology, Department of Medicine San Francisco Veterans Affairs Medical Center  San Francisco California USA"},{"name":"Philip R. Lee Institute for Health Policy Studies University of California, San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8867-2666","authenticated-orcid":false,"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"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 Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Woloshin","sequence":"additional","affiliation":[{"name":"Dartmouth Institute for Health Policy and Clinical Practice  Lebanon New Hampshire USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin Z.","family":"Ji","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine University of California San Francisco School of Medicine  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhigang","family":"Lu","sequence":"additional","affiliation":[{"name":"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 Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan J.","family":"Darrow","sequence":"additional","affiliation":[{"name":"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 Massachusetts USA"},{"name":"Department of Law and Taxation Bentley University  Waltham Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita F.","family":"Redberg","sequence":"additional","affiliation":[{"name":"Philip R. Lee Institute for Health Policy Studies University of California, San Francisco  San Francisco California USA"},{"name":"Division of Cardiology, Department of Medicine University of California San Francisco School of Medicine  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,6,7]]},"reference":[{"key":"e_1_2_8_1_1","unstructured":"Code of Federal Regulations.21 CFR 314.510. Part 314 \u2013 applications for FDA approval to market a new drug. 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