Search Results Search Sort by RelevanceMost Recent Policy Forum Jul 2016 Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad Jing Luo, MD and Aaron S. Kesselheim, MD, JD, MPH The Trans-Pacific Partnership Agreement could affect low-income patients’ access to medicines in signatory countries by reducing generic competition. AMA J Ethics. 2016;18(7):727-735. doi: 10.1001/journalofethics.2016.18.7.pfor1-1607. Policy Forum Aug 2019 Should a Law Governing the Pharmaceutical Market Be Ethically Examined Based on Its Intent or Its Practical Applications? Jordan M. Warchol, MD, MPH In 1984, Hatch-Waxman tried to balance drug innovation against availability; it was tested in the US Supreme Court in 2013. AMA J Ethics. 2019;21(8):E661-667. doi: 10.1001/amajethics.2019.661. Policy Forum Aug 2019 Why Are Biosimilars Not Living up to Their Promise in the US? Mike Z. Zhai, Ameet Sarpatwari, JD, PhD, and Aaron S. Kesselheim, MD, JD, MPH Overall utilization of the few biosimilars currently available to patients has been limited. AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668. Policy Forum Mar 2020 What Should Health Care Organizations Do to Reduce Billing Fraud and Abuse? Katherine Drabiak, JD and Jay Wolfson, DrPH, JD Upcoding and misrepresenting clinical information constitute fraud, cost a lot, and can result in patient harm and unnecessary procedures and prescriptions. AMA J Ethics. 2020;22(3):E221-231. doi: 10.1001/amajethics.2020.221. Policy Forum May 2022 What Should Dietary Supplement Oversight Look Like in the US? Elizabeth Richardson, MSc, Farzana Akkas, MSc, and Amy B. Cadwallader, PhD Statutory limitations prevent the FDA from effectively regulating dietary supplements and have generated numerous calls for reform. AMA J Ethics. 2022;24(5):E402-409. doi: 10.1001/amajethics.2022.402. Policy Forum May 2022 Which Features of Dietary Supplement Industry, Product Trends, and Regulation Deserve Physicians’ Attention? Amy B. Cadwallader, PhD and AMA Council on Science and Public Health Illegal, fraudulent, adulterated, or improperly labeled products should be regarded as sources of possible clinical and ethical harm to patients. AMA J Ethics. 2022;24(5):E410-418. doi: 10.1001/amajethics.2022.410. Policy Forum Feb 2023 What the COVID-19 Pandemic Teaches Us About Pediatric Iatrogenic Risk Katherine Pumphrey, MD, MHA and Jessica Hart, MD, MHQS Pediatricians have been forced to navigate diagnostic uncertainty, hospital closures, limited staffing, and new infection control guidelines. AMA J Ethics. 2023;25(2):E130-132. doi: 10.1001/amajethics.2023.130. Policy Forum Sep 2022 Roles of Environmental Services Workers’ Wages and Status in Patient Safety David Sine, DBioethics and Lloyd Duplechan This article offers a risk management standpoint on environmental services as a mission-critical function of any health care organization. AMA J Ethics. 2022;24(9):E876-882. doi: 10.1001/amajethics.2022.876. Policy Forum Jun 2006 Reputation, Gatekeeping, and the Politics of Post-Marketing Drug Regulation Daniel Carpenter, PhD Virtual Mentor. 2006;8(6):403-406. doi: 10.1001/virtualmentor.2006.8.6.pfor1-0606. Policy Forum Oct 2004 The Universal Protocol Dennis S. O'Leary, MD Virtual Mentor. 2004;6(10):456-458. doi: 10.1001/virtualmentor.2004.6.10.pfor1-0410. Pagination Current page 1 Page 2 Next page Next › Last page Last »
Policy Forum Jul 2016 Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad Jing Luo, MD and Aaron S. Kesselheim, MD, JD, MPH The Trans-Pacific Partnership Agreement could affect low-income patients’ access to medicines in signatory countries by reducing generic competition. AMA J Ethics. 2016;18(7):727-735. doi: 10.1001/journalofethics.2016.18.7.pfor1-1607.
Policy Forum Aug 2019 Should a Law Governing the Pharmaceutical Market Be Ethically Examined Based on Its Intent or Its Practical Applications? Jordan M. Warchol, MD, MPH In 1984, Hatch-Waxman tried to balance drug innovation against availability; it was tested in the US Supreme Court in 2013. AMA J Ethics. 2019;21(8):E661-667. doi: 10.1001/amajethics.2019.661.
Policy Forum Aug 2019 Why Are Biosimilars Not Living up to Their Promise in the US? Mike Z. Zhai, Ameet Sarpatwari, JD, PhD, and Aaron S. Kesselheim, MD, JD, MPH Overall utilization of the few biosimilars currently available to patients has been limited. AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668.
Policy Forum Mar 2020 What Should Health Care Organizations Do to Reduce Billing Fraud and Abuse? Katherine Drabiak, JD and Jay Wolfson, DrPH, JD Upcoding and misrepresenting clinical information constitute fraud, cost a lot, and can result in patient harm and unnecessary procedures and prescriptions. AMA J Ethics. 2020;22(3):E221-231. doi: 10.1001/amajethics.2020.221.
Policy Forum May 2022 What Should Dietary Supplement Oversight Look Like in the US? Elizabeth Richardson, MSc, Farzana Akkas, MSc, and Amy B. Cadwallader, PhD Statutory limitations prevent the FDA from effectively regulating dietary supplements and have generated numerous calls for reform. AMA J Ethics. 2022;24(5):E402-409. doi: 10.1001/amajethics.2022.402.
Policy Forum May 2022 Which Features of Dietary Supplement Industry, Product Trends, and Regulation Deserve Physicians’ Attention? Amy B. Cadwallader, PhD and AMA Council on Science and Public Health Illegal, fraudulent, adulterated, or improperly labeled products should be regarded as sources of possible clinical and ethical harm to patients. AMA J Ethics. 2022;24(5):E410-418. doi: 10.1001/amajethics.2022.410.
Policy Forum Feb 2023 What the COVID-19 Pandemic Teaches Us About Pediatric Iatrogenic Risk Katherine Pumphrey, MD, MHA and Jessica Hart, MD, MHQS Pediatricians have been forced to navigate diagnostic uncertainty, hospital closures, limited staffing, and new infection control guidelines. AMA J Ethics. 2023;25(2):E130-132. doi: 10.1001/amajethics.2023.130.
Policy Forum Sep 2022 Roles of Environmental Services Workers’ Wages and Status in Patient Safety David Sine, DBioethics and Lloyd Duplechan This article offers a risk management standpoint on environmental services as a mission-critical function of any health care organization. AMA J Ethics. 2022;24(9):E876-882. doi: 10.1001/amajethics.2022.876.
Policy Forum Jun 2006 Reputation, Gatekeeping, and the Politics of Post-Marketing Drug Regulation Daniel Carpenter, PhD Virtual Mentor. 2006;8(6):403-406. doi: 10.1001/virtualmentor.2006.8.6.pfor1-0606.
Policy Forum Oct 2004 The Universal Protocol Dennis S. O'Leary, MD Virtual Mentor. 2004;6(10):456-458. doi: 10.1001/virtualmentor.2004.6.10.pfor1-0410.