Changing FDA Approval Standards: Ethical Implications for Patient Consent

Changing FDA Approval Standards: Ethical Implications for Patient Consent
Jonathan J. Darrow, Sanket S. Dhruva, Rita F. Redberg
Journal of General Internal Medicine, 8 April 2021
Open Access
The pace of new drug and medical device introductions has accelerated in recent years. In 2018, 59 novel drugs were approved in the USA, the most since 1996. A rising proportion of drugs and devices qualify for one of the US Food and Drug Administration’s (FDA) expedited programs, which allow approval based on less rigorous clinical trials. Expanded access and emergency use authorization allow access to products—such as remdesivir (Veklury) and COVID-19 vaccines—even before they are approved.

The growing array of products made available with limited evidence poses important challenges for patients and physicians. Ethical principles require that patients consent to treatment after being informed of the benefits and harms of each alternative. In routine practice, however, the consent process is often truncated, with limited presentation of alternatives, risks, and outcome data. As regulatory processes have evolved, the consent process—already criticized by some as inadequate—has changed little. We review the evolution of drug and device evidence requirements and consider the implications for informed consent…

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