FDA Policy/General

FDA Should Consider Free Speech Decisions: MIWG

The Medical Information Working Group (MIWG) says FDA should include recent Supreme Court First Amendment free speech decisions in its ongoing analysis of manufacturer communications regarding unapproved uses of approved or cleared medical products. In a comment to the agency docket on the subject, MIWG says FDA should ensure that it incorporates the constitutional principles reflected in the decisions into its decision making processes for both policy and enforcement matters.

The letter references five cases and says that they:

clarify the line between protected speech and conduct;
clarify that rigorous scrutiny applies to any content-based regulation of non-commercial speech, and to any viewpoint-based regulation, including of commercial speech; and
reject any exception to the standards for speech in highly regulated areas, including medicine.

“Together, the cases demonstrate that FDA should continue to give serious consideration to First Amendment principles as it reexamines and clarifies its regulation of medical product manufacturer communications,” MIWG writes. “The cases also suggest that the agency should assure its analysis encompasses constitutional considerations beyond those identified in its 1/2017 Memorandum, including (1) the circumstances in which manufacturer speech comprises noncommercial, fully protected speech rather than commercial speech, and (2) whether FDA’s rules and policies would satisfy a strict scrutiny standard where applicable.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome