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MEDTECH Supreme Court Decision on ‘Compelled Speech’ Could Impact FDA’s Regulatory Authority
In a recent development that could have far-reaching implications, the US Supreme Court’s decision in the 303 Creative case has sparked a debate about the potential impact on the FDA’s ability to regulate statements from drug companies about potential risks posed by their products.
HCN Medical Memo
This development is significant, as it could potentially limit our access to comprehensive information about the drugs we prescribe. The FDA’s role in ensuring full disclosure of potential risks is crucial for informed decision-making in patient care. This shift could lead us to rely more on independent research and less on manufacturer-provided information, potentially changing the landscape of patient care and treatment.
Key Points
- The US Supreme Court upheld the right of a wedding website designer to refuse services for a same-sex marriage in the 303 Creative LLC v. Elenis case, citing it as a form of “compelled speech.”
- This decision could potentially affect the ability of physicians and patients to learn about the side effects of drugs.
- The First Amendment has been invoked to justify forbidding “compelled speech,” which could limit the FDA’s ability to regulate promotional statements made by drug companies.
- The case of lecanemab (Leqembi), a new monoclonal antibody for Alzheimer’s disease, serves as an example where manufacturers could argue against disclosing certain risks.
According to a study published in JAMA in 2016, only 46% of drug labels included information about the product’s use during pregnancy, despite the fact that nearly 90% of pregnant women take at least one medication.
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