Pharmalittle: We're reading about an FDA panel nixing a Duchenne drug, FTC suing Hims & Hers, and more

The pharmaceutical sector faces new regulatory hurdles this week as federal agencies sharpen their focus on both drug approval processes and consumer protection. An FDA advisory panel recently voted 9-to-3 against the effectiveness data submitted by Capricor Therapeutics for its Duchenne muscular dystrophy treatment. Regulators highlighted significant changes to the study’s statistical plan, which undermined the clarity of the results and made it difficult to verify clinical benefits for patients suffering from Duchenne-related cardiomyopathy. This decision marks a major setback for the therapy after the agency previously sought additional evidence last year.

In a separate legal action, the Federal Trade Commission has filed a lawsuit against the digital health company Hims & Hers. The complaint alleges that the firm engaged in deceptive business practices regarding the handling of sensitive consumer health information. State authorities from Utah and California joined the federal agency in this action. The lawsuit claims that Hims & Hers misled users about how their data is shared with third parties and failed to provide clear disclosure when patients signed up for recurring subscription services.

Regulators also identified issues with the subscription model itself, specifically noting that the company makes it difficult for consumers to cancel services or review treatment recommendations from providers. This case is part of a broader trend of increased oversight directed at digital health platforms and their methods for obtaining medical histories and maintaining consumer consent. These developments reflect a shifting landscape for companies operating at the intersection of medical care and consumer technology.