FDA Rejects Replimune Drug, Probes Telehealth Fees
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- FDA rejected Replimune’s advanced skin‑cancer drug after the agency said a single‑arm study without a control group was insufficient, demanding data from a well‑controlled trial.
- Robert F. Kennedy Jr. told a Senate hearing he had no role in the FDA’s decision, attributing the outcome to FDA Commissioner Marty Makary and a unanimous panel vote against the drug.
- STAT reports that telehealth platforms receive large annual fees from drugmakers and offer drug‑specific coupons, prompting health‑policy experts to warn they may breach federal anti‑kickback laws and spur overprescribing of costly branded meds.
Why it matters: Not enough in the article to say why this matters.
