HR 3 has been re-introduced, and some provisions may be attached to the White House’s infrastructure bill, but the government price negotiation system envisioned by the bill may fail – if industry can convince Congress to focus on access to medicines, not their cost.

High court’s decision that FTC lacks authority to seek monetary recovery in litigation is boon for drug makers who have been subject to hefty payouts in reverse settlement and other cases brought by the commission.

Planned 31 May revocation of enforcement discretion for certain cell therapy products without IND or BLA is important, but experts say the FDA’s next moves are what will really shape the field and patient safety moving forward.