The WSJ editorial board documents the growing rift between practicing oncologists and the FDA's current approach to accelerated-approval oncology drugs — and the role HHS Secretary RFK Jr.'s team is playing in tightening the screws.
The case in point: an approved immunotherapy that practicing oncologists describe as “transformative” but that the FDA review team has said “looked at that drug said it was not effective.” Dr. Pavlick, interviewed in the piece, calls the assessment “ludicrous.” Her phrase: “These are not opinions. These are patients.”
The Bigger Problem
Accelerated approval pathways exist because Phase III trials for rare cancers cannot recruit enough patients to hit traditional statistical power. The FDA's current leadership, the board argues, is treating the shortcut as an abuse instead of as the mechanism Congress designed.
What's At Stake
If RFK Jr.'s team narrows the accelerated pathway, the cost is not a quarterly earnings beat. The cost is measured in patients who will not receive therapies that work.
What This Means For Our Portfolios
- Healthcare Innovation 4% — conviction holds. LLY, VRTX, REGN, ISRG. The best-in-class names have pipelines that survive a tighter approval regime.
- Watch accelerated-approval-dependent names. Small-cap oncology (MRTX, RLAY, RCKT) has outsized exposure. Position sizes small; reassess after June advisory committee calendar.
- UNH Q1 beat today (+5%) is the set-up. If treatment access narrows, payors gain margin. Awkward but true.
- For client conversations: this is the pairing column to Baggini's Véliz review. Both pieces ask: who decides who gets treated?