Drugs and devices already on the market await FDA-ordered studies
The FDA often approves drugs with postmarket safety studies, but many are delayed. Tavneos, a drug by Amgen, is one example with delays and reported liver damage cases. KFF Health News found hundreds of delayed studies, raising concerns about patient safety and wasted resources. The FDA defends its approach, citing legitimate reasons for delays. Companies like Pfizer and Amgen are working to complete their studies. The delays can leave patients and doctors uncertain about risks and benefits.
How this was made
The 30-second read
Why it matters
The disclosed delays raise safety and liability concerns, possibly influencing investor sentiment toward the affected firms.
Market read
While the article provides new data on study delays, the material impact on individual stocks is likely modest.
What to watch
Potential for regulatory reforms that could tighten post‑market study enforcement, affecting future approvals.
Background
The article reviews FDA‑mandated post‑market study delays across several drugs and devices, citing specific companies and FDA letters.
Ticker impact
Amgen is the maker of Tavneos, whose FDA‑mandated post‑market safety study is severely delayed.
likely pressure as investors price in safety‑study delays.
Delayed study could trigger regulatory scrutiny or affect future sales.
Pfizer is cited for the delayed post‑market study of Paxlovid in pregnant women.
possible modest downside as safety concerns linger.
The study delay is one of many FDA follow‑ups; impact likely limited.
Enovis is mentioned as the marketer of the STAR Ankle device with a delayed post‑market study.
minor pressure if investors focus on product risk.
The device is a small portion of Enovis' portfolio.
Stryker is referenced regarding the Scandinavian Total Ankle Replacement system with a lagging study.
slight downside risk.
Impact is limited to a niche orthopedic product.
Market effects
Highlights systemic delays in FDA post‑market studies, potentially prompting broader scrutiny of drug and device pipelines.
U.S. healthcare and biotech stocks may see modest caution.
Limited to markets with exposure to the named companies.
Counterpoint
Delays may be administrative; underlying products could still perform well if safety is later confirmed.
Key entities
- CompanyAmgen
Manufacturer of Tavneos, a rare‑disease drug.
- CompanyPfizer
Maker of Paxlovid and Oxaydo.
- CompanyEnovis
Markets the STAR Ankle device.
- CompanyStryker
Former seller of the Scandinavian Total Ankle system.
