Nearly 600 FDA Postmarket Drug Studies Are Behind Schedule While Many of the Medicines Stay on the Market
A KFF Health News analysis found nearly 600 postmarket drug studies delayed, involving 350 products. Many remain on the market without completed safety or effectiveness research. Amgen's Tavneos and Sarepta's Exondys 51 are among the delayed studies. HHS notes delays don't necessarily indicate safety issues but require case-specific review.
How this was made
The 30-second read
Why it matters
Regulatory compliance risk remains elevated for drugs with pending studies, but no immediate enforcement actions are detailed.
Market read
The piece underscores compliance risk for biotech firms but offers no new catalyst for immediate trading.
What to watch
Potential for FDA to prioritize high‑impact drugs could mitigate risk for smaller studies.
Background
The article reviews FDA data showing nearly 600 post‑market studies are delayed, affecting about 350 products.
Ticker impact
Amgen's vasculitis drug Tavneos has a delayed safety study and faces possible FDA withdrawal.
downside risk if FDA moves to withdraw approval
FDA scrutiny and pending withdrawal proceedings create uncertainty for the drug's revenue.
Pfizer's COVID‑19 treatment Paxlovid study in pregnant women missed its reporting deadline.
limited impact unless FDA takes action
The study delay is noted but does not yet affect product availability.
Sarepta Therapeutics' Duchenne drug Exondys 51 has a delayed final report, with data expected later this year.
potential upside if data are positive, downside if negative
Investors will watch the late‑year data for guidance on the drug's efficacy.
Market effects
Highlights broader concerns about FDA post‑market study compliance across pharma.
U.S. biotech sector may see modest scrutiny, no immediate regional shift.
Limited to companies with accelerated‑approval drugs; no global macro effect.
Counterpoint
Delays are common and may not materially affect long‑term drug profitability.
Key entities
- companyAmgen
Manufacturer of Tavneos, facing FDA scrutiny.
- companyPfizer
Manufacturer of Paxlovid, study delay noted.
- companySarepta Therapeutics
Manufacturer of Exondys 51, awaiting data release.
