new drugs approved since 2020. within 60 days.

The human cost

• Patients: the number of people in the US who become eligible for the drug each year, times the wait beyond 60 days, in years.
• Years of life: those patients, times the extra time patients lived in the drug's randomised trial (median survival with the drug minus median survival without it).
• Every eligible patient is counted. Not all of them would have taken the drug, and the median gain stands in for the average. Each drug's row shows its numbers and where they come from.
• Only cancer drugs with a randomised trial that measured survival are counted so far.

The clock

• It starts the day the FDA received the application and stops the day the drug was approved. Both dates are the FDA's own.
• It never pauses. Where the FDA rejected an application before approving it later, that time counts, and the drug is labelled "Rejected first". The FDA has not published every rejection letter, so some long waits carry no label.
• The wait the human cost counts is the days at the FDA minus 60.

The benchmark

• Every drug is measured against a 60-day review. The FDA's national priority voucher programme targets a review of one to two months after final submission, against the usual 10 to 12.
• If that can be the target for those drugs, the deadline for the rest is a choice.
• No drug here was approved within 60 days. The fastest took .

What is not here yet

• The human cost of the other drugs. Most were never tested for how much longer patients live, so their cost is harder to count. It is not zero.
• Drugs still waiting for a decision today.
• Vaccines, gene therapies and blood products, which a different FDA centre reviews.

Sources

• FDA compilation of new drug and biologic approvals: filing dates, approval dates, designations.
• openFDA complete response letters: rejection letters the FDA has published.
• All records are in data/drugs.json, and the human cost inputs in data/human_cost.json.