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Supercharging a New FDA: Marty Makary on Science, Power & Patients

Thu, 15 Jan 2026 19:35:00 +0000

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Marty Makary Right 01:02:24 healthgovernment

The FDA's biosimilar approval reforms will cut the typical biosimilar approval timeline from 5-8 years down to about 2.5 years, saving over $100 million per drug.

“shortening the time frame from 5 to 8 years to 2 and 1/2 years or more” View on YouTube
Explanation

In October 2025 the FDA under Makary announced it would eliminate onerous clinical-trial requirements for biosimilars, cutting roughly $200 million and years off development time, matching the predicted timeline reduction from 5-8 years toward roughly 2.5 years.

Marty Makary Right 01:00:28 healtheconomygovernment

Under the FDA's most-favored-nation pricing push, GLP-1 drug prices will drop to $149 for the first three months of treatment.

“it's going to come down to $149 for the first three months” View on YouTube
Explanation

Multiple GLP-1 products reached the $149/month price point in 2026, including Eli Lilly's oral Foundayo and Novo Nordisk's oral Wegovy pill through NovoCare, matching the predicted price target.

Marty Makary Partly Right 01:07:09 healthgovernment

In 2026, the FDA will move a significant number of additional drugs from prescription to over-the-counter nonprescription status.

“My one of my big 2026 goals is that we want to see more drugs move to nonprescription” View on YouTube
Explanation

Makary publicly pushed for a 'mass transition to more nonprescription drugs' in early 2026 and the FDA published new Rx-to-OTC switch guidance, but a large-scale shift of drugs to OTC status hadn't materialized by the time Makary resigned as FDA Commissioner in May 2026.

Marty Makary Right attribution: medium 00:11:06 healthgovernmentai

Using AI, the FDA will reduce its drug application completeness-check response time down to one day.

“We're going to get that down to one day” View on YouTube
Explanation

Under Makary, the FDA deployed an AI tool that replaced its traditional 60-day completeness-check filing process with a review taking minutes, exceeding the one-day target described.