STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
Why it matters: The FDA's proposals could shift drug manufacturing and early-stage trials to the U.S., impacting generic drug competition.
- The U.S. Food and Drug Administration (FDA) proposes policies to encourage domestic drug development and manufacturing, aiming to counter China's dominance in early-stage clinical trials (STAT).
- FDA Commissioner Marty Makary advocates for "giant, big ideas" to make it easier to run early-stage trials in the U.S. and give U.S.-based generics manufacturers an advantage (STAT).
- A legislative proposal in the FDA’s budget justification would allow domestic generic drug manufacturers to challenge brand drug patents a month before foreign companies (STAT).
- AbbVie and Genentech will sell medicines on the TrumpRx website, with AbbVie offering Humira at an 86% discount (CBS News).
- The TrumpRx website now sells over 61 drugs at lower prices, up from about 40 in February, though discounts are only for uninsured patients or those whose insurance doesn't cover the full list price (CBS News).
The FDA is proposing "giant, big ideas" to incentivize domestic drug development and manufacturing, including policies that would give U.S.-based generics manufacturers a competitive edge, as the Trump administration continues efforts to bring drug production back to the U.S. Concurrently, AbbVie and Genentech have joined the TrumpRx website, offering significant discounts on medicines like Humira for uninsured patients, expanding the site's catalog to over 61 discounted drugs.
