Private plaintiffs have also challenged Orange Book patent listings in courts. Challenges to IRA Drug Pricing ProvisionsThe Inflation Reduction Act (IRA), enacted in 2022, contains several provisions aimed at lowering drug prices. 9 Kevin J. Hickey, Congressional Research Service, IF12644, Patent Listing in FDA’s Orange Book, at 2 (May 1, 2024), https://crsreports.congress.gov/product/pdf/IF/IF12644 . 10 Kevin C. Adam & Eugene Hutchinson, Five Drug Pricing Issues to Watch in 2023, White & Case Insight Alert (Dec. 20, 2022). 26 Greg Slabodkin, Stakeholders Hope Bill Will Create IRA Drug Negotiation Parity Between Biologics and Small Molecules, BioSpace (Feb. 29, 2024), https://www.biospace.com/article/stakeholders-hope-bill-will-create-ira-drug-negotiation-parity-between-biologics-and-small-molecules-/ .

Source: Forbes August 06, 2024 16:35 UTC