Vanda Pharmaceuticals, Inc. v. Food and Drug Administration Brigid DeCoursey Bondoc & Keunbong Do* I. Why It Made the List The Freedom of Information Act (FOIA) has allowed public to access government-held information upon request, while providing exemptions to protect certain information from disclosure. Over time, however, concerns that some agencies are overusing these [...]

United States v. California Stem Cell Treatment Center Anne K. Walsh* I. Why It Made the List Any case that FDA loses is significant. But this case is extra special because it tees up a potential circuit split that could jeopardize FDA’s regulatory authority over regenerative medicines. FDA has appealed this decision, so next [...]

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC Sara W. Koblitz* I. Why This Case Made the List Patents listed in FDA’s List of Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) play a critical role in maintaining the balance between access and innovation that underscores the Drug Price Competition and Patent [...]

(Alleged) False Statements to FDA Do Not Necessarily a False Claim Make Lynn C. Tyler* In connection with an FDA pre-approval inspection of a pharmaceutical manufacturing facility, a company makes false statements and provides false records to FDA inspectors. The company passes the inspection, which allows it to manufacture and sell the product, including [...]