Judge Rules FDA Can Review Data Not Referenced By 505(b)(2) Applicants, But Case Not Over

A federal judge, in a D.C. Circuit Court memorandum opinion unsealed last week, ruled that the Hatch-Waxman Act gives drug makers the right to choose which listed drugs they reference in 505(b)(2) applications but that FDA can look at data on similar drugs without requiring the applicants to reference relevant patents for those drugs. One industry attorney says U.S. District Court Judge Ketanji Brown Jackson's lengthy opinion is a well-reasoned "must read" for Hatch-Waxman practitioners and says the judge's opinion...