System needs to be changed to enable US FDA to share COVID-19 application data and inspection reports with other regulatory authorities, stakeholders urge. Merck’s Julie Gerberding and former FDA Commissioner Hamburg criticize company announcement of data via press release prior to submission.

Federal government needs to make sure its messaging on vaccines is harmonized, CBER director Marks says. Vaccine development could have been accelerated in pregnant, pediatric and immunocompromised populations, he notes.

In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.

Bills to reign in petitions, pay-for-delay, product hopping, and patent thickets clear House Judiciary Committee. Legislation may have better shot at enactment this time around given bipartisan support in both House and Senate Committees.

In response to industry input, the agency made a few changes to its draft guidance but several issues remain uncertain, such as what constitutes ‘minor differences’ between gene therapy products.

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.