Trade Pact War: Generic Stakeholders Push For Changes To US-Mexico-Canada Deal, Seek FDA Intervention
AAM wants Orange Book-like registry of patents and exclusivities, Bolar and "best mode" provisions; consulting group urges FDA to step in and ensure the trade pact does not benefit originators over generic/biosimilar makers.
You may also be interested in...
US-Mexico-Canada Trade Agreement Sets 10-Year Floor For Biologics Market Exclusivity
USA's 12-year-plus scheme won't change, but Canada and Mexico must offer sponsors more than previously; biosimilar industry bemoans lack of incentives for competition. Trade pact also specifies damages award options and links regulatory review to patent disputes.
FDA Commissioner’s Rx For US Biosimilars Market: Reform Contracting Practices And Payment Models
In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake.
What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?
Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.