Trade Pact War: Generic Stakeholders Push For Changes To US-Mexico-Canada Deal, Seek FDA Intervention

The Association for Accessible Medicines and other groups are urging the federal government to make changes to the text of the United States-Mexico-Canada Agreement (USMCA) to make it consistent with US law and ensure that it does not benefit innovator biopharma companies over generic and biosimilar makers.

The AAM is asking the US Trade Representative to add provisions to the trade pact that would establish a formal system, like the 180-day exclusivity period for generics, to incentivize generic manufacturers to challenge patents; require a public registry for all patents and exclusivities granted to a drug; strengthen the so-called "Bolar" exception allowing generic manufacturers to