On July 9, 2021, President Joe Biden signed an Executive Order
that the Administration stated would promote competition in the American economy. The broad scope of the Executive Order includes a number of initiatives focusing on healthcare, including pharmaceuticals. Interestingly, changes announced in the Executive Order were originally proposed by the Trump Administration, as discussed in our prior Updates, here
, and here
. Initiatives include calls to combat “excessive pricing,” to enhance domestic pharmaceutical supply chains, to reduce the cost of drugs to the Federal government, and to address “price gouging”; additional actions to support the implementation of Canadian drug importation and to promote low-cost generics and biosimilars. A number of the proposals may be inconsistent with existing statutory and regulatory authority, with litigation likely to follow if these proposals are finalized and implemented.