Foreign drug import is now legal: discussion thread

How lawyers are saying manufacturers will deal with this ruling:

  • Case Collard, partner at Dorsey and Whytney, believes that drug manufacturers will attempt to enforce the contracts they have with their distributors. Since drug companies deal with limited numbers of distributors, going after them is easier [than Lexmark going after many more retail customers]

  • Isaac Ashkenazi, partner at Paul Hastings, suggests that new distribution contracts may include clauses that require specific steps from the distributor to ensure clients will not export drugs back [into the US or other higher-tiered-pricing markets]

  • Nick Williamson, partner with Bryant Cave, believes that drug manufacturers may take over distribution where the danger of re-export is too high

  • Kevin Nelson, partner with Schiff Hardin, expects existing FDA regulations to be a significant barrier to import into the US. He explains that different versions of a drug [from overseas] may be treated differently by the FDA and require new approval.

Finally, the Biotechnology Innovation Organization (BIO), an industry trade group, had filed a friend-of-the-court brief favoring Lexmark, and its deputy general counsel, Hans Sauer, warns that some low-priced countries may see their access to critical drugs jeopardized by re-export into high-price markets.