I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than a week after my post! But, for the first meeting of the new White House Council on Supply Chain Resilience, the administration announced plans to, among other things, use the Defense Production Act to have more essential medicines made within the United States. In fact, $35 million has been identified by HHS to invest in the domestic production of key starting materials in certain sterile injectables. In addition, HHS is designating a new Supply Chain Resilience and Shortage Coordinator to address shortages and work on methods to increase the resilience of the medical products supply chain. A new report is also being worked on by the Department of Defense to address reliance on pharmaceutical supply from “high-risk” countries.
Obviously, foreign suppliers of drug products and necessary ingredients play an important role in the U.S. pharmaceutical market, especially in the competitive generic drug industry. But at the same time, policymakers in the United States have become increasingly vocal about expanding domestic production of pharmaceuticals, especially during times of international shipping and supply disruptions.
Of course, these newly announced measures raise a host of other questions, and moving production to the United States is no easy task. Companies will certainly need to deal with FDA regulatory scrutiny of any new production sites. And, any manufacturing process of ingredients or finished product that is moved into the United States may raise additional patent concerns, particularly if certain intermediates in the production process that may be covered by U.S. patents now find their way into domestic production. The industry (and policymakers) will need to be mindful of these regulatory and patent issues as these efforts move forward.
“President Biden will issue a Presidential Determination to broaden the Department of Health and Human Services’ (HHS) authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed by the President as essential to the national defense.
www.whitehouse.gov/...
