Drugs

See Supply Chain Strategy as Core Regulatory Function: Attorney

Drug companies that operate in both the U.S. and the European Union (EU) should treat supply chain strategy as a core regulatory function and not an afterthought. That’s the key takeaway from attorney Winston Kirton (Baker Hostetler) in a recent Regulatory Horizons podcast on how regulatory practices in the U.S. and EU are reshaping life sciences manufacturing.

In the podcast, Kirton discusses changes at FDA, while the EU perspective is presented by Czech Republic attorney Tomáš Čihula.

Kirton says that in the last few years, life sciences companies have learned that the supply chain is no longer just an operating model; it is a regulatory position. He notes that FDA observers are seeing a heightened inspection focus on foreign manufacturing sites and more probing questions during application review about upstream suppliers. “Even at the legislative level,” he says, “there is an explicit concern about reliance on certain geographies.”

He adds that FDA is connecting supply chain transparency directly to post-marketing compliance, including field actions and enforcement discretion during shortages. “And what is striking,” he says, “is that neither system is explicitly banned in foreign manufacturing. Neither U.S. nor EU, but both seem to be clearly disincentivizing over-concentration in high-risk regions.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome