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# Return Drug Manufacturing to U.S.: Hahn, Shah
- URL: https://www.fdaweb.com/return-drug-manufacturing-to-u-s-hahn-shah/
- Published: 2020-09-10T12:00:00.000Z
- Updated: 2026-09-14T16:28:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147630

FDA commissioner **Stephen Hahn** and deputy commissioner for medical and scientific affairs **Anand Shah** say that action to bring America’s critical medical supply chain onshore and modernize infrastructure for life sciences manufacturing is long overdue. “Even prior to the pandemic, our supply chain was under pressure,” they [write](https://www.cnbc.com/2020/09/10/op-ed-the-coronavirus-pandemic-underscores-the-need-to-bring-drug-manufacturing-back-to-us.html?ref=fdaweb.com) in an online CNBC opinion column.

The two say that FDA has been highlighting the issue for years. The agency, they say, has learned that the problem has two sides.

First, their column says, companies have incentives to outsource medical manufacturing to countries such as China and India where the cost of both labor and manufacturing is lower than in the U.S. And second, the adoption of new manufacturing technologies has been slow, with many companies still relying on the same 50-year-old processes for producing their products.

Hahn and Shah outline the steps the agency has taken, including the creation of the Office of Pharmaceutical Quality, quadrupled inspections of foreign drug manufacturers, and the creation of an emerging technology team.

“FDA can’t do it alone,” they write. “We need enduring solutions that address the root causes of America’s medical manufacturing crisis.” They call for: 

- better data to untangle supply chain knots, including the creation of a quality rating system and a systematic study of the contracting practices that may contribute to drug shortages;
- efforts to incentivize manufacturers to return home; and
- sufficient investments in medical manufacturing that focus on new technologies from continuous manufacturing of pharmaceuticals to additive manufacturing of medical devices.

“Covid-19 is an overdue reminder for medical manufacturing to return to the United States,” Hahn and Shah conclude. “For years, FDA has been working to pave the regulatory road home. We now need investments and the creation of incentives to grease the wheels for innovation, and commitments from industry to again give our health system the choice to ‘Buy American’ when it comes to medical products.”