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Where are U.S. drugs really made? A new Senate bill aims to find out

The vast majority of drugs that make it to American shelves are produced abroad, sometimes in countries that lawmakers worry don’t have the nation’s best interests at heart. But where are exactly are those drugs produced and how reliant is the U.S. on foreign imports? A new bipartisan Senate bill aims to find out.

Sponsored by Sens. Elizabeth Warren and Marco Rubio, the bill would require the Federal Trade Commission and Department of the Treasury to review where drugs used in the U.S. are made and the role that foreign manufacturing plays in the global supply chain, the legislators said in a joint release. 

That review has added importance during COVID-19 as countries lock down to control the virus’ spread and stockpile key meds in case of shortages or emergencies. Those factors combined have legislators worried that shipping drugs for U.S. patients might not be a top priority for other nations. 

“The coronavirus pandemic has made it painfully clear that we must take decisive action to rebuild our nation’s medical manufacturing sector,” Rubio said. “This bipartisan bill would ensure policymakers have the necessary information to address our supply chain vulnerabilities, the consequences of foreign investment in U.S. pharmaceuticals, and reduce our over-reliance on China for pharmaceuticals.”

The bill would require the FTC and Treasury to produce its report one year after it passes into law, according to the release. 

Rubio and Warren hooked up on another piece of legislation in March—the Strengthening America’s Supply Chain and National Security Act—that sought to reduce U.S. dependence on Chinese raw ingredients and active pharmaceutical ingredients (APIs). That bill is currently in committee assignment and has yet to face a vote. 

Rubio and Warren’s new bill is the latest escalation in Capitol Hill’s growing fight to bring drug manufacturing back stateside in light of the pandemic. 

So far, Big Pharma has shown little interest in legislators’ attempts at reform, saying that a wholesale change to supply chains would cause disruptions downstream for consumers—as well as affect companies’ bottom lines. 

The industry’s largest lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA), saw the bill as a positive step away from more punitive legislation. 

“We’re still reviewing the specifics of the legislation but appreciate that the senators recognize the importance of studying our supply chain rather than jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines,” a PhRMA spokesperson said in an email.

The full extent of U.S. dependence on foreign API and materials is little known. Warren and Rubio pegged the figure at 80% for the amount of API in U.S. drugs produced abroad. However, that number doesn’t tell the full story of the industry’s reliance on foreign-made meds.

Even PhRMA has admitted it doesn’t have a grasp on exactly where its members source their drug ingredients “because this information is generally considered proprietary,” a spokesperson previously said.

In an October 2019 hearing before the House Committee on Energy and Commerce, FDA Director Janet Woodcock said an estimated 28% of the API in U.S. drugs was produced stateside, a figure that has decreased in recent years.

“While there are many reasons for this shift, underlying factors that are often cited include the fact that most traditional drug production processes require a large factory site, often have environmental liabilities, and can utilize a low-cost labor force,” Woodcock said.

Chinese exports made up an estimated 13% of APIs used in U.S. drugs while India produced 18%, according to the FDA.

Legislators’ growing interest in “onshoring” foreign drug manufacturing has caught the eye of opportunistic investors. 

Last week, private equity firm Lincoln Equities Group said it was marketing a 433-acre, former Bristol Myers Squibb R&D and manufacturing campus in Hopewell, New Jersey, as a possible new home for an onshoring drugmaker.

Lincoln put the former Bristol site on the market with a specifically nationalist bent, angling for drugmakers that are part of the U.S. government’s efforts to build onshore production of pandemic-related drugs.

“Given the current public health crisis, we anticipate pharmaceutical and life sciences manufacturers to consider ‘reshoring’ and expanding operations in the U.S.,” Lincoln President Joel Bergstein said in a release.