FDA Official Laments To Congress That Drug Recall Decisions Rely On Foreign Labs

FDA Official Laments To Congress That Drug Recall Decisions Rely On Foreign Labs

When drugs are pulled from pharmacy shelves, it’s somewhat of a well-kept secret that it is the pharmaceutical company that voluntarily warns buyers of the potential harm from the defect. The Food & Drug Administration (FDA), and Americans who take prescription drugs daily, are reliant on the good graces of labs, most of them foreign seeing how over 80% of America’s generic drugs are not made domestically.

“I don’t understand how mandatory recall is not one of your tools,” Rep. Frank Pallone (D-NJ-6) said to Patrizia Cavazzoni, a doctor and the director of the FDA’s Center for Drug Evaluation and Research in a House Health Subcommittee hearing on Wednesday.

Pallone gave a now infamous example from last November when contaminated eye drops made in India resulted in vision loss, and in one case — death.  He asked if the FDA should be involved in these recalls instead of the labs themselves.

But Cavazzoni said that’s not in the FDA’s purview.  “Mandatory recall is an authority that we don’t have for drugs. It would be incredibly important to have to protect the public. The example that you gave is a very egregious example where we had a bad actor who introduced contaminated eye drops into the United States. Those eye drops caused horrible problems for patients. But we cannot require a manufacturer to recall the drug promptly. And in this particular situation, it actually took quite a bit of time while all of this harm was happening among the public.”

Despite relying on foreign labs voluntarily pulling a product from the market, the FDA is often at odds with its mandate of maintaining drug safety and supply. Unless the drug is deemed too harmful for public consumption, the FDA will almost always allow for imported drugs from labs that had recent recalls or received poor remarks from FDA inspectors on lab visits.  Drug shortages were a big part of Wednesday’s hearing, with Subcommittee Ranking Member Anna Eshoo (D-CA-16) lambasting the FDA witnesses.

“Drug shortages have for decades threatened adequate delivery of quality patient care and severely limited Americans access to life-saving drugs. Drug shortages are caused by long-term structural factors, including our over-reliance on foreign sources for essential medicines and active pharmaceutical ingredients,” Eshoo said, adding that she has addressed this issue with senior FDA officials before. Her bill, the Drug Origin Transparency Act, is designed to provide the FDA with the information they have repeatedly said they need to identify where drugs and APIs are made in order to prevent shortages. It’s still sitting in committee.

“Almost a year later, we have not advanced legislation to address these drug shortages. The stories are here from patients and physicians, especially those treating children, have not stopped coming. In an April 2024 survey by the American Society of Health System, pharmacists found shortages of critical drugs reached another record high this year, with more than 323 drugs in shortage,” Eshoo said.

Pallone chimed in. “It’s unacceptable that the agency still does not have the ability to recall unsafe, adulterated or otherwise dangerous products and is instead forced to rely on the goodwill and voluntary compliance of manufacturers. I’m concerned that Congress has not taken action to combat drug shortage issues before they continue to worsen.”

Cavazzoni was under pressure all morning from members on the committee.

Rep. Cathy Rodgers (R-WA-5): “A number of members on this committee have expressed interest in getting necessary medical supply chains out of adversarial nations and into nearer and friendlier to the United States. And we often hear the FDA is not a partner and can be an impediment. And I’d like to change that.”

Cavazzoni: “We are also very concerned about the lack of redundancy, resilience, and lack of geographic diversity in the supply chain. And we remain very interested in working with Congress to address those issues.”

Cavazzoni was joined by Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health.  While much of the long two-hour hearing centered on fast-tracking drug discoveries under the accelerated approval scheme, supply chain transparency, and artificial intelligence, members from both parties showed interest in shortages. The takeaway was that the FDA wanted to do something about it, and was on the same page as far as their concerns go, but a lot more could be done to remedy the situation.

Rep. Kathy Castor (D-FL-14) mentioned medical equipment shortages and FDAs work in this space. “I know during the pandemic you had the authority to require medical device manufacturers to submit information related to the shortages, and that by the end of 2022, the agency had received over 455 potential and actual shortage signals. So you would like this authority so we can tackle medical device shortages, too, is that right?”

Shuren said the FDA wanted that authority, suggesting information on device shortages once supplied during the pandemic years is no longer being provided to them post-pandemic.

“We’re dealing with medical device shortages all the time,” FDA director Shuren told the Committee on Wednesday. “But now we have essentially gone dark in some respects because we are not getting those notifications about shortages anymore. We have that authority for drugs, but we don’t have it for devices.”

“We also need help from Congress on authorities to prevent device shortages. We heard a lot about drugs, but we need help on devices because they’re happening every day and we don’t have all the tools we need to prevent that,” Shuren said.

In early May, the FDA sent a Warning Letter to a Chinese manufacturer of syringes. The Veterans Administration then banned those devices from its hospitals. See CPA’s report on this dated May 1.

Still, some members of this Committee think reliance on China and India for generics and low-value medical devices can be easily remedied by shifting supply chains elsewhere. No one spoke about bringing that production home during the hearing.

Rep. Diana Harshbarger represents Tennessee’s first Congressional district. In that district is a town called Bristol. That town is home to USAntiobitics, the nation’s only producer of amoxicillin, which was in short supply in 2022 and 2023. The powdered form of amoxicillin is still in short supply, according to the FDA.  But Harshbarger spoke about friend-shoring instead.

“In February of this year, Chair Rodgers, Democratic Rep. Juan Vargas of California, and I had a very positive meeting with FDA Commissioner (Robert) Califf, where we discussed our shared goal of reducing our reliance on China and protecting and fortifying our medical supply chains through a friend shoring or nearshoring strategy,” she said, saying their focus was to build labs and source from labs in the Middle East.

Most of American generic drug recalls stem from foreign labs. Foreign labs are not inspected by the FDA as regularly as U.S.-based labs, where the FDA can drop in unannounced.  That is not the case overseas.

“One of the challenges we face is that we will decide that there are standards as to what would constitute a recall and companies have to follow those standards,” Shuren said. “But we are dependent today on them identifying the problem and then reporting it to us. And I think you’ve seen some fairly high-profile instances where a company had recalls and they did not tell us about it.”


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