INVESTIGATING GENERICS: Senate Probes Drug Manufacturing Failures and Risks to U.S. Supply

On Sept 17, 2025, the Senate Committee on Aging held a bipartisan hearing to discuss issues with drug manufacturing that put Americans — especially older Americans who may be prescribed multiple medications — at serious risk.

Senators Kirsten Gillibrand (D-NY) and Rick Scott (R-FL) led the meeting, which featured testimony from Peter Baker — a former FDA inspector who has participated in MedShadow’s webinars on this topic — as well as George Ball, Ph.D., a professor at Indiana University specializing in pharmaceutical supply chains; Brandon Daniels, CEO of Exiger, a supply chain analytics firm; and Ronald Piervincenzi, PhD, CEO of the U.S. Pharmacopeia.

One of the most striking moments came after Peter Baker detailed the challenges of inspecting overseas laboratories, including cases where companies created fake labs solely to mislead inspectors. From there, he turned to a personal scene with his grandmother, grounding the issue in reality:

“When my 91-year-old grandma was alive, we would go pharmacy-hopping around our rural Oregon hometown in the hopes of finding a batch [of medication] that was made by a reliable producer. Sometimes we succeeded, and sometimes not. I remember one time having to settle for a product manufactured by Ranbaxy, who had just settled with the DOJ for 500 million for faking countless data points used to demonstrate their products were safe. I tried to stay positive because causing her panic wasn’t going to help, but inside, I felt sick, and I was not the one receiving cancer treatment.”

Following Baker’s testimony, Dr. George Ball explained that the generic drug marketplace is structured to reward manufacturers for driving down costs, often at the expense of safety and quality. Dr. Ball told the committee that greater transparency is needed around both medication quality and manufacturing locations, which often span multiple facilities and countries, noting that such information is surprisingly difficult to track for individual drugs.

Third on the agenda, Brandon Daniels presented his company’s report outlining serious risks in the pharmaceutical supply chain. He pointed out that three-quarters of drugs designated as essential medicines are sourced overseas. China, for example, manufactures the key ingredients in 90% of antibiotics. If China decided to stop supplying medications to the U.S., Daniels noted, it would be devastating. Moreover, China and India, which are together responsible for the majority of generic drugs sent to the U.S., are frequently subject to import bans due to failed inspections and low-quality drugs.

Lastly, Dr. Piervincenzi described the drug manufacturing process as a complex, multi-step system involving numerous facilities; one that leaves little room for transparency or consistent quality control. According to Dr. Piervincenzi, only 12% of the active pharmaceutical ingredients (APIs) analyzed by his team originated from the U.S. Additionally, despite thorough analysis, the origins of key starting materials — chemicals used to produce active ingredients — remained unclear, highlighting the opacity of the drug manufacturing process.

Dr. Piervincenzi called on the senators to develop a Drug Supply Chain Resilience Initiative (DSCRI) that would judge manufacturers based on the stability they bring to the supply chain as well as the consistent quality of the medications they produce.

Even before the September 17th hearing, strategies have been proposed to improve the quality and reliability of medications, but it remains unclear what actions the government will ultimately take.

MedShadow has been consistently investigating the issue of low-quality generic medications. Our coverage has included the FDA’s backlog of overseas laboratory inspections, a pharmaceutical company caught falsifying data on hundreds of drugs, and the wide disparities in efficacy among generic ADHD medications, among other stories. We are also producing webinars with whistleblowers and industry experts that examine how the flaws in the generic drug supply chain can be addressed.

MedShadow will continue to follow this issue closely and cover future Senate hearings as they arise.