IN CASE YOU MISSED IT… Chairman Rick Scott Highlights Key Testimonies from Hearing on America’s Dangerous Reliance on Foreign-Manufactured Generic Drugs

WASHINGTON, D.C. - In case you missed it, Chairman Rick Scott held a recent hearing of the U.S. Senate Special Committee on Aging sounding the alarm on the growing threats to the safety and reliability of foreign-manufactured generic drugs. The hearing: "Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to Aging Americans," examined how America's extreme reliance on foreign generic pharmaceutical manufacturing, particularly in Communist China and India, has exposed critical weaknesses in our drug supply chain.

Expert witnesses for the hearing included: Peter Baker, former Food and Drug Administration (FDA) Inspector and president of Live Oak Quality Assurance; George Ball, PhD, associate professor and Weimer Faculty Fellow at Indiana University's Kelley School of Business; and Brandon Daniels, chief executive officer of Exiger.

Watch the full hearing HERE or find key testimony expert below.

Chairman Scott began questioning whether the FDA has knowledge of manufacturing companies that continue to have problems and whether they hold companies accountable.

Chairman Scott: "You mentioned that the bad players list is no secret and these bad companies continue to avoid any significant consequences. That's telling me that the FDA knows which are the problem companies, but they aren't being inspected frequently enough or are still being allowed to import drugs Does the FDA have a list of bad companies? "

Mr. Baker: "Yeah, that list exists… I could just look into the database and see…"

Chairman Scott: "So they've got a list…and there's no consequences?"

Mr. Baker: "Very little consequences. When the FDA takes action, these companies just shift production to another facility in their network. It's a cat-and-mouse game… If you're caught breaking the law, as outlined in the regulations, you should be prevented from shipping products to the U.S."

Mr. Baker also emphasized the importance of unannounced inspections in catching violations that pose serious risks to patients: "Unannounced inspections have about a four-times greater chance of identifying a problem that's going to cause harm to a human… That's what the data shows. They're very effective. So, investment in that area is worth the effort."

Chairman Scott further highlighted the safety risks of foreign-made generics:

Chairman Scott: "Generic drugs manufactured in India have a 54% higher chance of an adverse event, including hospitalization, disability, and death, compared to similar drugs made in the U.S."

Dr. Ball: "That's correct."

Chairman Scott continued: "So let's say you're going to buy two cars, if you knew if you bought one of them…you had a 54% chance of something bad happening to you, what would you do?"

Dr. Ball: "…if I knew the difference, then I would spend the money to buy the higher quality product.."

Mr. Baker: "This testimony only addresses the tip of a massive iceberg. Fake laboratories pumping out hundreds of results a day that certified products as 100% pure when in fact the product was never tested. For those products that did get tested, any failing result was simply ignored and replaced by a fabricated passing value. We identified filthy registered shadow facilities that would funnel their drugs through modern and clean registered sites, which we refer to as the show facility. We found fabricated manufacturing and quality records, painting a picture of a site in total compliance when in fact substandard or fake medicines were being shipped to the US by the tens of thousands a day. Following these experiences, I have no doubt that adverse events, including death, happen on a daily basis here in the US as a result of substandard generic products from unregulated markets."

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"Shocking inspection reports continue to roll in on a monthly basis. The bad players list is no secret and they continue to avoid any significant consequences. Meanwhile, those most vulnerable in our society taking these drugs have no idea of the games being played and certainly no idea that the game as designed today can never be won. Personally, if I had a choice, I would never consume a drug product produced in an unregulated market. And any experienced FDA investigator will give you the same."

Chairman Scott raised questions about America's national security considering the nation's over-reliance on Communist China:

Chairman Scott: "Do we have our own source so that our military is never dependent on China?"

Mr. Daniels: "We do not…. It's kind of like what we have in critical minerals and magnets, where the commercial markets have so deeply been usurped by China that we don't have the investment capital coming in to offset it…we have to make those same kinds of investments in our pharmaceutical supply chains."

Chairman Scott: "Do you think it would be safe for our military to continue taking Chinese drugs?"

Mr. Daniels: "No, sir…the People's Liberation Army (PLA) is infused into the Chinese economy…several of the organizations that are producing these active pharmaceutical agreement ingredients, or KSMs, are actually sponsored and funded by PLA-funded entities or directly by the PLA…and make them essentially beholden to not only the Chinese Communist Party (CCP), but also the PLA."

Chairman Scott: "Would you say that the U.S. health care system is entirely beholden to the Communist Party of China?"

Mr. Daniels: "At the moment? Yes, sir."

Senator McCormick also questioned the lack of transparency around drug origins and the possibility of improving consumer insight.

Senator McCormick: "What level of transparency already exists for American health care consumers with regard to what country a medicine or its active pharmaceutical ingredients (APIs) are from and what improvements could be made to ensure Americans have better insight…of the origins of their medicines?"

Mr. Baker: "Transparency in the supply chain as far as what patients know about where their medications are made is virtually non-existent…It's a complicated issue because there are many players in the supply chain as outlined already, from the key starting materials all the way to the pharmacy and the finished drug. So, we would have to take a risk-based approach where the most critical step is, for example, if it's an aseptically filled product that's intended for injection, the step in the supply chain at which that product was aseptically filled in a sterile environment would be on the label. It's not a perfect solution, but it's the best we can do to help increase transparency and let the market fix the issues…"

Witnesses also commented on the terrifying reality of the impact of the nation's over-reliance on Communist China and India on our national security.

Chairman Scott: "Are there other drugs where we have such acute dependency on Communist China or another adversarial country?"

Mr. Daniels: "About 50% of our critical medicines fall into that category."

Chairman Scott: "So, do you think this is a national security risk?"

Mr. Daniels: "It 100% is."

Chairman Scott: "If China were to limit antibiotic-related APIs from being exported, would it impact us"

Mr. Daniels: "You'd see at least 50% of the antibiotics that your kids have access to evaporate… In fact, the next time one of your grandchildren gets a strep throat or an ear infection, I encourage you to look at it. I bet you dollars to donuts that it's made by Arabindo, which is an Indian manufacturer using Chinese KSMs and APIs."

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