There s Simply Not Enough Transparency Ashley Moody Sounds The Alarm On Quality Control For Drugs

Thank you, Chairman Scott and Ranking Member Gillibrand for convening this hearing to examine what sounds like a very urgent need for transparency in our drug supply chain. Every day, millions of Americans rely on a wide range of medications to maintain their health and quality of life. As parents, we often take prescriptions to the pharmacy and get medications that we then tell our children to take, trusting that there are no quality control issues. So I think this should be top of mind for every American and certainly every parent. Unfortunately, throughout the hearings that we've had on this issue and this committee on drug supply transparency, it's become increasingly clear there's simply not enough transparency. And what's worse, FDA import alerts routinely cite carcinogenic impurities, falsified batch records, and non-sterile conditions from manufacturers in China and India. Roughly one third of all FDA import alerts target Chinese facilities, and another 16% target Indian producers. Just last year, I and many of my colleagues on this committee sent a letter to the FDA raising the alarm at problems with drug quality due to poor foreign inspections in countries like China and India, who together account for 60% of APIs globally. And that doesn't even include, as we've discussed already, the key starting materials. Many Americans who rely on prescription medications, particularly seniors, which is why this committee is paying such close attention, have no reasonable way to determine where their medications are manufactured, effectively denying them an opportunity to choose American-made drugs. And what we found is that this failure stems from a combination of loopholes and insufficient FDA enforcement, which allows foreign adversaries such as China to exert control over the production of drugs that Americans depend on to stay alive. It is crucial, and what I'm hearing from every witness today, that we take immediate action to increase transparency in our drug supply chain so that consumers can make informed decisions about the medications they use. Important, a study from 2022 found that 83% of top 100 generic drugs consumed by US citizens have no US-based source of active pharmaceutical ingredients. With that said, I would like to turn to one of the witnesses that I had to cut short when we were getting to time limits on introductions. Mr. Schondemeyer, in your testimony you wanted to further explain, I believe, about how in New Zealand they have a model for providing drug supply chain transparency, and that the New Zealand MedSafe program maintains updated information regarding active ingredients, which is available to the public. What aspects of that model would you say are most crucial to be included if the United States were to ever enact transparency measures on our drug supply chain? The New Zealand system takes their equivalent of FDA, and they collect all of the information we've talked about. Where are the key starting materials from, where are the inactive ingredients, where is the active ingredient made, and the factory name and address, the finished dosage form, manufacturer name and address, who packages the product, who labels it. Every step along the way is transparent, and for every prescription drug on the market in New Zealand, it's put in a database, and any consumer in New Zealand or the rest of the world can look up those products at the product-specific level and identify where did it come from. We should have nothing less than America. And in fact, if one looks at these days, the pharmaceutical supply system is really a global supply system. We talk about the US drug supply, but if we take that, that's probably 70% or 80% of the world's global supply. So it really is the same system. We need a system equivalent to, and we need to, I applaud FDA and the DailyMed website that's maintained, but it's not nearly as consumer-friendly as New Zealand's system is, and we need to look at, emulate their process, and then make transparent the information that FDA does have. Do you believe that the New Zealand model for transparency, the things that they have enacted, do you believe that has decreased the amount of contaminated drugs that are consumed by the public there? I believe it has, and I haven't seen studies from New Zealand about the number and types of shortages, but I think if they were at the same level as we see in the US, we would probably have seen studies of that type. I wouldn't draw a conclusion from it yet, but I don't think they have as severe a drug shortage problem as we do in the US for a variety of reasons. And I've talked with the officials at Medsafe in New Zealand, and they say they aren't aware of any commercial problems in the marketplace from making that information public. Thank you. Thank you, Mr. Chairman.