Subcommittee on Health Holds Hearing on Over-the-Counter Monograph Drugs
WASHINGTON, D.C. – Yesterday, Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, led a hearing titled Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs . “Over-the-counter (OTC) medications help Americans live longer, healthier, and more comfortable lives. This hearing was critical to understanding the vital role that safe, reliable, and affordable OTC medications play in our nation’s overall health,” said Chairman Carter. “I look forward to working in a bipartisan manner to reauthorize the Over-the-Counter Monograph Drug User Fee Program so that we can continue to support FDA’s work to bring pharmaceutical manufacturing back to America and increase patient access to OTC medications.” Watch the full hearing here . Below are key excerpts from yesterday’s hearing : Congressman John Joyce (PA-13): “The United States is home to world leading medical innovation. In fact, I often talk about innovation being the cornerstone of American medicine, being the cornerstone of how I practice medicine. Unfortunately, the FDA’s inaction has prevented this innovation, allowing the rest of the world to access new active sunscreen ingredients that are unavailable to Americans. Can you expand upon some of the barriers that are hindering the great innovation by not utilizing the information that our friends and allies have access to?” Mr. D’Ruiz: “People don’t die from using sunscreen. They die from not using sunscreen, number one. And I think there is a large body of evidence worldwide indicating that the news of young sunscreen filters, which have been developed over the last 10 years, are much more efficient – you use less, there is less exposure, and they are much more effective in reducing the harmful effects of both UVA and B. And three, they are more sustainable in terms of environmental impact.” Congresswoman Kat Cammack (FL-13): “You have companies that are already doing things the right way. We don’t want to punish them by putting additional burdens on them to try to capture those companies that are not in compliance. How can we handle that?” Mr. Menzel: “I think that it’s an incredibly important point that we don’t need more regulation as it relates to this, so there needs to be predictability. The OMUFA program allows predictability. The monograph program allows predictability, allows for innovation, allows for speed.” Congressman Bob Latta (OH-05): “The Over-the-Counter Monograph Drug User Fee Program (OMUFA) at the Food and Drug Administration has produced more than 100,000 safe and effective over-the-counter drugs, giving consumers access to manage their own care in a safe and affordable manner. The OMUFA program has also reduced the number of visits consumers need to make to a doctor to obtain a prescription for a simple treatment, reducing the burden on our health care systems. The OMUFA program has also increased access and choice for consumers. Could you provide examples of how this is beneficial to the public within the United States?” Mr. Menzel: “Yeah , absolutely, I think, in terms of the benefit to the US consumer, one of the items that I think continually needs to be reinforced is for every $1 spent in this space on over-the-counter medicines, it saves the United States health care system $7 in terms of doctor visit cost savings. Pharmaceutical alternatives to pharmaceutical cost savings, the other thing that system does is it allows for a shrinking of these healthcare deserts, where access would be limited, not just in rural areas, but also urban areas that are limited by access to health care.” ###