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Washington, D.C. --- U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, gave the following opening statement this morning at a subcommittee hearing on the medical device and cosmetics provisions included in the Food and Drug Administration (FDA) Globalization discussion draft that he unveiled last month with U.S. Reps. John Dingell (D-MI), Chairman of the House Energy and Commerce Committee, and Bart Stupak (D-MI), Chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations.
"Good morning. Today the Subcommittee is meeting to review the medical device and cosmetic provisions of the Food and Drug Administration Globalization discussion draft. This is the third hearing on the draft that Chairman Dingell, Mr. Stupak, and I released a few weeks ago. Over the last few weeks, we discussed the food and drug-related provisions in the bill; today we will be focusing on the medical device and cosmetic provisions only.
"In recent years, there have been a number of incidents about medical device and cosmetic product safety that have endangered the lives of countless of Americans. In 2006, for example, 183,000 packages of contact lens solution, which is classified as a medical device, were recalled as a result of bacterial contamination. And this with a product that is classified as 'low risk.' This should not be happening.
"While Congress set out to address initial safety concerns with these and similar types of products under the Medical Device User Fee and Modernization Act (MDUFMA) reauthorization in 2007, it is clear to me that more most be done. The FDA is simply incapable of meeting the requirements of that legislation to inspect domestic and foreign device manufacturing establishments.
"In MDUFMA we added a two year inspection requirement for device manufacturing companies. However, according to GAO findings, the FDA inspects these establishments on average only every three years for high risk devices and every five years for medium risk devices. And I would be curious to know what the inspection frequency for low risk devices is.
"Perhaps even more disturbing are the inspection rates for international manufacturers of medical devices, which are estimated to be on average every six years for high risk devices and an incredible 27 years for medium risk devices. And while the market for these products becomes increasingly global, the FDA has no requirement to inspect foreign establishments manufacturing medical devices. Again, a clear gap in authority and it is up to us in Congress to act to allow the FDA to do its job and protect the American people.
"Of further concern is the FDA’s use of a risk-based classification system. While I understand that there are inherently more risks with a class III medically implanted device as with a class I contact lens solution, this classification is based only on the nature of the product and does not take into account information related to the actual manufacturers. This is especially concerning when the FDA appears unable to accurately report information on the number of medical device facilities both in the U.S. and internationally.
"Two databases exist at FDA to monitor and track inspections, and yet these systems cannot exchange information and are fraught with inaccuracies. One system reports that there are nearly 5,000 foreign establishments registered with the FDA for class II and III products while the other system reports that there were over 25,000 such establishments internationally. This difference is significant, and again illustrates the FDA’s inability to meet current and emerging regulatory responsibilities.
"These concerns were echoed in a 2007 report issued by the FDA Science Board that found disparities between the FDA’s responsibilities and available resources including: inadequate inspections of manufacturers; an obsolete technology infrastructure; an insufficient basis to access, integrate, and analyze data; and frequent system failures. These weaknesses jeopardize the FDA’s ability to fulfill its mission of protecting the American people, and must be addressed.
"Turning to cosmetics and personal care products, it seems to me basic logic for Congress to include this industry in our discussions today, as this industry is largely governed by legislation established back in 1938. Cosmetics and personal care products are used by Americans each and every day, and yet these billion dollar industries have gone largely unregulated.
"Under current federal law, the FDA cannot require companies to test cosmetic products for safety before marketing; they cannot review or approve cosmetic products before they are sold to the public; they cannot regulate cosmetic products until after they have reached the marketplace; they cannot require product recalls; and they cannot require manufacturers to register their cosmetic manufacturers, ingredient information, or report cosmetic-related injuries. Instead, the FDA has to rely on a voluntary reporting system that clearly lacks the means for a systemic examination of the safety of the cosmetic industry.
"Further, this voluntary system has been used as rationale against calls for reform in this industry. FDA estimates that over the three decades during which the voluntary Cosmetic Industry Review (CIR) process has been in existence, only 11 percent of the ingredients used in cosmetic products have been reviewed.
"In addition, countries in the EU have actually banned the use of certain ingredients in cosmetic products yet there are no restrictions in place in the U.S. And some studies suggest that there are a vast number of products on the market that contain prohibited chemicals that have been deemed unsafe for use by the industry’s own Cosmetic Industry Review process. This, to me, is overwhelming evidence that the FDA must be empowered with the authority to regulate this industry to protect the public.
"I want to thank all of the witnesses for appearing here today and I look forward to a good discussion on all of these issues. I now recognize my colleague from Georgia, Mr. Deal, for five minutes for his opening statement."
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