Statements on Introduced Bills and Joint Resolutions

Floor Speech

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - July 31, 2008)

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Mr. GRASSLEY. Mr. President, as Ranking Member of the Senate Finance Committee, I view my role as working to ensure the safety and well-being of the more than 80 million Americans who are beneficiaries of the Medicare and Medicaid programs. These programs spend a lot of taxpayers' money on prescription drugs and medical devices, and that money should be spent on drugs and devices that are safe and effective.

Over the last four years I have conducted extensive oversight of the Food and Drug Administration. I have reviewed and questioned how the FDA handles the pre-market review and post-market surveillance of drugs, biologics, devices and veterinary medicines to assess whether or not the agency is fulfilling its mission to protect the public health. As a result of my oversight activities, I identified serious problems at the FDA that included the quashing of scientific opinion within the agency, delays in informing the public of emerging safety problems, too cozy a relationship between the FDA and the industries it is supposed to regulate, and a failure to be adequately transparent and accountable to the public.

Last year, when the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee were working on FDA legislation, I encouraged them to take that opportunity to reform, improve, and re-establish the FDA as the gold standard for drug safety. I believed the FDA needed additional tools, resources, and authorities to do its work.

The Congress passed the Food and Drug Administration Amendments Act last September. While we did not fix a fundamental problem at the FDA that's been shown through my investigations over the last few years, the new legislation did provide additional tools in FDA's toolbox to better protect the American people. It was a positive step toward restoring the public's trust in the FDA.

Today, I am here to talk about another FDA bill. Last summer, I started examining FDA's program for inspection of foreign pharmaceutical manufacturing plants. I expressed concerns to the FDA regarding, among other things, inspection funding, emerging exporters, and weaknesses in the inspection process.

An increasing amount of the drugs and active pharmaceutical ingredients (API) Americans use are being manufactured in foreign countries. Yet, as reported by the Government Accountability Office in November 2007, the Food and Drug Administration does not know how many foreign establishments are subject to inspection and the agency conducts relatively few inspections each year.

From fiscal year 2002 through fiscal year 2007, the FDA conducted fewer than 1,400 inspections of foreign pharmaceutical facilities, often focused in countries with few reported quality concerns. In China, the world's largest producer of active pharmaceutical ingredients, and where export safety appears to be a growing problem, only 11 inspections were conducted during FY 2007, compared to 14 in Switzerland, 18 in Germany, and 24 in France, all countries with advanced regulatory infrastructures. I was troubled by these numbers.

Then came the wake-up call in January of this year. FDA announced that Baxter International Inc. temporarily suspended production of its blood thinner heparin because of an increase in the reports of adverse events that may be associated with its drug. It was discovered that the active ingredient in heparin was contaminated and that the ingredient was produced at a facility in the People's Republic of China. Soon more recalls were announced. After several months, the FDA established a link between the contaminant found in heparin and the serious adverse events seen in patients that were given heparin. FDA's investigation of the source of the contamination highlighted significant weaknesses in oversight of the production and supply chain.

With limited inspection resources, the FDA is charged with ensuring the safety and efficacy of drugs and pharmaceutical ingredients produced in nearly every corner of the globe. To make matters worse, as the FDA's challenges multiply, its resources for foreign inspections are shrinking. It is troubling that the FDA is grossly under-resourced at a time when foreign production of drugs and active pharmaceutical ingredients is growing at record rates. Adding to the difficulty of this task, it appears that many foreign pharmaceutical plants register with the FDA as a means to bolster their own standing and with no intention of exporting products to the United States market.

That is why I am introducing the Drug and Device Accountability Act today with Senator Kennedy, chairman of the Committee on Health, Education, Labor, and Pensions.

This legislation would augment FDA's resources through the collection of registration and inspection fees. The bill also expands the agency's authority for ensuring the safety of drugs and medical devices, including foreign manufactured drugs and devices, by expanding FDA's authority to inspect foreign manufacturers and importers, allowing the FDA to issue subpoenas, and allowing the FDA to detain a device or drug when its inspectors have reason to believe the product is adulterated or misbranded.

In addition, the bill includes a provision that expands on an amendment I filed last spring to the Senate bill, S. 1082 Food and Drug Administration Revitalization Act. That amendment provided for a certification by drug manufacturers that the information submitted as part of a new drug or supplemental application is accurate.

Under the Drug and Device Accountability Act, individuals responsible for the submission of a drug or device application or a report related to safety or effectiveness would have to certify that the application or report is compliant with applicable regulations and not false or misleading. Civil as well as criminal penalties could be imposed for false or misleading certifications. I believe this is an important provision, especially in light of the troubling findings presented in the Journal of the American Medical Association in April. Based on a review of documents from recent litigation involving the pain medication Vioxx, the authors of those articles concluded that the maker of Vioxx was not forthcoming in its communication with the Food and Drug Administration about the mortality risks seen in clinical trials of Vioxx conducted in patients with Alzheimer disease or cognitive impairment.

Last year, Congress passed legislation that would strengthen FDA's ability to act on emerging safety problems. Now we need legislation that will enhance FDA's oversight of drugs and devices if the Agency is to ensure that America's increasingly foreign-produced drug and device supply is both safe and effective.

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