[Congressional Record Volume 154, Number 129 (Thursday, July 31, 2008)]
[Senate]
[Page S7968]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REID (for Mr. Kennedy (for himself and Mr. Grassley)):
  S. 3409. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
ensure the safety and quality of medical products and enhance the 
authorities of the Food and Drug Administration, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  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.
                                 ______