[Congressional Record Volume 155, Number 60 (Thursday, April 23, 2009)]
[Senate]
[Pages S4686-S4687]
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. 882. 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, over the last 5 years I have conducted 
extensive oversight of the Food and Drug Administration. 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.
  The FDA will require strong leadership to rebuild public confidence 
and tackle the cultural and organizational problems that have plagued 
the agency.
  Strong leadership alone, however, will not fix all the problems.
  The agency needs additional tools, resources, and authorities to 
fulfill its mission of protecting the health and safety of the American 
people.
  In September 2007, the Congress passed the Food and Drug 
Administration Amendments Act to provide FDA some of the needed tools, 
resources, and authorities.
  This legislation was a positive step forward in strengthening the 
agency and restoring the public's trust in the FDA, but Congress's work 
is not done.
  Today, I am here to talk about another FDA bill.
  In the summer of 2007, I started examining FDA's program for 
inspections of foreign pharmaceutical manufacturing plants.
  I expressed concerns to the FDA regarding, among other things, 
inspection funding, emerging exporters, and severe weaknesses in the 
inspection process.
  An increasing amount of the drugs and active pharmaceutical 
ingredients Americans use are being manufactured in foreign countries, 
primarily in China and India.
  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 foreign inspections each year.
  According to the FDA, from fiscal year 2002 through fiscal year 2007, 
the agency conducted fewer than 1,400 inspections of foreign 
pharmaceutical facilities.
  And these inspections were often conducted in countries with few 
reported quality concerns.
  In China, the world's largest producer of active pharmaceutical 
ingredients, and where we have seen increasing reports of contaminated 
products, only 11 inspections were conducted during fiscal year 2007--
that is way too few.
  During the same year, FDA conducted 14 inspections in Switzerland, 18 
in Germany, and 24 in France--all countries with advanced regulatory 
infrastructures.
  In addition, FDA officials estimated that the agency inspected 
foreign class II device makers every 27 years and foreign class III 
device makers every 6 years.
  Class III devices are devices that support or sustain human life or 
present a potentially unreasonable risk of illness or injury, such as 
pacemakers and heart defibrillators.
  In January 2008, we saw too well what happens when we have a broken 
inspection system.
  Baxter International Inc. temporarily suspended production of its

[[Page S4687]]

blood thinner Heparin because of an increase in reports of adverse 
events that may be associated with its drug. Then recalls were 
announced. There were serious concerns about whether or not this 
country would have enough Heparin to meet patient needs as a result of 
the contamination. After several months, FDA's investigation found that 
the active ingredient in Heparin, which was made at a facility in 
China, was contaminated. And the serious adverse events in patients who 
received Heparin were linked to the contaminated blood thinner.
  The recalls and investigation of contaminated Heparin highlighted 
significant weaknesses in FDA's oversight of the production and supply 
chain and emphasized the need to improve FDA's protection of the safety 
of products made in this country and abroad.
  The FDA is charged with ensuring the safety and efficacy of drugs, 
pharmaceutical ingredients, and devices produced around the world 
despite its inadequate budget for inspections, in particular foreign 
inspections.
  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.
  Last Congress, I introduced the Drug and Device Accountability Act of 
2008 with Senator Kennedy, chairman of the Committee on Health, 
Education, Labor, and Pensions. The Congress did not have an 
opportunity to act on that legislation. So today Senator Kennedy and I 
are introducing the Drug and Device Accountability Act of 2009.
  Senator Kennedy is not able to join me on the Senate floor, but I 
thank him for his cooperation and work with my office on this important 
legislation.
  I also want to take this opportunity to express my appreciation for 
his commitment and efforts over the years to reform and improve the 
FDA.
  I am going to spend the next few minutes highlighting some of the 
things the Drug and Device Accountability Act of 2009 would do.
  This bill would augment FDA's resources through the collection of 
inspection fees.
  It 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 would require individuals responsible for 
submitting a drug or device application or a report related to safety 
or efficacy to certify that the application or report complies with 
applicable regulations and is 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 given the troubling findings 
over the last few years; that is, that some companies have withheld 
important safety information from the FDA or buried that information in 
their submissions to the agency.
  In addition, in light of recent serious allegations that have been 
raised by scientists within the FDA regarding the agency's handling of 
medical device reviews, the bill calls for an Institute of Medicine 
study to examine FDA's system for clearing and approving devices for 
marketing.
  During President Obama's weekly address last month, the President 
stated, ``There are certain things only a government can do. And one of 
those things is ensuring that the foods we eat, and the medicines we 
take, are safe and do not cause us harm.''
  I concur, and the Drug and Device Accountability Act is an 
opportunity for Congress to help FDA do a better job of ensuring that 
our increasingly foreign-produced drug and device supply is safe and 
effective.
  I look forward to working with my colleagues in the Senate and with 
the Obama administration to ensure that FDA has the necessary tools and 
resources to meet its oversight responsibilities.
                                 ______