[Congressional Record (Bound Edition), Volume 147 (2001), Part 15]
[Senate]
[Pages 20912-20913]
[From the U.S. Government Publishing Office, www.gpo.gov]



                       AGRICULTURE APPROPRIATIONS


                       medical device technology

  Mr. JOHNSON. Madam President, first I thank, Chairman Kohl and 
Senator Cochran for their outstanding work in putting together an 
excellent bill. An important part of this legislation provides funding 
for the Food and Drug Administration to perform its

[[Page 20913]]

vital mission to protect and promote the public health. That mission 
includes the essential work of evaluating the safety and effectiveness 
of promising new life-saving and life-enhancing medical device 
technologies so that they may be used with patients in an expeditious 
manner. However, we must be sure that the Center for Devices and 
Radiological Health (CDHR) are provided with the adequate resources to 
carry out their work. The number of patents issued in the medical 
device sector has increased by 30 percent in recent years. The private 
sector is committing substantial increases in funding to healthcare 
research and development. We are fortunate that the FDA will be faced 
with the task of evaluating many new technologies that will benefit all 
of us next year. It is my hope that we could review this issue in 
conference to ensure that the premarket review function at CDRH 
receives an appropriate level of funding to carry out their mission.
  Mr. DORGAN. I thank my colleague for raising this matter. It is my 
concern that the pre-market review function at the Center for Devices 
and Radiological Health does not have sufficient resources to keep up 
with the tremendous pace of innovation that is now taking place in the 
health sector. Despite the FDA's ongoing efforts to improve in this 
area, review times for breakthrough medical devices are lengthy and 
likely to get longer. While this bill makes important progress toward 
giving FDA the funds it needs to carry out its mission, I hope the 
chairman would work with us in conference to find a way to provide the 
resources needed to reduce medical device application review times.
  Mr. KOHL. I appreciate the remarks and understand the concerns 
expressed by my colleagues. I agree that patients should not have to 
wait for promising new therapies due to insufficient resources at FDA. 
Language in the report accompanying the Senate bill states that the 
increase received by FDA's Devices and Radiological Health Program for 
fiscal year 2002 is consistent with agency estimates for bringing 
medical device application review times within statutory limits. While 
this statement is accurate according to the budget submitted to 
congress by the FDA, I have been informed that in testimony to the 
House Appropriations Committee, FDA officials stated the agency would 
need more funds than requested in their budget to decrease application 
review times significantly. I believe it is important for us to work 
together to resolve this issue, and look forward to working with my 
colleagues and our House counterparts in the Conference Committee.
  Mr. VOINOVICH. Madam President, I was proud to offer an amendment to 
the fiscal year 2002 agriculture appropriations bill.
  The amendment I offered last week set aside $500,000 from the Office 
of Generic Drugs at the Food and Drug Administration for use in the 
education and dissemination of information to America's senior citizens 
regarding the efficacy, safety and availability of generic drugs.
  Currently, the FDA informs the public and providers about generic 
drugs through print advertising, reaching a limited number of 
individuals. It is my hope that this amendment will allow FDA to 
enlarge its outreach, utilizing not only print media, but also radio 
and television public service announcements.
  In the absence of a Medicare prescription drug benefit, it is 
imperative that Congress provide alternative avenues for seniors 
needing to lower their out-of-pocket prescription drug costs.
  Although millions of seniors already know about and use generic 
drugs, there are still many others who are not aware of their 
availability. Indeed, many highly used brand-name drugs whose patents 
have expired have generic alternatives available. These generic drugs 
are chemically identical in their active ingredient to their brand-name 
counterparts and are sold at substantial discounts from the branded 
price.
  For example, the prescription drug Kelflex, an antibiotic, costs 
approximately $88 per month. Its generic equivalent costs about $13 per 
month, a potential annual savings of $900 for an individual who uses 
this product. In fact, according to the Congressional Budget Office, 
generic drugs save consumers an estimated $8 to $10 billion per year at 
retail pharmacies.
  As each of my colleagues knows, the nature of health care has changed 
dramatically in America since the creation of Medicare in 1965. In many 
instances, diseases or conditions that once required hospitalization 
are now treated by pharmaceuticals. However, as advances in 
pharmaceuticals continue and the population ages, the Center for 
Medicare and Medicaid Services reports that national spending for 
prescription drugs is expected to more than double from an estimated 
$117 billion to $366 billion over the next ten years. Unfortunately, 
the financial burden on Medicare beneficiaries, those who use 
prescription drugs the most, will continue to increase. Consider the 
fact that Medicare beneficiaries account for 14 percent of the U.S. 
population, yet they consume approximately 43 percent of the nation's 
total drug expenditures and you can understand why we need to address 
this issue.
  $500,000 will ultimately only be a drop in the bucket in finding a 
solution to providing access to affordable prescription drugs to 
seniors. However, these funds will help provide valuable information to 
those who rely on medications the most. With greater reliance on 
pharmaceuticals, increased direct-to-consumer advertising and the 
increased empowerment of seniors, it is imperative that those who use 
prescription drugs become better educated about the availability of 
generic equivalents that are just as effective as their name-brand 
counterpart.
  While seniors wait for Congress to pass permanent prescription drug 
benefit legislation, the federal government should capitalize on other 
opportunities to aid seniors in their effort to obtain affordable 
prescription drugs.
  That is why I have offered this important amendment and why I will 
work with Secretary Thompson and the Department of Health and Human 
Services to provide seniors with thorough information regarding highly 
utilized drugs, their generic equivalent and comparative pricing, as 
well as any other pertinent information that is necessary to improve 
the health and quality of life of our senior citizens. This information 
would prove to be highly useful to seniors and could easily be included 
in the annual ``Medicare & You'' publication. Seniors are typically 
very knowledgeable consumers of health care, and whatever information 
we can provide is a critical way to help them bypass the high cost of 
prescription drugs.
  It is a sad reality that some senior citizens on fixed incomes do not 
take their full doses of their medications because they try to save 
money by stretching out their supply. Unfortunately, such self-
medication can lead to life threatening health considerations. The 
amendment I offered will help our seniors get the information they need 
on lower cost generic drugs so they may obtain the prescription drugs 
they need to live their lives to the fullest.
  I thank the manager and ranking member of the subcommittee for 
accepting this important amendment.

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