[Congressional Record Volume 147, Number 147 (Tuesday, October 30, 2001)]
[Senate]
[Pages S11190-S11191]
From the Congressional Record Online through the 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 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
[[Page S11191]]
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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