[Congressional Record Volume 155, Number 148 (Wednesday, October 14, 2009)]
[Senate]
[Pages S10436-S10437]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. SHAHEEN (for herself and Mr. Vitter):
  S. 1778. A bill to amend the Federal Food, Drug, and Cosmetic Act 
with respect to generic drugs, and for other purposes; to the Committee 
on Health, Education, Labor, and Pensions.
  Mrs. SHAHEEN. Mr. President, I rise today to introduce two health 
care bills that will help control health care costs and provide 
patients with better care. I believe these bills are easy to understand 
and reflect commonsense approaches to controlling health care costs.
  The first bill, the Reducing Emergency Department Utilization through 
Coordination and Empowerment, or REDUCE Act, S. 1281, would reduce 
costly and excessive emergency room visits by providing patients with 
more consistent and coordinated care.
  Emergency room overutilization is a source of wasteful spending in 
our health care system. Estimates show that $14 billion are wasted each 
year in unnecessary emergency room visits. It drives up the cost of 
health care and leads to overcrowding of our emergency rooms.
  Frequent users of emergency room services make up a small, but very 
costly portion of the population. These individuals tend to have 
multiple chronic illnesses and severe mental illness. They often live 
in poverty or are homeless. Many times they use the emergency room 
because they have nowhere else to go.
  In the most extreme cases, these individuals can cost the system 
millions of dollars. You heard right, one person can put a multi-
million dollar strain on our health care system. For example in Camden, 
NJ, one person cost taxpayers $3.5 million over 5 years in Medicaid and 
Medicare payments.
  We need to fix this problem, and I believe we can. The REDUCE Act is 
modeled after successful pilot programs across the country. It provides 
beneficiaries with a care management team consisting of a medical 
provider, a social worker and a community health worker that can 
provide medical care and support in any setting. The care management 
team also helps to ensure that these individuals are going to their 
primary care doctors and mental health providers on a regular basis.
  Research shows it works. In fact, after two years of enrollment in 
one pilot program, on average, individual emergency room visits were 
reduced by 61 percent and emergency room charges were reduced by 59 
percent for those that participated.
  There is a lot we need to do to reform our health care system, but as 
we work on reform broadly, we also need to focus attention on 
individuals, especially these high cost patients. Doing so will improve 
care for this vulnerable population and reduce costs.
  The second bill, the Access to Affordable Medicines Act, S. 1778, 
will increase access to lower cost generic drugs by closing a loophole 
some brand name drug companies exploit that needlessly and unfairly 
delays the entry of safe, lower-cost generic drugs to the consumer 
market.
  As the law currently stands, when brand name manufacturers make 
labeling changes, generic drug labeling must reflect this change prior 
to the drug being approved and introduced in the market.
  Too often, big pharmaceutical companies make last minute changes to 
the label. Many times the labeling changes are insignificant and do not 
deal with safety or warnings. In fact, these last minute changes are 
often used by brand name pharmaceutical companies to purposefully delay 
the introduction of cost-saving generic drugs by weeks or months. This 
can cost consumers and the federal government millions of dollars.
  My bill would stop these costly practices by providing a 60-day grace 
period for the generic drug company to submit the new labeling for 
approval and marketplace distribution, while preserving safeguards if 
the new labeling truly presents a safety issue.

[[Page S10437]]

  As we work to pass comprehensive health care reform in Congress, we 
do it with families and small businesses who struggle everyday with the 
high cost of health care in mind. These bills are the types of sensible 
reforms that we need to make so that the health care system is more 
affordable and more efficient. I look forward to working with my Senate 
colleagues on this legislation.
                                 ______