[Congressional Record (Bound Edition), Volume 155 (2009), Part 12]
[Senate]
[Pages 15581-15582]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           HEALTH CARE REFORM

  Mr. BROWN. Madam President, as Members of the Senate and the House 
tackle health reform, two overriding objectives have become apparent. 
We must bring down cost and we must expand access, while allowing 
people who are happy with their health care to stay in the plan they 
are in now. Fix what is broken; preserve what works. Perhaps nowhere 
are these needs more obvious than the area of biopharmaceuticals or so-
called biologics. Biologics are the fastest growing segment of 
prescription drug spending. With costs to biologics ranging anywhere 
from $10,000 to $200,000 per patient per year, biologic treatments pose 
a significant financial challenge for patients, for insurance 
companies, for employers who are paying the bills, and for Federal and 
State governments that are also paying the bills. Let me give examples.
  If you suffer from an inflammatory condition such as rheumatoid 
arthritis or psoriasis or Crohn's disease, you probably would be 
prescribed Enbrel or Humira or Remicade. These biologics cost about 
$14,000 a year, more than $1,000 a month. Do you know what that does to 
an individual's pocketbook, an insurer or taxpayer? If you are 
diagnosed with multiple sclerosis--as 200 Americans are per week, some 
30 Americans every day--you would probably be prescribed an interferon 
like Avonex, Betaseron, or Rebif, at a cost of $19,000 per year. If you 
need Zevalin to treat lymphoma, which strikes nearly 75,000 Americans 
every year, it costs up to $30,000 for a full round of treatment.
  When other prescription drugs go off patent, after they have had 
patent protections for many years, there is a process at the Food and 
Drug Administration for approving lower cost generic versions. So you 
will see, when you go to a drugstore, many drugs which now are off 
patent. They have provided good profits for the developer, the drug 
company, but they are now off patent. So there could be generic 
competition in many of the drugs we use. That has worked to keep the 
price down and to bring competition to the industry. But no such 
process for biologics exists, no allowance of a generic substitute to 
compete with the biologic.
  As it stands, biologic manufacturers are in the envious position of 
having a permanent monopoly. No one can compete with them. Even after 
their patent has expired, FDA, under law, cannot legally approve 
competing products because of a gap in FDA law. At this point the only 
thing that stands in the way of establishing a generic approval process 
for biologics is the political muscle of the biologics industry. Here 
is what the industry tells us. They don't want any kind of approval 
process for generic biologics. They don't want competition. They want 
to continue to charge $14,000 if you have Crohn's disease, $19,000 if 
you have MS, and $30,000 per round of treatment for the 75,000 
Americans who have lymphoma.
  If we do establish such a process, they want to render it useless by 
granting biologics the equivalent of a permanent patent extension. 
Maybe you give them 12 years. After 12 years, you allow a generic, 
unless they slightly change a molecule or a process and you get another 
12 years and another 12 years and another 12 years. So in addition to 
20 years worth of patent protection, they want 12 years of market 
exclusivity which has the exact same effect as patent protection. When 
FDA grants a drug market exclusivity, it means that FDA will not 
approve any generic version of that drug, period.
  After the first 12 years of market exclusivity is over, the biologics 
industry wants to slightly modify their product, and they get another 
12 years of market exclusivity. And if they slightly modify the product 
again, they want another 12 years and another. In other words, they 
want no generic competition.
  We have generic competition in all kinds of drugs that are very well 
known, but there is no provision for any kind of generic competition 
for these biologics. The Federal Trade Commission, the government 
agency with no skin in the game, with no belief that one product is 
better than another, with no ties to the drug industry, with no ties to 
anybody, issued a report asserting that the biologics industry gets 
plenty of marketplace protection through patents and they should not be 
afforded even 1 day of market exclusivity, much less 12 or 24 or 36 
years.
  AARP recently reported that the top 10 biologics recoup their R&D 
investment after 2 years of sales. The industry claims they need 
decades sometimes to recoup their investment. But the AARP doesn't make 
this stuff up. Biologics manufacturers, even though AARP said they only 
need 2 years of sales to recoup their investment, are given more time 
than that so they can make a healthy profit. Yet biologics 
manufacturers are asking for 20 years of patent protection, coupled 
with 12 more years of market exclusivity; again, renewed over and over. 
That is the way they like it. The biologics industry wants us to go 
home and tell constituents with arthritis or respiratory illness, 
hemophilia, cancer, or multiple sclerosis, numerous other conditions 
now treated by biologics, if they are lucky, in 24 or 36 years they 
will have access to treatments that are more affordable.
  If we care about patients and fiscal responsibility, we will not 
allow the biologics industry to bully us into giving them more 
marketplace protection than any other industry. But it will take the 
personal will of Members from both sides of the aisle to overcome the 
biologic industry's clout.
  Some Members of this body have already taken a stand. I was proud to 
join Senator Schumer, Senator Collins, Senator Vitter, and Senator 
Bingaman--Democrats and Republicans--to introduce legislation that 
would close the gap on FDA law that prevents generic versions of 
biologics from being approved. This legislation is a compromise. It 
would provide 5 years of market exclusivity--remember, they already 
have patent protection--the same as that provided to other prescription 
drugs. Then they would be eligible for an additional 3 years of market 
exclusivity for beneficial changes to their products and even more 
exclusivity if they conduct pediatric tests on their product. This 
tiered approach, which I hope to include as part of the health care 
reform bill moving through the HELP Committee, would provide needed 
competition, long-term savings, and an opportunity for consumers to 
have safe, effective, and affordable medical treatments.
  I credit the manufacturers and the scientists and thank them, the 
medical researchers, for this. They provide great promise and hope to 
those suffering from devastating diseases and chronic illness. But 
absent price competition, countless Americans will be

[[Page 15582]]

unable to benefit from these medicines because they are too expensive. 
We are talking about tens of thousands of dollars a year just for this 
drug treatment, this biologic treatment, let alone all the other 
doctors' bills and medicine they would need.
  I hope when my colleagues are lobbied by the biologics industry--and 
they are spending millions of dollars on this because it means hundreds 
of millions of dollars in more profits for them--I hope when my 
colleagues are lobbied by the biologics industry, they will remember 12 
plus 12 plus 12. It simply does not work for us. The American patients, 
American businesses, and American taxpayers cannot afford to wait 12 or 
24 or 36 years for affordable biologics. Frankly, we should not make 
them wait.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Delaware.
  Mr. KAUFMAN. Madam President, I ask unanimous consent to speak as in 
morning business for up to 10 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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