[Congressional Record Volume 157, Number 21 (Thursday, February 10, 2011)]
[Senate]
[Pages S644-S645]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. SNOWE (for herself, Ms. Stabenow, Mr. Vitter, Mr. McCain, 
        Ms. Klobuchar, Mr. Grassley, Mr. Kohl, Ms. Collins, Mr. Brown 
        of Ohio, Mr. Kerry, Mr. Sanders, Mr. Levin, Mrs. Shaheen, Mr. 
        Leahy, Mr. Johnson of South Dakota, Mr. Bingaman, Mrs. 
        McCaskill, Mr. Begich, and Mr. Nelson of Florida):
  S. 319. A bill to amend the Federal Food, Drug, and Cosmetic Act with 
respect to the importation of prescription drugs, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Ms. SNOWE. Mr. President, I am proud to introduce the Pharmaceutical 
Market Access and Drug Safety Act of 2011. I am enormously grateful to 
partner with Senator Stabenow in this endeavor and to have the support 
of 17 additional bipartisan cosponsors. I also want to salute former 
Senator Byron Dorgan, who was such a tremendous ally on this issue for 
nearly a decade.
  During health reform, I was disappointed with the $80 billion deal 
struck by the drug industry in exchange for supporting the legislation. 
Make no mistake--this is hardly a generous offer from the industry. 
Consider the fact that last August, a report issued by AARP on retail 
prices of brand-name drugs showed that the 217 products most used by 
older Americans increased by an average of 8.3 percent during 2009, 
even as inflation was negative. So in other words, we have the industry 
setting a new pricing baseline that is entirely off kilter with the 
rest of the economy . . . widely unaffordable for the American people . 
. . and clearly unsustainable for the future. Negotiating concessions 
is no substitute for instilling market competition--which is exactly 
what this legislation will do.
  It is unconscionable that more and more individuals are forced to 
skip doses or split pills as prices increase while our economy 
contracts. Today our bill could already be providing the access that 
Americans deserve to the more affordable drug prices available in other 
industrialized nations. It is simply indisputable that Americans pay 
far too much for prescription drugs--when other countries pay 35-55 
percent less. And the cost of brand drugs in the U.S. increases at two 
to three times the inflation rate.
  When nations institute safe, regulated trade in pharmaceuticals they 
see results--as Sweden did when it entered the European system of trade 
and saw a reduction of 12-19 percent in the price of traded drugs. Now, 
opponents claim importation will cause harm, but they fail to note the 
greatest prescription drug threat to the safety of Americans . . . that 
the inability to take a drug as it is prescribed . . . exacts a 
tremendous toll on thousands of American lives every year.
  The bottom line is that safety is the foundation of our bill--our 
legislation not only addresses the safety of imports, but also was the 
first to provide FDA with the resources to improve inspection of 
foreign drug plants--many of which today produce medications marketed 
here by U.S. firms which consumers assume to be ``domestic.''
  They have also failed to understand or acknowledge we have left no 
stone unturned to assure importation will be safe . . . why we require 
FDA approval of all imported drugs . . . that the agency regulate, 
inspect and monitor those who handle medications . . . that we require 
strong prescription controls, improved labeling, anticounterfeiting 
technology and tracking of shipments to assure the security of 
medications. We don't rely on ``certifying safety''--this legislation 
ensures safety.
  Indeed when all the provisions of this legislation are considered, 
this legislation will set a new standard for domestic drug safety. 
Because, right now--today--many of the drugs which Americans use every 
day are in fact manufactured in foreign factories. Yet today foreign 
plants are seldom inspected--it can be as many as 12 years between 
inspections. The fact is, global sourcing

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of production to lower cost countries--including those with inadequate 
regulatory oversight--means that FDA simply must be examining all 
facilities where our medications are made.
  Under our bill, such plants--and in fact every step in the drug 
supply chain--are to be inspected and regulated by FDA. And we include 
long-sought incentives, to improve drug safety such as anti-
counterfeiting technologies, drug ``pedigrees,'' and improved 
regulation and oversight of the handling of prescription drugs.
  At the same time, this legislation will ensure that importation is 
effective in delivering savings to consumers. The Congressional Budget 
Office reports our bill will generate savings of $19.4 billion to the 
Federal Government alone. Isn't that exactly the kind of savings we 
should achieve at a time of escalating health care costs?
  So it is clear that the time for enactment of this legislation is 
certainly long overdue--and today the need for this legislation is 
actually greater . . . not less. Among working age adults--only those 
with Medicare coverage saw any improvement in their ability to fill 
their prescriptions. All others saw a rise in their inability to obtain 
needed medications! Among the uninsured more than 1 in 3 individuals 
went without a required prescription--and in those with chronic disease 
that number doubles! So despite manufacturer assistance programs--
despite the increased use of generics--the high and escalating cost of 
brand name drugs is directly impacting the health of millions.
  It is indeed time to engender more competition, and the more 
affordable pricing that will bring. That is why I look forward to 
moving forward together to see passage of our bill this year.
                                 ______