[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Pages 17102-17103]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     DRUG QUALITY AND SECURITY ACT

  Mr. BENNET. I have to say what a joy it is to see the Presiding 
Officer in that Chair, and welcome to the Senate.
  I am here to talk about the Drug Quality and Security Act for a few 
minutes because at this moment of dysfunction in the Congress, we are 
at the brink of accomplishing something we have not been able to do for 
the last 25 years--the last quarter of a century.
  This bill, which we are about to send to the President, reforms our 
drug distribution supply chain, making it more secure and safer for 
families. It puts us

[[Page 17103]]

on a path to electronic interoperable tracing at the unit level for 
drugs.
  It also raises the bar for wholesale distributors around the country 
and weeds out bad actors who find loopholes in the system to stockpile 
drugs and create shortages. This bill cannot come soon enough.
  Our Colorado pharmacies fill over 60 million prescriptions every 
single year, and the Coloradans who take these prescriptions, just like 
people all over the country, expect their medicine to be safe. The sad 
fact is that given the current laws in place, we cannot guarantee this. 
Pharmacists cannot determine with any certainty where a drug has been 
and whether it has been secured and safely stored on its way to a 
pharmacy. Right now you can get more data from a barcode on a gallon of 
milk than you can from one bottle of aspirin two aisles over in the 
store.
  The normal chain moves drugs from the manufacturer to a wholesaler to 
a pharmacy. Under the current patchwork of State laws, drugs travel 
back and forth across State lines among repackagers, wholesalers, and 
pharmacies with no real oversight by anybody.
  The more times a drug goes back and forth and changes hands, the more 
opportunities criminals find to enter the system. In the last decade 
this lack of oversight has created an enormous gray market in the 
United States of America. Companies can stockpile drugs that are in 
high demand and sell them later at dramatically higher prices.
  Hospitals in Colorado are bombarded by daily calls and messages from 
various businesses around the country offering them drugs that are on 
the FDA drug shortage list and unavailable through their contracted 
wholesaler.
  According to a recent study by Premier Alliance, which includes 30 
Colorado hospitals, sale prices of drugs that are in shortage are, on 
average, 650 percent higher than the contracted prices. These hospitals 
have absolutely no idea whether the businesses that are approaching 
them are reputable and how they can have supply of these drugs that are 
in shortage.
  Investigations into the gray market have shown that the current law 
offers a huge incentive to make outrageous profits at the expense of 
patients, whether through selling and reselling or counterfeiting or 
tainting drugs.
  A little over a decade ago, criminals in Florida made $46 million by 
counterfeiting 110,000 dosages of Epogen, a drug used to treat anemia--
a side effect of chemotherapy and dialysis. These criminals sold the 
counterfeit drugs to pharmacies around the country. The FDA recovered 
less than 10 percent of the counterfeit product.
  In 2009, nearly 130,000 vials of insulin, a temperature-sensitive 
drug to treat diabetes, were stolen and later found across the country 
in a national pharmacy chain. The FDA--which had been notified that 
patients who used some of this insulin were reporting poor control over 
their insulin levels--was able to recover less than 2 percent of these 
stolen drugs.
  A few years ago $75 million worth of drugs were stolen from an Eli 
Lilly warehouse and later found in south Florida--becoming the largest 
drug heist in the country's history.
  Just this year the FDA notified the public about counterfeit Avastin, 
a drug used to treat cancer, which was being sold from a licensed 
wholesaler in Tennessee.
  These stories should scare any person in any State who takes a 
prescription. Fortunately, the practical compromise before us today 
will give consumers and businesses around the country peace of mind.
  Over the next decade, manufacturers, repackagers, wholesale 
distributors, and pharmacies will form an electronic interoperable 
system to track and trace drugs at the unit level. The barcode on our 
pill bottles will soon tell us who has actually handled the medicine we 
take and give to our children.
  Starting in 2015, the FDA will also know where every drug wholesaler 
is located across the country and begin to ensure that all wholesalers 
meet a minimum national standard.
  This legislation, after 25 years, is a model of what can be 
accomplished through hard work and pragmatism in the U.S. Congress. 
This bipartisan effort has the support of business groups, such as 
PhRMA, GPhA, and BIO, as well as consumer groups, such as the Pew 
Charitable Trusts, and many others.
  I cannot say enough about the leadership of Chairman Harkin and 
Ranking Member Alexander in driving us to get consensus on this bill. 
Their commitment to track and trace, as well as compounding, sets an 
example that I wish could be replicated many times over.
  I thank Senator Franken and Senator Roberts for their leadership on 
the compounding part of this bill.
  Finally, I want to acknowledge the relentless--and that is the only 
way to describe it--effort of Senator Richard Burr. He has been a true 
advocate and outstanding partner with me and my staff. His tireless 
efforts, and that of his staff, helped us move this legislation into 
law.
  While we are on that topic, and to close, I thank all of the staff 
who have worked on this important legislation.
  I ask unanimous consent that their names be printed in the Record at 
the conclusion of my remarks.
  I hope we have a strong show of support for this bill--as I know we 
will--on the floor of the Senate so we can get it to the President's 
desk. This bill will restore a sense of safety about our pharmaceutical 
distribution chain.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

       Rohini Kosoglu, Senator Bennet; Anna Abram, Senator Burr; 
     Jenelle Krishnamoorthy, Senator Harkin; MarySumpter Lapinski, 
     Senator Alexander; Elizabeth Jungman, Senator Harkin; Grace 
     Stuntz, Senator Alexander; Nathan Brown, Senator Harkin; 
     Molly Fishman, Senator Bennet; Margaret Coulter, Senator 
     Burr; Pam Smith, Senator Harkin; David Cleary, Senator 
     Alexander; Hannah Katch, Senator Franken; Jennifer Boyer, 
     Senator Roberts.

  Mr. BENNET. I yield the floor.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. LEAHY. Mr. President, I realize the Presiding Officer is not 
allowed to respond, but I want to add my words to those of the 
distinguished Senator from Colorado that I am delighted to see the 
Senator in the Chair. Again, as I did the other day, I welcome him to 
the Senate.

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