Drug Quality and Security Act

Floor Speech

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 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.

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