[Congressional Record Volume 163, Number 72 (Thursday, April 27, 2017)]
[Senate]
[Page S2619]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LEAHY (for himself, Mr. Grassley, Ms. Klobuchar, Mr. Lee, 
        Mrs. Feinstein, Mrs. McCaskill, Ms. Collins, Mr. McCain, Mr. 
        Blumenthal, Mr. Whitehouse, Mr. Cotton, and Mr. Durbin):
  S. 974. A bill to promote competition in the market for drugs and 
biological products by facilitating the timely entry of lower-cost 
generic and biosimilar versions of those drugs and biological products; 
to the Committee on the Judiciary.
  Mr. LEAHY. Mr. President, over the past few years, the national 
headlines have been dominated by stories about the high cost of 
pharmaceuticals. We have seen jaw-dropping examples, such as the 
unconscionable price increase overnight by Turing Pharmaceuticals of 
their drug for patients with HIV, from $13.50 to $750 per pill.
  Pharmaceutical companies should be compensated for their important 
work developing lifesaving treatments. But when companies engage in 
predatory practices at the expense of consumers, we must act. That is 
why today I am reintroducing the Creating and Restoring Equal Access to 
Equivalent Samples, or CREATES, Act, bipartisan legislation to end 
inappropriate delay tactics that are used by some brand-name drug 
manufacturers to block competition from more affordable generic drugs. 
I am glad to be joined by Senators Grassley, Klobuchar, Lee, and 
Feinstein, and several other Senators of both parties in introducing 
this bill today.
  The first delay tactic addressed by the CREATES Act involves the 
withholding of drug samples that generic manufacturers need to gain 
regulatory approval. Federal law requires generic competitors to prove 
that their low-cost alternative is as equally safe and effective as the 
brand-name drug with which they wish to compete. Unfortunately, some 
brand-name companies are preventing generic manufacturers from 
obtaining the samples they need to make the necessary comparison. This 
simple delay tactic uses regulatory safeguards as a weapon to block 
competition. The FDA has reported receiving more than 100 inquiries 
from generic product developers who were unable to access samples of a 
brand-name drug to compare their generic product.
  The second delay tactic addressed by the CREATES Act involves the 
development of shared safety protocols. For some high-risk drugs, 
Federal law requires a generic drug manufacturer to join the brand-name 
drug manufacturer in a single, shared safety protocol for distribution 
of the drug. Despite this requirement, some brand-name companies are 
refusing to negotiate shared safety protocols with potential generic 
competitors, again undermining those competitors' ability to gain FDA 
approval for their generic versions of such drugs.
  The revised version of the CREATES Act also allows the FDA more 
discretion to approve alternative safety protocols, rather than require 
parties to develop shared safety protocols. Any safety protocol 
approved by the FDA must meet the rigorous statutory standards already 
in place.
  These exclusionary practices thwart competition and deny consumers 
the benefit of lower drug prices. I share the concerns of Vermonters 
and Americans across the country that many prescription drugs are 
simply too expensive. When brand companies can artificially raise the 
price of drugs by using predatory practices, patients suffer. Illnesses 
get worse. Families, government programs, and other payers in the 
healthcare system ultimately bear those added, unnecessary costs.
  This legislation is not a silver bullet to address all of the complex 
problems driving the high costs of medications. In addition to the 
delayed entry of generic drugs, I am troubled by the rising cost of 
treatments for opioid overdoses, which remain expensive for local law 
enforcement agencies, even though there are generic competitors. In 
Vermont, many patients are grappling with the extremely high cost of a 
new drug for hepatitis C that will likely have years of market 
exclusivity before generic alternatives can be made. Last year we 
learned the price of EpiPen had increased by almost 500 percent since 
2009, now costing roughly $600 for a two-pack. The sharp increase in 
price combined with the relatively short shelf life of the product--1 
year to 18 months--has put this lifesaving drug out of reach for many.
  Think for a moment about the impact of price hikes on the family of a 
patient facing a life-threatening illness. Across the country, 
hardworking Americans feel like the system is rigged against them by 
corporations that are looking to make a profit at any price. With 
examples like Turing and Mylan, it is no wonder they feel that way.
  The CREATES Act is one piece of the puzzle, addressing 
anticompetitive behavior that delays the creation of affordable generic 
drugs. Drug affordability is a bipartisan issue that affects each and 
every American. These reforms will make a difference. I hope other 
Senators will join us in supporting these bipartisan reforms.
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