[Congressional Record (Bound Edition), Volume 162 (2016), Part 6]
[Senate]
[Page 8672]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. LEAHY (for himself, Mr. Grassley, Ms. Klobuchar, and Mr. 
        Lee):
  S. 3056. A bill to provide for certain causes of action relating to 
delays of generic drugs and biosimilar biological products; to the 
Committee on the Judiciary.
  Mr. LEAHY. Mr. President, in recent months, the high cost of 
pharmaceutical products has been front and center in national news, 
sometimes with astonishing examples like the unconscionable price-hike 
by Turing Pharmaceuticals of their drug for patients with HIV from 
$13.50 to $750 per pill overnight.
  Pharmaceutical companies should be compensated for their important 
work developing life-saving treatments, but when companies engage in 
predatory practices at the expense of consumers, we must act. That is 
why today, I am introducing the Creating and Restoring Equal Access to 
Equivalent Samples, 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.
  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 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 a shared safety protocol with potential generic 
competitors, again undermining those competitors' ability to gain FDA 
approval for their generic version of the drug.
  These exclusionary practices thwart competition and deny consumers 
the benefit of lower drug prices. They also undermine the careful 
balance created in the Hatch-Waxman Act and the more recent Biologics 
Price Competition and Innovation Act, which are designed to reward and 
incentivize innovation while ensuring that consumers ultimately benefit 
from the entry, after an appropriate time, of generic or biosimilar 
versions of a drug. Innovative companies can and should gain the 
benefit of their inventions. But when companies artificially extend the 
period of those benefits by using dilatory tactics to delay generic 
entry, the thoughtful balance of the Hatch-Waxman Act and BPCIA are 
plainly undermined.
  I share the concerns of Vermonters and Americans across the country 
that many pharmaceutical products are simply too expensive for 
consumers. Nearly \3/4\ of the public view prescription drug costs as 
unreasonable, and one in four patients say they have not filled a 
prescription because of cost. Parents should not be forced to choose 
between putting food on the table and getting their children and 
themselves the medicine they need. When drug prices are artificially 
inflated, patients suffer, illnesses become protracted, and families, 
government programs, and other payers in the healthcare system 
ultimately bear the cost. That is why this legislation is supported by 
consumer groups, physicians, insurance companies, pharmacists and 
hospitals who all see firsthand the impact of unreasonably high costs 
of some prescription drugs.
  Earlier this month, Vermont set an example for the Nation when it 
passed into law drug transparency legislation that will require 
pharmaceutical companies to justify large increases in their drug 
prices. Here in Washington, the Senate Aging Committee and other 
Committees have been doing important work to analyze the root causes of 
high drug pricing and find practical solutions. Solving this issue will 
require nuanced, thoughtful work on all sides to ensure that consumers 
are protected and that pharmaceutical companies that act in good faith 
can continue to innovate for patients.
  With the CREATES Act, the bipartisan leaders of the Senate Judiciary 
Committee and its Subcommittee on Antitrust, Competition Policy and 
Consumer Rights are using our roles to address anticompetitive behavior 
that blocks competition and delays the creation of affordable generic 
drugs. I thank Senators Grassley, Klobuchar and Lee for joining me in 
this effort, and for agreeing to hold a hearing on this bill as soon as 
next week.
  Drug affordability is a bipartisan issue that impacts each and every 
one of us. I hope other Senators will join us in supporting this 
bipartisan legislation.

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