[Congressional Record Volume 165, Number 22 (Tuesday, February 5, 2019)]
[Senate]
[Pages S868-S869]
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, Ms. Baldwin, Mr. Blumenthal, Mr. Booker, Mr. 
        Brown, Ms. Collins, Mr. Cotton, Mr. Cruz, Mr. Daines, Mr. 
        Durbin, Ms. Ernst, Mrs. Fischer, Ms. Hassan, Mr. Kennedy, Mr. 
        King, Mr. Menendez, Ms. Murkowski, Mr. Paul, Mr. Rounds, Ms. 
        Smith, Ms. Stabenow, Mr. Tester, Mr. Whitehouse, and Mr. 
        Young):
  S. 340. 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; 
read the first time.
  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 of companies 
raising the cost of their products overnight, pricing too many families 
out of the prescription drugs they need to survive. Just last week, 
House and Senate Committees charged with oversight of the 
pharmaceutical industry heard heartbreaking testimony from family 
members of those dependent on insulin who have been forced to ration 
their treatment because the annual cost of insulin has nearly doubled 
since 2012. That is appalling, and putting Americans into that kind of 
situation is unacceptable.
  Lawmakers across the political spectrum, including President Trump, 
agree that Congress needs to act to rein in these spiraling 
prescription drug prices. 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 (CREATES) 
Act, bipartisan legislation to end inappropriate delay tactics that are 
used by some brand-name drug companies to block competition from more 
affordable generic drugs. I am glad to be joined by Senators Grassley, 
Klobuchar, Lee and 24 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 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 misuses regulatory safeguards as a weapon to block 
competition.
  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 CREATES Act 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. Recognizing the effect these tactics 
have in keeping drug prices high, in May 2018, FDA for the first time 
publicly identified brand-name drug companies that abuse FDA's safety 
programs or enact their own restricted distribution systems to delay 
competition from generic and biosimilar manufacturers. The FDA's list 
shows 164 inquiries covering more than 50 prescription drugs where 
access to samples was at issue. In recent years, according to FDA 
testimony to Congress, the number of inquiries has increased.
  I share the concerns of Vermonters and Americans across the country 
that many prescription drugs are simply too expensive. I hear this 
again and again, from Vermonters in every corner of our state. When 
brand companies can artificially raise the price of drugs by using 
predatory practices, patients suffer. Illnesses worsen. Families, 
government programs, and other payers in the healthcare system 
ultimately bear those added, unnecessary costs.
  Making meaningful reform to reduce the cost of prescription drugs 
should be a top priority for all lawmakers. The CREATES Act is an 
important piece of that puzzle, and is widely supported across the 
political spectrum and has

[[Page S869]]

been endorsed by more than 90 groups. The Congressional Budget Office 
estimates that the CREATES Act would lower Federal spending on 
prescription drugs by $3.9 billion and research shows that the savings 
to patients with employer-based health insurance and the health care 
system overall would be far greater--many billions of dollars more.
  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 we can 
finally act together to help put more affordable prescription drugs in 
the hands of Americans.

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