[Congressional Record (Bound Edition), Volume 162 (2016), Part 2]
[Senate]
[Page 1983]
[From the U.S. Government Publishing Office, www.gpo.gov]




       ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT

  Mr. HATCH. Mr. President, today I wish to discuss S. 483, the 
Ensuring Patient Access and Effective Drug Enforcement Act, which the 
Judiciary Committee reported out by voice vote right before we went 
into recess. At the outset, I would like to thank Senator Whitehouse 
for his important work on this bill. He and his staff have been crucial 
partners in helping to move this legislation forward.
  S. 483 will bring much-needed clarity to several key provisions of 
the Controlled Substances Act. In particular, it will better delineate 
the standards a company must satisfy in order to obtain a Controlled 
Substances Act registration and the circumstances under which a 
registration may be suspended without an adjudicative proceeding.
  To elaborate briefly on this second point, under the terms of the 
Controlled Substances Act, the Attorney General may suspend a 
registration to manufacture or distribute controlled substances without 
court process if she determines there is an imminent danger to the 
public health and safety, but the Controlled Substances Act does not 
define what constitutes an imminent danger. S. 483 clarifies the 
Attorney General's authority under this provision by specifying that 
imminent danger means that, ``due to failure of the registrant to 
maintain effective controls against diversion or otherwise comply with 
the obligations of a registrant under this title or title III, there is 
a substantial likelihood of an immediate threat that death, serious 
bodily harm, or abuse of a controlled substance will occur in the 
absence of an immediate suspension of the registration.''
  It is the intent of the bill authors that the phrase ``substantial 
likelihood of an immediate threat that death, serious bodily harm, or 
abuse of a controlled substance will occur'' include situations where 
evidence of diversion indicates there is a substantial likelihood that 
abuse of a controlled substance will occur--that is it is the intent of 
the authors that this language authorize the Attorney General to issue 
an immediate suspension order in cases where evidence of diversion 
points to a substantial likelihood of abuse, provided the other 
conditions for issuing such an order are met.
  In addition to these important clarifications, S. 483 will also 
facilitate greater collaboration between registrants and relevant 
Federal actors in combatting prescription drug abuse. In particular, 
the bill provides a mechanism for companies who inadvertently violate 
the Controlled Substances Act to submit a corrective action plan to 
remediate the violation before their registration is suspended and the 
supply of drugs to patients is interrupted. This provision will 
encourage greater self-reporting of violations and promote joint 
efforts between government and private actors to stem the tide of 
prescription drug abuse. It will also help ensure that supply chains 
remain intact for legitimate uses such as the alleviation of pain and 
illness.
  S. 483 takes a balanced approach to the problem of prescription drug 
abuse. It clarifies and further defines the Attorney General's 
enforcement powers while seeking to avoid situations that may lead to 
an interruption in the supply of medicine to suffering patients. It 
reflects a measured, carefully negotiated compromise between 
stakeholders and law enforcement that will enable both to work together 
more effectively. I thank Senator Whitehouse again for his work on this 
bill and urge my colleagues to give it their strong support.

                          ____________________