[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[Extensions of Remarks]
[Page 8127]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          PERSONAL EXPLANATION

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                        HON. CAROLYN B. MALONEY

                              of new york

                    in the house of representatives

                         Thursday, May 31, 2012

  Mrs. MALONEY. Mr. Speaker, on May 30, I attended a family event and 
missed rollcall votes Nos. 294, 295, and 296. Had I been present, I 
would have voted ``aye'' on each of these votes. Specifically, I 
believe that rollcall vote 294, the Prescription Drug User Fee 
Amendments of 2012 is critical to the health and safety of all 
Americans. It ensures that people have access to crucial medicines and 
medical devices, improves access to new and innovative medicines and 
devices, helps prevent and mitigate drug shortages, and reduces drug 
costs for consumers by speeding the approval of lower-cost generic 
drugs. Very importantly, the bill includes important provisions to help 
prevent and mitigate drug shortages which have become too frequent and 
with dire consequences. These provisions include:
  Require manufacturers of critical or life-saving drugs to notify the 
agency within six months, or as soon as possible, of an interruption or 
permanent stop in manufacturing;
  Require FDA to expedite the review and approval of manufacturing 
changes that could help mitigate or prevent a shortage;
  Require FDA to maintain a public updated list of drugs experiencing 
shortages.

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