[Congressional Record (Bound Edition), Volume 158 (2012), Part 4]
[Extensions of Remarks]
[Page 5165]
[From the U.S. Government Publishing Office, www.gpo.gov]




      H.R. 4384--PATIENT SAFETY AND DRUG LABELING IMPROVEMENT ACT

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                          HON. BRUCE L. BRALEY

                                of iowa

                    in the house of representatives

                       Wednesday, April 18, 2012

  Mr. BRALEY of Iowa. Mr. Speaker, the Patient Safety and Drug Labeling 
Improvement Act is meant to address a troubling inconsistency in the 
law, created by Pliva v. Mensing, which does not allow consumers 
injured by generic drugs to hold the manufacturer accountable for 
inadequate warnings.
  The Mensing ruling also eliminates any incentive for generic drug 
manufacturers to monitor the safety of the products they sell and 
propose necessary changes to labeling to the FDA, as currently required 
by federal law.
  Under the Patient Safety and Drug Labeling Improvement Act 
manufacturers of generic drugs assume the same duties as brand 
manufacturers to monitor the safety of the drugs they sell and to 
ensure that their labeling contains accurate risk information. More 
specifically, the legislation authorizes generic drug manufacturers to 
independently initiate labeling changes through the Changes Being 
Effected (CBE) process under the same circumstances that apply to 
manufacturers of branded drugs in order to ensure that all drug labels 
accurately reflect current health and safety information.

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