[Congressional Record (Bound Edition), Volume 159 (2013), Part 9]
[Extensions of Remarks]
[Pages 13152-13153]
[From the U.S. Government Publishing Office, www.gpo.gov]




          THE INTRODUCTION OF THE S.A.F.E. COMPOUNDED DRUG ACT

                                 ______
                                 

                          HON. ROSA L. DeLAURO

                             of connecticut

                    in the house of representatives

                         Friday, August 2, 2013

  Ms. DeLAURO. Mr. Speaker, I rise today to introduce the Supporting 
Access to Formulated and Effective Compounded Drugs Act, or the 
S.A.F.E. Compounded Drug Act. My colleagues Congresswoman Nita Lowey of 
New York, Congressman Conyers of Michigan, and Congressman Honda of 
California are cosponsors of this legislation and I thank them for 
their work on this issue.
  This bill seeks to ensure that patients and health care providers 
across the country have access to safe compounded drug products.
  As you know, a devastating fungal meningitis outbreak last year was 
associated with contaminated products from a compounding facility in 
Massachusetts. Nearly 750 Americans became ill from these products and 
61 perished. Unfortunately, this tragic outbreak and the others we have 
seen since are not anomalies. They are the result of a broken system. 
My thoughts and prayers are with the individuals and families whose 
lives have been affected by these contaminated products.
  Earlier this week the Government Accountability Office released a 
report on drug compounding. That report noted that ``lack of consensus 
and differing FDA authority to oversee compounded drugs across the 
country has resulted in gaps in oversight.'' Gaps that clearly risk the 
public health.
  Just this week a compounding pharmacy announced the recall of more 
than 125 different types of sterile compounded products distributed 
nationally. Five days after the company began notifying its customers 
of the recall, a recall notice was published by the FDA. These products 
are being recalled because of a ``question of sterility assurance.'' 
Thankfully no illnesses have been identified, but it is imperative that 
we act now and not wait for another heart wrenching outbreak and ask 
ourselves if we could have prevented it in the first place.
  The bill I am introducing today should be part of our work to fix the 
system. It would do five things: clarify Federal authority of 
compounding pharmacies, improve patient and

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provider notification with accurate labeling, improve communication 
between Federal and state regulators, seek additional information to 
improve our understanding of the complexities related to compounded 
products, and strengthen penalties.
  I urge my colleagues to support this bill.

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