[Congressional Record Volume 159, Number 77 (Tuesday, June 4, 2013)]
[Extensions of Remarks]
[Page E784]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           SAFEGUARDING AMERICA'S PHARMACEUTICALS ACT OF 2013

                                 ______
                                 

                               speech of

                        HON. ELIJAH E. CUMMINGS

                              of maryland

                    in the house of representatives

                          Monday, June 3, 2013

  Mr. CUMMINGS. Mr. Speaker, although this bill takes important steps 
to secure our nation's pharmaceutical supply chain, we need to do more 
to protect patients and the public health.
  For over a year, I have been investigating the problem of so-called 
``gray market'' drug companies that take advantage of critical drug 
shortages to charge exorbitant prices.
  Working with the Senate Commerce Committee and the Senate HELP 
Committee, we identified numerous cases in which gray market drug 
companies were able to get their hands on shortage drugs when hospitals 
and other providers could not. And in many cases, these middleman 
companies exploited national drug shortages by charging exorbitant 
mark-ups for drugs used to treat cancer and other life threatening 
conditions.
  This kind of price gouging is unconscionable, and it represents a 
serious threat to patients' health and safety.
  Our investigation found that in more than two-thirds of cases, 
prescription drugs entered the gray market through pharmacies. These 
pharmacies purchased their drugs from authorized distributors, but 
instead of dispensing them to providers or patients in accordance with 
state laws, the pharmacies re-sold them to gray market wholesalers.
  For these reasons, I introduced the Gray Market Drug Reform and 
Transparency Act to implement reforms in this area and to protect 
consumers and providers from exploitation.
  I am encouraged that the bill before us takes up one of my proposals, 
which is to require wholesalers to register and report annually to the 
FDA, including on their disciplinary actions. Although this is a step 
in the right direction, the bill fails to make this information 
publicly available, which is critical to consumers, healthcare 
providers, and state boards of pharmacy.
  The bill also fails to close the primary loophole by which drugs 
enter the gray market, by prohibiting wholesalers from buying drugs 
from pharmacies.
  We need to put an end to unethical profiteering at the expense of 
patients with cancer and other critical illnesses, and I hope we can 
add these common sense provisions to H.R. 1919 in conference 
negotiations.

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