[Congressional Record Volume 151, Number 56 (Tuesday, May 3, 2005)]
[House]
[Page H2788]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     HEALTH RISKS ASSOCIATED WITH INHALED COMPOUNDED DRUGS USED IN 
                               NEBULIZERS

  The SPEAKER pro tempore (Mr. Reichert). Under a previous order of the 
House, the gentleman from New Jersey (Mr. Smith) is recognized for 5 
minutes.
  Mr. SMITH of New Jersey. Mr. Speaker, today, Americans with asthma, 
emphysema, and other respiratory diseases are being exposed, without 
their knowledge or consent, to serious and unnecessary health risks 
associated with inhaled compounded drugs used in their nebulizers.
  Mr. Speaker, to my left are FDA-approved generic and brand 
medications proven to be safe, effective, and manufactured in a sterile 
manner. I would ask Members to notice that critical information, such 
as lot number, expiration date, manufacturer, drug name, and dose are 
embossed on the plastic vial.
  These, Mr. Speaker, on this next board, are not FDA-approved 
medications. They were compounded or mixed in a pharmacy under 
conditions that may or may not be sterile. They are not clinically 
proven to be safe or effective. Notice there is no lot number, no 
expiration date, no manufacturer or sterility notice. Absence of this 
critical information in labeling and advertisements to patients and 
prescribers is, at best, misleading.
  In addition, notice here the glue-affixed paper labels. The FDA, Mr. 
Speaker, does not approve of these types of paper labels because they 
are known to leach carcinogenic ink and glue chemicals into the 
medication in the vials the patient inhales into their lungs.
  Mr. Speaker, physicians write their prescriptions for FDA-approved 
brand names and generic medications. Patients think that what the 
doctor prescribes is what they are going to receive. But through a 
sleight of hand, some compounding pharmacists are having the 
prescriptions switched to these types of unapproved and unproven drugs.
  What happens is that the patient gets a phone call or sees a TV ad or 
something on the Web saying that this seemingly benign and reputable 
company will deliver their nebulizer drugs right to their door if they 
just sign a form. By signing, they essentially agree to a substitution 
of the medication from what the doctor prescribed to whatever substance 
the compounding pharmacist is whipping up in his back room or factory.
  Oftentimes, the original prescribing physician does not even know the 
substitution or switch has occurred. Patients and physicians do not 
know until something goes tragically wrong, and wrong in this case can 
be a worsening symptom, or even death.
  You might ask how this is happening, Mr. Speaker. Well, a new 
industry has emerged in recent years: Mass pharmacy manufacturing under 
the guise of traditional pharmacy compounding. Relying on lax State 
standards and arguing that Federal standards do not apply, these 
companies manufacture and distribute millions of doses of compounded 
nebulizer medications each year. Mass pharmacy manufacturing is not to 
be confused with traditional pharmacy compounding, a public health 
service when a patient has a medical condition for which no proven 
commercially available medication exists.
  Normally, the patient, prescriber and compounding pharmacist discuss 
the risks and benefits together and monitor the patient carefully 
throughout the illness. In many cases, however, this is not happening. 
Medical experts agree that the risk of using these unproven drugs, mass 
manufactured outside the parameters of FDA regulation, are 
unacceptable, especially when FDA-approved medications are available.
  These drugs, Mr. Speaker, are not FDA-approved. They are not 
established generic equivalents of FDA-approved brand name medications. 
They are not proven to be safe or effective and do not meet FDA 
standards for sterility. The origin and quality of raw ingredients are 
not disclosed.
  The absence of disclosure and drug labeling in advertisements is 
indeed misleading, and I am concerned. So are patient and clinician 
organizations, led by the Allergy and Asthma Network/Mothers of 
Asthmatics. It is time for Congress to get to the bottom of this issue 
and find out why these products are allowed to be sold with misleading 
labeling and without FDA approval. And, further, why in many cases 
Medicare and Medicaid are reimbursing for these unproven and unapproved 
mass manufactured products.

                          ____________________