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Public Statements

Health Risks Associated with Inhaled Compounded Drugs Used in Nebulizers

By:
Date:
Location: Washington, DC


HEALTH RISKS ASSOCIATED WITH INHALED COMPOUNDED DRUGS USED IN NEBULIZERS -- (House of Representatives - May 03, 2005)

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.

http://thomas.loc.gov

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