Chris Smith: “today, Americans with asthma, emphysema, and other respiratory diseases are being exposed, without their knowledge or…”

“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.…”