The Consumer Health Alliance for Safe Medication (CHASM; Alexandria, Virginia) reported that it has submitted a citizen petition to the FDA urging the agency to enforce public safeguards relating to manufacturing, promotion and dispensing of what it termed "unapproved respiratory medications."
CHASM, described as a coalition of patients, nurses, physicians and respiratory therapists, is calling for greater transparency from pharmacy manufacturers of compounded (mixed in a pharmacy) respiratory drugs.
Nancy Sander, president of Allergy & Asthma Network Mothers of Asthmatics, said, "Consumers generally believe that all prescription medications are approved by the FDA as safe and effective. However, an increasing number of pharmacy businesses are manufacturing, promoting and dispensing unapproved respiratory drugs as substitutes for FDA-approved medications. Without their knowledge, patients with asthma, emphysema and other respiratory conditions are increasingly exposed to unnecessary health risks associated with these medications."
She called CHASM's petition "a first step in demanding that the FDA take immediate action on this important issue."
The petition specifically requests that the FDA confirm that the law requires pharmacy businesses that promote or dispense CADIs to provide the information necessary to make informed decisions when using or prescribing these products; make the general public aware of this requirement; and write a regulation that specifies how the material facts are to be displayed and worded in product labeling and in advertisements.