Consumer Health Alliance for Safe Medication Petitions FDA to Better Protect Patients

ALEXANDRIA, Va., March 24 /PRNewswire/ -- Today, the Consumer Health Alliance for Safe Medication (CHASM) submitted a Citizen Petition to the Food and Drug Administration (FDA) urging the agency to enforce public safeguards relating to manufacturing, promotion and dispensing of unapproved respiratory medications. CHASM, a coalition of patients, nurses, physicians and respiratory therapists dedicated to ensuring that patients with respiratory conditions have access to safe and effective medications, is calling for greater transparency from pharmacy manufacturers of compounded (mixed in a pharmacy) respiratory drugs.

"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," said Nancy Sander, President of Allergy & Asthma Network Mothers of Asthmatics (AANMA). "CHASM's Citizen Petition is a first step in demanding that the FDA take immediate action on this important issue."

"Pharmacies have a legal obligation to provide truthful and nonmisleading information about their products," explained drug safety consultant Sarah Sellers, PharmD, MPH. "The decision to use any medication must be based on the safety and effectiveness of the final product and this information must be fully disclosed. Alarmingly, millions of doses of compounded aqueous-based drugs for inhalation (CADIs) are mass-produced and dispensed without this essential information being provided to prescribers and patients."

CHASM's Citizen Petition seeks to ensure that compounding pharmacy manufacturers fulfill their obligation under the Food Drug and Cosmetic Act to disclose essential information to patients and prescribers in all CADI labeling and advertising so that patients and prescribers are aware of the potential risks.

  The petition specifically requests that the FDA:

   * Confirm that the law requires pharmacy businesses that promote or
     dispense CADIs to provide patients and healthcare professionals with
     information necessary to make informed decisions when using or
     prescribing these products;

   * Make the general public aware of this requirement to:

      * Ensure that patients and health care professionals know their rights
        to receive full disclosure of material facts;
      * Make compounding pharmacy businesses aware of their obligations to
        provide material facts; and
      * Ensure health care professionals have the material facts in order to
        advise patients about the risks or benefits of using CADIs.

   * Write a regulation that specifies how the material facts are to be
     displayed and worded in product labeling and in advertisements.

   * In some instances, require pharmacy businesses that have promoted or
     dispensed CADIs illegally to provide this information to patients who
     have already received the drugs and to health care professionals who
     have already dispensed the drugs.

"The mass production of unapproved drugs without basic information for prescribers and patients undermines one of the fundamental purposes of the Food, Drug, and Cosmetic Act. The Citizen Petition simply asks that the FDA take a number of reasonable steps to ensure that patients and physicians get the information that they need to make vital health care decisions," said David Adams, a partner with Venable LLP, and an expert in FDA law.

"It is terrifying that pharmacy manufacturers would knowingly expose U.S. children with asthma and fragile patients with chronic obstructive pulmonary disease (COPD) to possibly nonsterile and substandard drugs," concluded Sander. "We hope that with the submission of this Citizen Petition CHASM will force FDA to act on its responsibility to protect the millions of vulnerable patients with respiratory conditions who are exposed to these unapproved medications."

The Consumer Health Alliance for Safe Medication (CHASM) is a working group of patient and professional healthcare associations, convened by Allergy & Asthma Network of Mothers of Asthmatics (AANMA) to ensure patients with respiratory conditions have access to safe and effective medications and are protected from products that may pose unwarranted risks. These respiratory conditions include asthma, cystic fibrosis, pneumonia and chronic obstructive pulmonary diseases (COPD). To find out more, visit http://www.breatherville.org/ or call 1-800-878-4403.