AARC Asks FDA to Keep COMBIVENT on Essential Use List

April 11, 2007

The AARC is supporting a Citizen’s Petition aimed at keeping the chlorofluorocarbon (CFC) containing COMBIVENT inhaler on the market until a CFC-free substitute can be developed.

In a letter sent to the Food and Drug Administration (FDA) on March 28, AARC President Toni Rodriguez, EdD, RRT, outlined the problems that will occur should COMBIVENT be withdrawn before a suitable substitute is available. Specifically, patients will be forced to acquire separate prescriptions for the two active ingredients in COMBIVENT, ipratropium bromide and albuterol sulfate, thus incurring additional co-pays and complicating their medication regimen.

Studies have shown, for example, that patients are more likely to comply with their plan of care if they are given two drugs in a single inhaler than if they have to take each drug separately using two different delivery devices. With improved compliance comes improved outcomes for pulmonary patients taking these medications.

While noting the AARC’s full support of the Montreal Protocols, which call for the phasing out of all CFC-containing products, in the case of COMBIVENT Dr. Rodriguez strongly urged the FDA to follow stated policy calling for CFC products to remain on the market until a CFC-free substitute is available.

“We do not accept the premise that requiring patients to obtain two prescriptions, and perhaps making two co-payments to purchase, and use, two different delivery devices containing one medication each, is indeed a substitute for a combination of two medications delivered with one prescription, and one delivery device,” she writes. “This is not in keeping with the intent of the substitution clause.”