According to the FDA, there are 23 manufacturers and 26 repackers marketing 38 enzyme formulations. To streamline the approval process, the FDA has published a guidance document that will assist manufacturers of pancreatic enzyme preparations with drafting and submitting applications for approval of their products. Until FDA approval has been secured, patients will continue to have access to their traditional enzymes as long as they remain on the market, thereby preventing a sudden change to a delicate healthcare regimen.

"This decision by the FDA is a victory for the CF Foundation and for all people with CF. Prescribing enzymes should not have to be a 'guessing game' for patients, doctors or pharmacists," said Robert J. Beall, Ph.D., president and CEO of the CF Foundation. "Patients should be able to rest assured that their medication is the right dosage for them and that it will bolster their health, not hinder it. We applaud the FDA for this mandate and hope that all pancreatic enzyme manufacturers will take action immediately to obtain FDA approval to establish the consistency and dosage of their products."

Until all manufacturers have acquired FDA approval, pharmacists should be aware of the production variances, the allowable limits in product content and the inequality of certain pancrelipase products. Additionally, pharmacists should not provide a substitute pancreatic enzyme without first contacting the prescriber, until FDA-approved bioequivalent generic products become available.

CF is a genetic disease that affects approximately 30,000 people in the United States.  A defective gene causes the body to produce abnormally thick, sticky mucus that leads to chronic and life-threatening lung infections and impairs digestion.  When the CF Foundation was created in 1955, few children lived to attend elementary school.  Today, because of research and care supported by the CF Foundation with money raised through donations from individuals, corporations and foundations, the median age of survival for people with CF is in the early 30s.