New approval requirement for pancreatic drugs

FDA Consumer, July-August, 2004

Certain pancreatic drugs must get FDA approval by April 28, 2008, to remain on the market. The FDA decided to require approval of all pancreatic extract drug products (PEPs) as "new drugs" in April 2004 after reviewing data that showed substantial variations among such products now on the market. PEPs aid in the digestion of meals in people who have diseases affecting the function of the pancreas.

The FDA found that variations in formulation, dosage, and manufacturing processes affected the potency of the drugs, which could significantly affect their safety and effectiveness. "Variations in the potency of pancreatic extract drag products are unacceptable," says Dr. Lester M. Crawford, Acting FDA Commissioner. "If the label contains an inaccurate statement about a particular product's potency, then the patient is at risk for receiving too much or too little of the medicine."

PEPs have a long history of use, some preceding the enactment of the Federal Food, Drag, and Cosmetic Act, which requires FDA approval of new drugs. More than three dozen different PEPs are being marketed. Only one of these products has received formal FDA approval, but it is no longer being sold. The other products continue to be available because of their established use to treat serious conditions associated with the pancreas, including cystic fibrosis (CF) and chronic pancreatitis.

CF is a genetic disease that causes the body to produce thick mucus that obstructs the pancreas, preventing enzymes that help digest food from reaching the intestines. About 30,000 Americans are affected with CE according to the Cystic Fibrosis Foundation. About 14,000 to 28,000 Americans have pancreatitis, a disease that prevents the pancreas from producing enough enzymes to properly digest fat.

For more information, see www.fda.gov/cder/drug/infopage/ pancreatic_drugs.