FDA gives pancreatic extract manufacturers up to 4 years to obtain NDA approvals
ROCKVILLE, MD., April 28, 2004 -- The FDA formally notified manufacturers of pancreatic insufficiency products that these drugs must get approval by FDA within the next four years in order to remain on the market.
FDA decided to require approval of new drug applications (NDAs) for all pancreatic extract drug products after reviewing data that showed substantial variations among currently marketed products. Specifically, the FDA review found that variations in the formulation, dosage, and manufacturing processes affected the potency -- in terms of both the products' activity and their release rates -- of the enzymes after patients take them.
The resulting variations in drug potency could significantly affect the safety and effectiveness of the drugs.
"Variations in the potency of pancreatic extract drug product are unacceptable. Patients with exocrine pancreatic insufficiency disorders rely on these drugs to provide the enzymes they need to digest food properly. 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," said Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs.
Steven Galson, M.D., Acting Director of FDA's Center for Drug Evaluation and Research, stated: "By requiring manufacturers to get approval for their pancreatic extract drug products, the FDA will be better able to ensure the safety and effectiveness of these products."
Pancreatic extract products have a long history of use, some preceding the Federal Food, Drug, and Cosmetic Act of 1938, and more than three dozen different products are being marketed. Only one such product has received formal FDA approval but it is no longer marketed.
The other products continue to be available because of their established use as replacement therapy to treat serious conditions associated with pancreatic insufficiency, including chronic pancreatitis and cystic fibrosis (CF).
CF is a genetic disease that causes the body to produce thick mucus that obstructs the pancreas, preventing enzymes from reaching the intestines that help digest food. According to the Cystic Fibrosis Foundation, approximately 30,000 people in the United States are affected with CF.
An added benefit of requiring FDA approval for pancreatic extract drug products is that the resulting standardization of the enzyme extract will lead to more accurate product labels, providing better information to patients and healthcare professionals.
FDA does not expect prices to change as a result of this notice. FDA's economic analysis of this action found that although some firms may choose to discontinue marketing, enough manufacturers would continue producing pancreatic enzyme products to keep the market competitive.
FDA's notice, on display at the Office of the Federal Register, covers pancreatic extract preparations containing pancreatin and pancrealipase. Both ingredients are extracted mainly from animal pancreata and contain principally amylase, protease and lipase. This action follows an April 24, 1995, Federal Register notice that put manufacturers of over-the-counter pancreatic extract products on notice that they must have FDA approval before marketing and that FDA will approve pancreatic extract products only as prescription medicines.
Accordingly, the FDA is also issuing a draft guidance for industry that, when finalized, will assist manufacturers of pancreatic extract preparations in preparing and submitting applications. Because children make up a significant portion of the target population for pancreatic extract drug products, the FDA is particularly interested in information regarding formulations and efficacy in children.
More information, including a list of "Questions and Answers"
about this action, is available on FDA's website at
Posted: April 2004