Without pancreatic enzyme replacement products, malnutrition and osteoporosis are common.
In April 2004, the Food and Drug Administration (FDA) issued a new rule requiring makers of pancreatic enzyme products (PEPs) to get their drugs approved by April 28, 2010.
Unapproved pancreatic enzyme products had been available for many years, but after that cut-off date, makers of pancreatic enzyme products were required to stop manufacturing and distributing unapproved products.
This new regulatory requirement is designed to confirm and assure the safety, effectiveness, and consistency of PEPs, but an unintended consequence has been a steep increase in the average cost of medication per prescription.
For individuals with exocrine pancreatic insufficiency, a condition most frequently encountered in patients with cystic fibrosis or chronic pancreatitis, medication with pancreatic enzyme products (PEPs) is a lifelong regime, typically requiring three to four daily doses.
These digestive enzymes are used to improve food digestion in patients whose bodies do not produce enough pancreatic enzymes.
In addition to cystic fibrosis, PEPs have been used to treat patients with various other pancreatic disorders, including Shwachman-Diamond syndrome, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.As patients get older and their food intake increases they need to take higher doses of pancreatic enzymes. However, critics contend that the approval process for PEPs has been slow.Although PEPs have been used for several decades, they had been marketed in the U. Prior to the regulatory change, some 30 PEPs had been available on the market.Currently, only six are approved, and the average cost per prescription of PEP therapy has more than doubled.And while cystic fibrosis patients often carry insurance coverage for prescription medication, some do not, and that is more frequently the case for patients with other disorders for which PEPs are indicated such as chronic pancreatitis. Smith in the April 2014 edition of Gastroenterology & Endoscopy News cites Dr. Gardner, MD, Director, Pancreatic Disorders and Assistant Professor of Medicine at the Geisel School of Medicine, Dartmouth–Hitchcock Medical Center, in Lebanon, New Hampshire, who presented research on PEPs at the 2013 American College of Gastroenterology Annual Scientific Meeting. Gardner notes that until about seven years ago, there were around 30 different prescription-based formulations for pancreatic enzyme therapy available because prior to the FDA’s establishment in 1938, these enzyme products were already in place; “grandfathered in” as it were, and previously not required to undergo FDA New Drug Application (NDA) approval. Smith reports that in order to determine the effect of the FDA’s new approval requirement on the cost of and access to PEPs, Dr. Gordon consulted the IMS Health Product Report Database, which tracks total prescriptions and total sales of individual drugs. the total sales for nongeneric pancreatic enzyme replacement products were 1 million before this was put in place.“Our primary outcome was the cost of prescriptions one year before and one year after the FDA NDA requirement was put into place,” Dr. In 2012, [the year] for which the most recent data is available, it was up to 2 million.” Dr.