FDA Review of Pancreatic Enzyme Products

In April 2004, a new rule was issued requiring makers of pancreatic enzyme products to get their drugs approved by the Food and Drug Administration (FDA) by April 28, 2010.

For enzymes to receive FDA approval, companies must test them in clinical trials in people with pancreatic diseases, which include cystic fibrosis (CF). These clinical trials confirm the safety and effectiveness of the enzymes.

The following will help answer questions you may have about the FDA’s rule and its possible effects on the enzymes you take.

Why did the FDA make this rule?

The goal of this rule is to make sure that pancreatic enzymes have the right amount of active ingredients to digest food. Inconsistencies in enzyme formulation can cause problems with digestion.

There are several types of enzymes on the market now, which vary in what they contain, how they are made and how many pills must be taken. It is difficult to know the exact amount of active ingredients in the different enzymes.

By conducting clinical trials and requiring FDA approval, the manufacturing process of pancreatic enzymes will be standardized, which ensures the consistency of the capsules from batch to batch. In addition, by having more precise information on these enzymes and how effective they are, doctors are better able to prescribe the right amount of enzymes.

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What if my or my child’s enzyme isn’t approved at this time?

As of April 28, 2010, if a maker has not received FDA approval, its enzyme product is no longer available. Your doctor may need to prescribe a different enzyme product for you. It is important to know that some enzyme makers may get FDA approval for their enzyme AFTER April 28, 2010. If you are concerned, talk to your CF doctor to discuss a plan of action.

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Will I still be able to buy the enzymes that my child or I take now?

The enzymes you or your child currently take should be available while supplies last during the FDA's review of these products.

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What happens if my insurance will not cover a different enzyme?

Once the FDA approves specific enzymes, insurance companies should continue to cover these products. To confirm what enzymes are specifically covered by your policy, please contact your health insurance provider.

Additionally, the CF Foundation’s Patient Assistance Resource Center (PARC) provides a variety of resources to help people with CF and their families manage their current health insurance coverage or find coverage to help them obtain essential drugs and treatments. For more information, contact the PARC at 1-888-315-4154 or email parc@cff.org.

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Why weren't enzymes approved by the FDA before?

Pancreatic enzymes, like a number of older medications, were first made before the FDA required them to be tested in clinical trials to see how well they work. As a result, the FDA allowed these medications to be prescribed and sold without FDA review and approval. The new FDA rule requires enzymes to meet the same standards of testing as any other new drug.

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Were clinical trials of pancreatic enzymes necessary?

Getting FDA approval for pancreatic enzymes is a step forward in improving the quality of care for people with CF. The CF Foundation has received reports of health problems in people with CF when an enzyme product was used that did not work as it should.

By requiring enzymes to be consistent in their formulation and to work properly, people with CF can be assured that they are getting the right amount of enzymes for their digestive and nutritional needs.

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How do I know which enzyme is best for my child or me?

The amount of enzymes needed for good nutrition varies from person to person. Your CF doctor will work with you to decide which enzyme is best for you or your child.

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Was the CF Foundation involved in the FDA’s decision?

The CF Foundation offered its expertise about CF and pancreatic enzyme products to the FDA. We shared our concerns about the variations and inconsistencies in the available pancreatic enzymes. We identified experts who could provide the FDA with more information about the importance of reliable and effective pancreatic enzymes for people with CF.

The CF Foundation supports the FDA’s decision because it will make enzymes better and help improve nutrition and digestion for people with CF. We will continue to offer our expertise to the FDA to ensure the best health for everyone with CF.

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Why is good nutrition important for people with CF?

Although enzymes help people with CF digest their food, there are still many people with CF who need more help with digestion. It is important that people with CF have the energy and fat stores to help fight infection and regain strength. Several studies have shown that good nutrition can have a positive impact on the health of the lungs and the body overall.

Without good nutrition, people with CF may not be able to stay as healthy as possible. Read "Nutrition: Pancreatic Enzyme Replacement in People With Cystic Fibrosis" for more information.

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Did the CF Foundation's focus on enzymes take away from efforts toward a cure?

No. The CF Foundation looks at all aspects of CF research and care to find a cure and help all people with CF lead full and productive lives. We take a broad and varied approach in the fight against CF to help ensure the success of our mission.

Today, for the first time in the history of the disease, there are therapies in the Foundation’s drug development pipeline that address the underlying cause of CF and hold the promise of significantly improving quality of life and life expectancy. More important, these therapies are unlocking the door to new research paths that could eventually lead to a cure for CF.

In the meantime, we continue to support research to help people with CF manage the symptoms and complications associated with the disease.

For more information, visit the FDA’s website.

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Updated: 7/24/2014