FDA is Requiring Approval of Enzymes by 2008

[anonymous]

I just learned this last night - something this big should have received more publicity.

It was announced this past April that all pancreatic enzyme manufacturers must seek approval and get approval for their enzyme products by the FDA by April of 2008 in order to continue to be sold in the US. If they don't get or seek approval they can no longer be sold here. This charge was led by The CF Foundation along with Leslie Hendeles, Pharm. D., professor of pharmacy and pediatrics at the University of Florida.

The CF Foundation and the FDA say if the enzymes you use are not approved you can use one that is. It is our experience that we cannot change the enzyme our son is on - his body just doesn't seem to adapt.

Exatcly who are they looking out for?

 

[anonymous]

I thought most enzymes were approved already. Other wise you would have to buy them like a natural supplement? But I don't know I am not schooled in things aproved. This still doesn't make sense to me. Stopping the sell of enzymes because of fda approval would be like stopping the sell of insulin. To many people rely on it to stop making or selling it, not just cfers. But I could have sworn they were already approved. maybe is generic kind thats not? or just certain ones? Anyone else hear anything about this
Amanda

 

[arabeth]

This does effect both brand name and generic enzymes....they currently do not need FDA approval...Read about it at the following site:

http://rx4cf.org/whitepapers.html

 

[arabeth]

Here is the story from the site I posted earlier, just to save you the time of going back and forth...I don't know anything about the dates as to when any of this has to be done...I did not see anything about that here...


ILLEGAL GENERIC PANCREATIC ENZYMES


Leslie Hendeles, Pharm.D.

Professor, Pharmacy and Pediatrics

University of Florida*

Current Problem

Several generic drug companies (e.g. Eurand, Mutual, KV) have begun manufacturing and distributing microencapsulated pancreatic enzyme products. Wholesalers are stocking these products and at least one chain has designated the Mutual product as the preferred brand for their pharmacists to dispense. Consequently, pharmacists have begun substituting these products for Creon, Pancrease MT and Ultrase. According to FDA’s Office of Generic Drugs, none of these companies have received FDA approval to sell these products. FDA’s final rule, published on April 25, 1995, declared that exocrine pancreatic insufficiency drug products, whether marketed on an OTC or prescription basis, are new drugs for which approved applications are required for marketing.(1) Such applications require efficacy or bioequivalence studies and it is unknown whether these products have been tested in humans.




Background

Because pancreatic enzymes were available before the passage of the 1938 Federal Food, Drug and Cosmetic Act, they were exempt from FDA regulation.(2) Even the newer microencapsulated formulations were marketed without FDA approval.(2) They contain a different amount of enzymes than what is stated on their labels; they differ in ability to resist inactivation by stomach acid; and the pH required for release of enzymes differs between products.(3)


Because of reports of treatment failures in patients with cystic fibrosis after pharmacists substituted generic products for Pancrease(4) and the association of fibrosing colonopathy with high daily doses,(5) FDA initiated the process to require firms to obtain an approved application to market their products.


Since pancreatic enzymes are life-sustaining for patients with cystic fibrosis, the FDA allowed all brands that were on the market on April 25, 1995 to continue to be sold while the new drug application process was being completed. Implicit in such a regulatory action is that no new products can be marketed without FDA approval. Since the generic products were recently introduced, after FDA’s final rule was issued, they violate the intent of the agency’s Federal Register notice and as new products without an approved application are subject to regulatory action.


FDA’s Office of Compliance has been notified about the illegal products but it will take some time before they are removed from the market place. This process is likely to speed up, however, if there are reports of patients being harmed by illegal generics.

Recommendations

1. Pharmacists should not substitute a generic for a brand name pancreatic enzyme until such time that FDA approved bioequivalent generic products become available.


2. Forward a copy of this memo to prescription benefit plans who insist that the patient must have a generic product. It is unlikely that they will continue to insist on the dispensing of an illegal product.


3. Report any treatment failures to the FDA Medical Product Reporting Program (MedWatch): www.fda.gov/medwatch/report/hcp.htm; fax: 800-FDA-0178 or by phone: 800-FDA-1088.

 

[allie1]

I am so happy you posted this article. I'm in the middle of trying to get my daughter's enzymes at a cheaper copay through my insurance company and I think this will help a lot. Right now they are charging me the highest copay b/c they say "Well, there is a generic form available so you should be getting that one instead of the brand name" and of course, we have been told not to ever use the generic form.

Thank you <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[AbsintheSorrow]

Insurance companies are assbites. I've heard many times that the generic enzymes don't work worth a damn.

 

[arabeth]

It just happens that I work for one of the largest of those assbites in the country... ... and I totally agree that they can be assbites....lol... Fight them tooth and nail over the copay issue. The generic enzymes are being sold illegally according to this article and if they are illegal the insurance companies shouldn't be allowing them to be covered at all. And if there is no legal generic available they shouldn't be punishing you for it. (thou many times they do...) fight the good fight thou. They will not bend over for you, you have to knock them over.

Good Luck!!!

 

[arabeth]

Hey...me again... I found the FDA aritcle that says that the enzymes will require FDA approval by 2008... If you are interested, you can read it here:

http://www.fda.gov/bbs/topics/news/2004/NEW01058.html

I sure hope they all get the approval needed by then...I know I don't want to have to switch my daughter's enzymes...Creon are the only ones that seem to really work well for them.

 

[anonymous]

Hi - The FDA order says that the Cystic Fibrosis Foundation (the one who pushed for this in the first place) was suppose to notify the cf clinics and the patients. No one I have spoken to yet; neither the CF clinic or manufacturer of the enzymes my son uses knows about this. Further, unless they are on the fast track with the FDA for approval - they won't be for sale in the U.S.

We tried to switch my son to another - stronger dose so he would be able to take fewer pills. He is one of the ones who cannot switch. What do we do if they are not available?

 

[ladybug]

Have ya'll tried getting meds through CFServices Pharmacy? (cfservicespharmacy.com) They may be better able to tell the insurance companies that generics are not good to use.... They have Creon, Ultrase, Pancrease, etc. That is where I get alot of my meds. They are only a pharmacy for CFers and I think they only carry name brands of the things we use. (As long as your insurance is one of their providers-they have many, I would go with them and then can't you just tell the insurance co. that the pharmacy you use doesn't have generic???) Good luck!

<img src="i/expressions/sun.gif" border="0">