updated 4/27/2004 1:01:16 PM ET 2004-04-27T17:01:16

The makers of more than three dozen versions of pancreatic enzymes will have to formally seek Food and Drug Administration approval to stay on the market, the agency announced Tuesday.

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The enzymes are crucial for treatment of people with cystic fibrosis and certain other conditions, so the FDA is giving manufacturers four years to complete the necessary research and paperwork. Those that don’t would then have to quit selling.

The crackdown comes as part of the FDA’s efforts to re-examine very old drugs that began selling before the government ever required proof that medications worked well. The FDA has only formally approved one brand of pancreatic enzyme, and it is no longer sold.

Serious side effects possible
The issue: Studies show wide variation in how well different formulas of the enzymes work, and FDA has reports of some serious side effects connected to certain types.

So the agency told 23 manufacturers of enzymes containing the ingredients pancreatin and pancrelipase — extracted mainly from the pancreases of hogs — that to continue selling, they would have to file formal applications just like makers of brand-new drugs do.

Some will likely quit selling instead, and some may not win approval. But FDA said in a statement that it expects enough firms to comply that there will continue to be plenty of the enzymes for patients who need them, without much effect on price.

The FDA’s notice was focused on drug manufacturers. But products claiming to be various types of pancreatic enzymes also are sold by the loosely regulated dietary supplement industry. FDA spokesman Jason Brodsky refused to say what the agency’s action means for those products.

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