DNAprint Genomics (DNAG)

[cosmiclifeform]

FDA to seek genetic information from drug makers
By Lisa Richwine, Reuters - Posted 10/29/2003 6:19 PM

WASHINGTON — U.S. health regulators will encourage drug makers to submit data on genetic differences that may predict how new medicines behave in different people, the head of the Food and Drug Administration said on Wednesday.

The FDA plans to issue guidelines on Monday explaining what type of information it would like to see from clinical trials regarding "pharmacogenomics," the study of how genes influence reactions to medicines.

Researchers are unsure why some people respond better to certain medicines or experience a serious side effect.

"We believe better analysis of pharmacogenomic data can close important information gaps," FDA commissioner Mark McClellan said during remarks to the Society for Women's Health Research.

"Developed properly, such information can make our regulatory process much more efficient and can help us better predict when an individual is likely to benefit from a particular medicine or from different doses," McClellan said.

Drug companies want the information developed because it can help them design clinical trials more efficiently and determine in advance which patients may react badly to a medicine, McClellan said.

In some cases, companies "don't want to submit the data to us because they don't know, and we don't know, what the results of these analyses really mean." Some firms are concerned the data "might raise a false red flag" that could slow down the FDA's review of a new medicine, he said.

The guidance will outline steps to address that concern while still allowing for the agency, outside experts and industry representatives to review the information, McClellan said.

The FDA also is working to develop a nationwide, electronic tracking system for side effects from drugs already on the market, McClellan said.

With such a system, "more timely and more complete, automatic information on risks associated with a particular treatment in a particular population would come to us a lot more quickly," he said.