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Expert Advice: Make Friends with FDA


As genomics-based discovery companies come closer to clinical trials and readying drugs for market, there’s increasing concern about FDA regulations. That’s why at a recent seminar hosted by Washington law firm King & Spalding people in the field stressed the importance of working with the FDA.

The agency is “no paper tiger,” says Mark Brown of King & Spalding’s FDA Practice Group. “It has enormous enforcement power, and can destroy companies and careers.”

Any genomics-based product intended for diagnosis or therapy falls under the FDA’s jurisdiction. “The genomics industry has been a subject of enormous scrutiny,” says Ed Basile, who heads up the FDA Practice Group.

FDA publications have described genomics as “one of the most exciting and highly publicized — and controversial — areas in biomedical research today,” Brown says. Partially because of its association with gene therapy, the entire field is regarded by the FDA as presenting unique health risks. The agency is particularly concerned about mutagenesis, germline modification, altered gene expression, and the inadvertent creation of infectious agents.

The FDA has already issued several specific documents regarding production, testing, quality control, and evaluation of gene therapy products, and these are expected to serve as models for regulation of genomics-based products in general. The agency has increased its inspections of biological product development, including reviews of investigators, IRBs, and sponsors, Brown says.

Faced with this stepped-up stringency, genomics executives are expressing concern about data auditing requirements extending further upstream than was previously typical early in the pre-clinical phase. The FDA has historically exercised authority over pre-clinical research by means of requirements for record-keeping, labeling, and good laboratory practice. However, many genomics-related developments have their origins in research using sequence and expression databases or tissue banks not under the control of the applicant.

“They’re not going to ask you to go further upstream than the technology permits,” says Christina Markus, an attorney who emphasizes the need to establish a dialogue with FDA early on. “That’s why it’s important to educate them.”

— Sherri Chasin Calvo

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