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Emerging Sciences Discussed at FDA Forum

Donna Young

Pharmacogenomics, the study of how genetic differences influence the variability in patients’ response to drugs, is one of the most promising opportunities for improving technology development and the drug approval process, said FDA Commissioner Mark B. McClellan.

"There is a tremendous amount of information emerging" in genomics-related activities, he said, adding that FDA must discover what that information means to drug development and clinical care. McClellan

McClellan’s comments were made at a special press briefing during FDA’s 2003 Science Forum held April 24–25 in Washington, D.C.

About 2,000 people, including 1,000 FDA scientists, gathered at the two-day event to discuss bioinformatics, microbial threats, cancer risks, toxicology issues, and public health initiatives in a post-September 11, 2001, environment.

"It is incumbent on [FDA] to facilitate better development" of pharmacogenomics, McClellan said.

Pharmacogenomics was one of the central issues examined by FDA’s Science Board at an April 9 meeting, he noted. The topic was also considered at an April 22–23 meeting held by the agency’s clinical pharmacology subcommittee.

FDA’s regulatory role regarding pharmacogenomics has not yet been defined, McClellan said.

"At this point, we don’t know what the practical implications of [pharmacogenomics] are for clinical care and patient outcomes," he added.

But, he said, if pharmaceutical companies wish to include pharmacogenomic information in new drug applications, FDA would "encourage them to do so and we will evaluate that as part of their application."

FDA’s mission is more challenging than ever before, with concerns about terrorism, the development of more complex medical products, and emerging sciences such as genomics, McClellan said.

Department of Health and Human Services Secretary Tommy G. Thompson, speaking at the Science Forum’s opening session, praised FDA’s recent proposals to require machine-readable codes on drug and biological product packaging and to revise its adverse-events-reporting requirements.Thompson

"Grocery stores are more technologically advanced than most hospitals," Thompson declared. "No wonder there are mistakes."

FDA has a vast array of research projects underway, McClellan said, including the development of diagnostic tools to identify severe acute respiratory syndrome (SARS) in patients and SARS treatments and vaccines.

FDA scientists are also involved in forensic chemistry studies that will aid in identifying counterfeit drug products, he added.

FDA is collaborating with the National Library of Medicine to develop the DailyMed, an electronic database that would provide up-to-date medication information, including labeling changes, to health care providers, McClellan noted.

One hot topic before FDA is what the agency plans to do about ephedra.

FDA announced February 28 that it would reopen for 30 days the comment period for a rule it proposed in June 1997 that would require the label of any dietary supplement containing ephedrine alkaloid, the active ingredient in ephedra, to bear a warning statement.

FDA’s latest proposed warning label for dietary supplements containing ephedrine alkaloid states "Heart attack, stroke, seizure, and death have been reported after consumption of ephedrine alkaloid."

McClellan said FDA was prompted to reopen the comment period after reviewing a Rand Corp. study in which researchers found an increased health risk associated with ephedra use.

The agency received 14,000 comments about FDA’s proposal regarding ephedra, McClellan said.

"They ranged from ‘Leave my ephedra alone’ to ‘I can’t believe that you are leaving this on the market,’" he said.

McClellan said he considered about 2,000 of the comments to be "substantive."

FDA is being "very careful to be in compliance" with laws that affect dietary supplements, he said, adding that the agency plans to make an announcement about its proposal concerning ephedra "very soon."