August 16, 2002
Statement from FDA Deputy
- Three weeks ago, the FDA asked the Department of Justice to pursue a
criminal investigation of Metabolife - whether they made false statements to
FDA regarding the existence of adverse event reports.
Since at least 1997, the FDA has tried to get these adverse event reports
from industry. The FDA also unsuccessfully sought these reports through
litigation. Metabolife has refused and resisted us every step of the way.
Given their long history of being uncooperative, we view their offer to make
these reports available now to be disingenuous. We are greatly disturbed
that Metabolife has repeatedly refused to cooperate with the FDA, and news
that so many reports exist greatly heightens our concern.
Once we get these reports, the FDA will have a special task force review
Remember, Congress placed the burden on the Secretary of Health and Human
Services to prove that these products are unsafe. Thus, the Secretary called
for an extensive scientific review of ephedra in June to establish a
scientific base for addressing health concerns around ephedra. The Rand
Corporation is conducting a comprehensive review of the existing science on
ephedra, and the NIH will use this information to guide an expanded research
effort on the safety of the product.
Consumers may wish to consult their physicians before using this product."