- The Washington Times - Thursday, April 23, 2009

ANALYSIS/OPINION:

A French drugmaker selling raw botulinum toxin to Iran wants approval from the Food and Drug Administration to peddle its products in America. Does anyone think this is a good idea?

French pharmaceutical company Ipsen has been providing raw botulinum toxin to the University of Tehran and the Pasteur Institute of Iran ostensibly for medical-research purposes. Botulinum is one of the most lethal biological agents in the world. Under certain circumstances, a single gram can kill more than a million people. Because botulinum is such a potentially devastating bioweapons agent, its use and handling is strictly regulated under U.S. law.

Ipsen is seeking the FDA nod to market two botulinum-based products in the United States: the cosmetic Reloxin, which is similar to Botox, and Dysport, which is used for treating conditions such as muscle spasms. A potential regulatory loophole could prevent the FDA from using the risk of bioterrorism as a criterion in determining whether Ipsen will be given access to the U.S. market. The FDA generally judges drugs by medical criteria and does not make judgments on their broader national-security implications. Additional factors need to be considered. A company that is potentially enabling Iran to develop biological weapons should not be rewarded with access to America’s large consumer market.

The biological-weapons threat is serious and growing. The December 2008 Graham-Talent Commission Report on the Prevention of WMD Proliferation and Terrorism noted the particular issue of dual-use technologies enabling bioweapons programs. It warned that such programs “can be hidden in seemingly legitimate scientific and industrial organizations.” Based on the findings of this report, President George W. Bush issued an executive order in January 2009 forming an interagency working group to examine strengthening the biosecurity of the United States. Still greater attention must be paid to the international implications of the toxin trade.

Members of Congress have tried to bring attention to the issue. In September, House Foreign Affairs Committee Chairman Howard L. Berman, California Democrat, and Terrorism Subcommittee Vice Chairman David Scott, Georgia Democrat, requested the acting comptroller general to investigate U.S. exports to Iran, asking in particular whether the government has authority to prohibit access to the United States “if a foreign-based company were doing business in Iran that contributes to Iran’s biological weapons program.” In October, Rep. Darrell Issa, California Republican, and House Minority Whip Eric Cantor, Virginia Republican, sent a letter to the chairmen and ranking members of a number of committees expressing their concerns about Ipsen’s ties to Iran.

On March 17, legislation was introduced to prevent the FDA from processing a biologics-license application for any company that, among other things, “marketed, sold or distributed that product in the Islamic Republic of Iran” or had “been the subject of an investigation … for potential violations of the Iran Sanctions Act of 1996.” This bill clearly targets Ipsen. We suggest that foreign companies be offered a simple bargain that makes the linkage clear: Cease providing Iran with raw botulinum and other dual-use bioagents, or be banned from selling your products in the United States.

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