FDA raises concerns over anthrax medikits
At a meeting of the FDA and a panel of scientists and academics, regulators said that distributing the medikits could lead to misuse of the medications inside and may serve to stir public fears of a biological attack, according to Bloomberg.
"People may infer an anthrax attack is imminent," Thomas Moore, the chairman of an FDA advisory committee, said, Bloomberg reports.
The medikits would contain a 10 day supply of doxycycline, an antibiotic that was hoarded after the September 11, 2001, terrorist attacks. Some experts have called for the kits to be available for all Americans to store in their homes.
The Biomedical Advanced Research and Development Authority, a branch of the U.S. Department of Health and Human Services, said that it would like to see 10 million of the kits distributed to first responders and their families before expanding a program to include the rest of the population.
BARDA would need FDA backing before a rollout date for the kits could be set. It would also need to partner with a pharmaceutical company to guide the medikit through the regulatory process. Currently, companies that make versions of doxycycline include Pfizer and Impax Laboratories.
"The public just looks at the system as there you go again crying wolf," Diane Cappelletty, a pharmacy professor at the University of Toledo College of Pharmacy, said, Bloomberg reports.
Some advisors warned that consumers could misuse the medication inside the kits, which could lead to an increase in antibiotic resistance. A 2007 test of similar kits in St. Louis showed some evidence of the potential for misuse. One person took doxycycline when an emergency was declared during a snowstorm. Others took the medication for minor ailments.
"I can't help but be reminded of the decades old fallout shelter craze," Marcus Reidenberg, a professor of public health at Weill Cornell Medical College, said, Bloomberg reports. "It's assuming that everyone in the U.S. knows we have doxycycline and no one in any organization that might want to attack the U.S. doesn't."