Mark McClellan, FDA commissioner, on antibioterror initiative
By Globe Staff, 3/23/2003
President Bush's proposal to expand the nation's medical arsenal against bioterrorism gives
the Food and Drug Administration a mandate to speed the approval of medical defenses
against such threats as anthrax, smallpox, plague, and botulism. FDA Commissioner Mark
McClellan, in Boston last week for a Harvard-MIT Division of Health Sciences and
Technology forum, ranks counterterrorism as one of the public health agency's top priorities.
Q. What can the FDA do to shave time off the drug development process, which including lab,
animal and human studies takes years, without lowering standards for safety and effectiveness?
A. We've added about 100 new personnel in the past year-and-a-half to work on issues related to
development of medical counterterrorism measures. We are devoting more effort and more staff
time to this activity. Critical to this effort is very close collaboration and consultation with companies
to make sure they can meet our standards as quickly and effectively as possible. We ca n help them
identify the effectiveness tests that need to be done, conduct those tests as quickly as possible, and
once effectiveness has been demonstrated, get their manufacturing processes up to speed. We also
need more earnest innovation in the areas of bioterrorism, chemical terrorism, and radiologic
terrorism. That's why the FDA has been very supportive of the president's [Operation] Bioshield
proposal. Among other things, it would provide new and much needed financial reward for product
developers that actually produce and deliver safer, more effective next generation treatments for
agents of terrorism.
Q. How long do you think it will be before some of these new vaccines are available?
A. I think products could show up within months to a year. We've already worked to identify the
most promising and potentially quickly available treatments. These include vaccines for smallpox
that have fewer side effects so they can be used in people with weakened immune systems. They
include better antitoxins for botulinum toxin. They include a potentially more effective vaccine for
anthrax. These are all products where the concept is clear and what's needed is a mechanism that
will give companies the incentive to make investments in clinical testing and production.
Q. Would other products, such as blood substitutes or wound healing products, that have military
or national defense uses also qualify for expedited review?
A. Bioshield includes not only vaccines, but also new drugs, new biologics that could potentially
treat a range of agents of terrorism - not just bioterrorism but also chemical agents, nerve agents,
and radiation attacks. But the definition for Bioshield requires that the product not have a
commercial application separate from terrorism. In other words, if there is a potential market as
there might be for blood substitutes in emergency rooms for the treatment of injuries sustained here,
then it would not qualify. That's not to say we wouldn't take steps to speed the development of
those treatments.
Q. What's available now in case of a bioterrorist attack?
A. We've been working around the clock to get an approved smallpox vaccine available in
quantities that could serve the entire US population. We now have enough diluted Dryvax in our
national pharmaceutical stockpile to vaccinate the whole population if need be. We're also working
closely with Acambis on their new smallpox vaccine. One of the challenges is that the clinical testing
process for these agents of terrorism has to be different. We're using new regulations and
approaches to get these treatments approved as quickly as possible.
This story ran on page C1 of the Boston Globe on 3/23/2003. |
