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Lester M. Crawford, Jr., D.V.M., Ph.D. - Association of Government Toxicologists

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Association of Government Toxicologists
Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,
October 3, 2002

Good evening. It's a pleasure to be here tonight, seeing many familiar faces and discussing a subject -- science -- that holds so much fascination for all of us that we never seem to get enough of it.

Speaking of myself -- my lifelong affair with veterinary medicine, food safety, toxicology, and other public health issues early this year brought me back to the Food and Drug Administration, an agency where I had worked during three periods in the 1970s and 1980s.

This time, I happened to take my post just in time to preside over the greatest expansion of the agency in more than 30 years. This is a project that was authorized by Congress after last year's terrorist attacks, in recognition of the fact that as the regulator of 80 percent of the national food supply and of all drugs, biologics and medical devices, the FDA was a major barrier against terrorism.

And so, in addition to the routine cares of the agency -- which include five product centers, one research institute, and 150 field offices that collectively keep an eye on one trillion dollars' worth of products -- there has been a crash effort to hire over 800 more people and to position the FDA on the front line of homeland security.

This ought to give you an idea what's my answer when people ask me how do I find working for the agency after a 20-year absence. I'm still looking for the right word. Is it "demanding?" "Absorbing?" It's certainly satisfying, and occasionally, it can even be fun. But it's always a challenge.

The FDA is a science-based agency whose agenda is largely set by whatever new public health hazard appears on our national screen -- the bioterrorism potential being the latest example. And since we're always on the cutting edge of the search for answers, that means that behind every accomplishment, behind every issue that seems to be resolved, there is a long queue of other questions -- some of them raised by the very solution just found -- that need to be probed.

In other words, the challenge is constant and great, and so is the workload. And since all of us in the scientific fraternity thrive on this steady diet of queries and riddles, I thought this would be a good occasion to give you a sample of the problems that we at the FDA see as in urgent need for scientific exploration.

As a matter of full disclosure, I should add that I hope that some of you might be tempted to come over to our agency and help us do the job. Here is a selection of our major toxicology issues:

  • Acrylamide in food
    (Neurotoxicant in humans, occupational exposure, rodent carcinogen, germ cell mutagen. Unknown bioavailability from food, limited data on in which foods and at what levels.)
  • Pathogen risk assessment
    (Vibrio, E. coli, others in food. Large data gaps: anthrax -- how many spores warrant treatment of people?)
  • Antimicrobial resistence
    (Action pending on fluoroquinolones for poultry; How do you predict performance of a new antimicrobial agent under use conditions? At what level of resistance a drug should be pulled off the market? How do we preserve drugs of last resort?)
  • Dioxins in food
    (How can we manage risk when environmental levels are decreasing. What else to do? How many scarce resources should be spent on surveillance? IOM committee reviewing to give us guidance.)
  • Mercury in seafood
    (Major issue: harm of methyl mercury vs nutritional importance of seafood with Hg. Public confused by different agencies (ATSOR, EPA, FDA) producing different "numbers." Key epidemiology studies present conflicting results?)
  • Safety of food from cloned and genetically modified animals
    (Herds of cloned dairy cows produce milk and meat we don't consume. Possible safety problems? IOM committee reviewing to give us guidance.)
  • Safety of bioengineered devices
    (E.g.: heart valves grown on inert scaffolding, using your own cells. How do we control angiogenesis so you have just the right amount of vascularization without resulting in a tumor?)
  • Food security
    (We lack in methods to detect agents, toxins, chemicals in food matrices and in capacity to screen extensively in case of an emergency.)
  • Ethyl mercury in vaccines
    (Important preservative in multiple dose vaccines; modest database to support safety assessment. Not as harmful as methyl mercury, but should be replaced wherever possible. Removed from most vaccines, remaining is at very low level; kids can get vaccines without it.)
  • Animal rule for drugs
    (Animal to human extrapolation is absolutely critical.)
  • Drugs for sub-populations
    (E.g., gleevec and herceptin: a new paradigm of combination drug/test approvals and the likelihood of more to come because of haplotype maps and markers for genetic basis of response.)
  • Post-market drug issues
    (E.g., rare acute hepatic failure still not understood.)
  • TSE/BSE and Chronic Wasting Disease
    (We can detect meat protein but we can't detect prions. If we had a case, how would we clean up? FDA is responsible for TSE/BSE control in biologic products and foods. CWD is spreading -- risk to cattle?)

Here are some other issues, which are not agent-driven:

  • Regulatory use of genomics data
    (EPA has issued a policy, but not the FDA. Case by case, supplemental data until we have experience and validation which will be a major problem: the technology continually changing)
  • Unnecessary use of primates for research
    (Need for new vaccines will likely increase use of primates. Is it the only model for developing and testing? Need alternative test models.)
  • Training of toxicologists to meet future needs
    (Increasing emphasis on biological rather than chemical issues, but most grants are for research on chemicals (eg, dioxins). Need experts in bioinformatics and computational modelling.)
  • Inconsistencies in risk assesssment procedures within and between agencies
    (Good news and bad news: new science pushes us to new and better approaches -- we're moving in the right direction -- but old regulations restrict change. E.g., Delaney clause (1958) still in effect.)
  • Obesity
    (Public health problem, major concern of the future. Can toxicology help find causes of the increase in prevalence? How do we get people to change behavior?)
  • Dietary supplements and neutraceuticals
    (Could we be more effective in regulating them? How to assess supplements' safety? IOM committee reviewing issue for our guidance.)

As I said, this is just a sample to give you idea of the breadth and variety of FDA's issues that are waiting for further research. The solutions could make a truly significant contribution to the national health, and I want those of you who are interested to consider yourself invited to join us at the FDA and try to make a mark by coming up with the badly needed answers. But first, I realize that you may have some questions of your own about the issues I mentioned. I'll be glad to give you my best answers.