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Lester M. Crawford, Jr., D.V.M., Ph.D. - CBER/FDA/NIH Symposium


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.

CBER/FDA/NIH Symposium
on 100 years of the Biologics Control Act

Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,
September 23, 2002

Good morning, and my congratulations to the producer of the video we've just seen. It shows very effectively the enormous public health benefits that can be achieved when we place new knowledge on the front lines of the ancient crusade against disease and pain by translating scientific progress into effective regulations.

What I find very interesting about the Biologics Control Act of 1902 is its practically friction-free history: here is a major act that was passed by Congress without a debate, and then retained its essential shape for 100 years. This is a rare legislative record that leads to two conclusions: One, that the bill was well drafted, and the need for it was undisputable -- which it certainly was, considering the children who died in 1901 from a contaminated antitoxin; and two, that, above all, the implementation of the act has been so strikingly successful there has been no need to change it.

And so while we salute today the 57th Congress for having adopted this outstanding legislation, as regulators and scientists, we are gathered here to pay homage to the men and women of great talent and dedication who have instilled the act's provisions with real life and meaning -- and to pledge to keep their tradition alive.

The honor roll of biologists and regulators who've made the Biologics Control Act into a major shield protecting the public health is far too long to be cited in full, but there are several names that represent the progress of the last 100 years.

The list starts with Joseph Kinyoun, a Marine Health Service officer who in 1887 established Hygienic Laboratory, which was one of our country's earliest facilities for bacteriological research. In addition to pioneering medical laboratory research of the U.S. Public Health Service, Kinyoun was among the first government scientists to demand the testing of all serum intended for sale, and to call for the establishment of regulatory service.

Kinyoun's successor, Milton Rosenau, expanded the Hygienic Laboratory into a research organization so competently staffed and effective that by 1907 it established standards and issued licenses for the manufacture of smallpox and rabies vaccines, diphtheria and tetanus antitoxins, and several antibacterial serums.

Closer to our time, we owe a tribute Edwin Joseph Cohn, an eminent chemist whose life-long study of proteins at the start of World War II culminated in the development of fractionation, and the manufacture of safe plasma derivatives. It was an accomplishment that saved the lives of untold numbers of wounded GIs who received a blood transfusion.

Also during the 1940s, brilliant research by Dr. Margaret Pittman of the Division of Biologics' Control of the National Institutes of Health led to the development of the first effective antiserum for invasive H. influezae type b disease. Dr. Pittman went on to develop a potency assay for a pertussis vaccine and, together with her colleague Thomas Probey, provided the scientific basis for production techniques that have given us pyrogen-free blood products.

During the same 1940s, three other scientists of the NIH Division of Biologics' Control -- John Oliphant, Alexander Gilliam, and Carl Larson -- demonstrated that hepatitis was caused by a virus that was heat resistant, a discovery that led regulations requiring irradiation of human plasma and serum. From World War II on, most of the great names in biology have earned the world's esteem and a towering standing in medical history. The eradication of polio will be forever associated with the splendid accomplishments in the 1950s and 1960s of Jonas Salk and Albert Sabin, and Paul Parkman and Harry Meyer will always be remembered as the developers of the rubella vaccine, which was a major landmark of the late 1960s. There is little, if anything, that we can add to the universal accolades that have honored these distinguished scientists.

But what we can and must do today is acknowledge the contribution to mankind's quest for a long and healthy life that has been made by the thousands of biologists, chemists and regulators whose names do not appear in textbooks, but who in the last 100 years have played a vital role in supporting and advancing the landmark accomplishments of their more prominent colleagues.

I am thinking about the women and men who helped establish the first biological standards in Milton Rosenau's Hygienic Laboratory, and who used Margaret Pittman's findings to license vaccine for H. influenzae type b.

I am thinking about the researchers who helped conduct the studies of Salk and Sabin, and the scientists who developed the polio vaccines' safety tests to assure their widespread use. I am thinking about our colleagues, some of whom are in this room, whose work was essential for the approval of the first recombinant DNA vaccine for Hepatitis B.

I am thinking about the scientists who are strengthening the front lines of our war against terrorism by developing vaccines against small pox, anthrax, and other potential weapons of mass terror.

And I am thinking about the biologists and regulators who are grappling with the scientific, legal, and moral questions that have been raised by the mapping of the genome -- questions that already proliferate in the new fields of gene therapy, xenotransplantation, and proteomics, and that persist in such urgent projects as the development of vaccine for HIV.

Many of these questions have no precedent -- and many of the answers that will emerge from studies and laboratory work will have an impact on biology research and its public acceptance and support as profound as any of the pioneering accomplishments of the last 100 years.

As scientists and regulators who've been privileged to continue on the path that spans the great distance from the first licensed vaccine to the latest test kit for HIV, we are deeply committed to the tradition handed down by our famous, as well as unheralded, predecessors. It is thanks to the right directions they chose, the high standards they set, and the exhaustive efforts they made, that today, we can see so far into the future.

On this occasion, which marks the beginning of the second 100 years of the Biologics Control Act, let us pledge to stay true to the ideals of act's first century: let us keep moving biological science and science-based regulations forward, toward our ultimate goal of better life for all.