Pox_ An American History - Michael Willrich [115]
There were a few precedents for such state-level regulation. In the most ambitious effort, Pitfield’s grand tour of American vaccine farms for the Pennsylvania board in 1896 had demonstrated just how revealing on-site inspections could be. But the power of a state health board only reached so far; it could only use such information to control vaccine sold or produced within the state. The vaccine business was an interstate trade; the larger firms like Parke, Davis even manufactured and marketed their wares beyond the nation’s borders. An effective system of government regulation, many reform-minded physicians concluded, would have to be a federal government responsibility. Rosenau’s study of the vaccine market had shown the potential of that idea; in fact, Rosenau did not conceal his belief that the Marine-Hospital Service (with his laboratory) was the natural agency for the job.
On April 4, 1902, a bill was introduced simultaneously in the U.S. House and Senate, sponsored by the Medical Society of the District of Columbia, to create a new regime of federal regulation of biologics. The commissioners of the District drafted the bill, which received a strong endorsement from the District’s health officer, William C. Woodward. The District was not home to a single biologics manufacturer. But Woodward noted that there was “no legal reason why any person whosoever should not enter into the business at any time.” In the nation’s capital, as in most American states, no restrictions at all governed the production and traffic in biologics. Woodward explained that the “manner in which these substances are produced and marketed” made it impossible to efficiently control them by inspecting only the finished product. The nature of biologics production justified a more intrusive system of licensing and unannounced inspections of manufacturers.78
As if anyone needed reminding, Dr. George M. Kober, chairman of the D.C. Medical Society, advised Congress of the moral urgency of the biologics bill and its connection to the “unfortunate accidents” in St. Louis and Camden that had brought so much discredit upon antitoxin and vaccine. The social value of these lifesaving products—and the considerable risks that attended their manufacture and sale—demanded “that action be taken to preserve the confidence of the medical profession and of the community generally in them.” Like Woodward, Kober expressed dismay at the low barriers to entry in this industry of vital national importance: “Any kind of a stable, a little technical skill, and a fair amount of nerve are all that is needed.” Individual states were “powerless to protect themselves against impure and impotent materials,” especially since most of them consumed biologics made out-of-state. Testing a vial here or a package there was not enough; the whole industry required continuous government surveillance. “For these