Pox_ An American History - Michael Willrich [119]
On July 1, 1902, President Theodore Roosevelt signed the bill now known as the Biologics Control Act. Drafted by the District of Columbia Medical Society, the bill had been introduced by the Republican senator John Coit Spooner of Wisconsin. Although born of a great public controversy, the bill itself seems to have provoked little. Spooner’s papers contain little correspondence regarding the legislation, and both houses of Congress enacted it without debate. As The New York Times noted, “The bill . . . would involve a dangerous expansion of Federal authority were it not aimed to correct an evil yet more dangerous as directly and immediately affecting the public health.” The case for government regulation, the Times observed, “has been emphasized by recent experiences with virus and serums charged with tetanus germs and pus organisms.”91
Although the law originated in the District, its provisions reached the nation. Effective January 1, 1903, the law established a system of licensing and inspection for all biologics sold in interstate commerce or imported from abroad. Practically speaking, this meant that all substantial makers of vaccines, antitoxins, serums, and toxins in the United States would need to seek a federal license to continue to trade in biologics. The act empowered a federal board—composed of the surgeon generals of the Army, Navy, and Marine-Hospital Service—to promulgate regulations to be enforced by the Treasury Department. Unannounced inspections would be carried out at the discretion of the treasury secretary. The act also required manufacturers to plainly label each product with the maker’s address and license number and the date “beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results.” Penalties included suspension of the license, a maximum fine of $500, and up to one year’s imprisonment.92
On the same day, Congress passed another law that enlarged the authority of the Marine-Hospital Service and gave it a commensurately bigger name: the U.S. Public Health and Marine-Hospital Service. Service medical officers would serve as the frontline inspectors of the new biologics licensing regime, and Milton Rosenau’s Hygienic Laboratory would administer the act. The federal biologics board promulgated its first regulations in February 1903; they became effective that August. To receive a license, makers had to submit to an inspection by a medical officer from the Service. Licenses were good for just one year and could be reissued only after another inspection. If an inspector turned up any problems—bad production standards, impure or impotent products—the government could suspend a maker’s license for thirty days; if the maker did not correct the problem, the government could revoke its license. Parke, Davis received license no. 1; H. K. Mulford no. 2; and H. M. Alexander no. 3. By 1904, the government had inspected and licensed thirteen biologics establishments, mostly for the manufacture and sale of diphtheria antitoxin and smallpox vaccine. Forty-one companies would hold licenses by 1921; all told, those companies marketed more than a hundred different biological products.93
The new law had an immediate impact on the biologics industry. The government refused to license some shoddy makers and suspended the licenses of others. Some smaller companies simply shut down, knowing they could not afford to meet the new standards. In the first few years of the new regime, Mulford’s Pennsylvania rival H. M. Alexander had its license suspended and was twice ordered to remove tainted products from the market. In 1908 and 1909, Mulford and Parke, Davis had their licenses suspended when hoof and mouth disease broke out among their antitoxin horses and vaccine