Congress Takes Action

The limited powers of the FDA had been graphically demonstrated during the Dalkon Shield controversy. Congress not only was aware of the publicity concerning harmful devices but also had held hearings on several products during this period.^[21]

Pacemaker hearings, medical device (IUD) hearings.

Bills to expand the FDA's authority over devices had been introduced every year from 1969 to 1975. The likelihood of congressional action was increased by the fact that consumer activism was at its peak. The controversies surrounding IUDs mobilized the nascent women's movement, and defective cardiac pacemakers caused concern among the elderly. Ralph Nader's Health Research Group vigorously lobbied government to protect consumers in the areas of medicine and health products.

On the other side, the medical device industry was not well organized. Until this time, government had been either neutral or a benefactor, not a threat to the industry's well-being. In fact, there was no trade association until the mid-1970s. Unlike the drug industry, which was represented by the old and powerful Pharmaceutical Manufacturers Association (PMA), the device producers were a disparate group with no clearly identifiable or shared issues. Many were small innovators with little or no experience with the political process.

The prospect of regulation spurred organizing efforts. The Health Industry Manufacturers Association (HIMA) formed in 1976, but it was too late to stop Congress from regulating the industry. Indeed, the organization was established in direct response to the new regulatory threat. Some larger device companies had their own Washington offices that handled government relations; for smaller companies, HIMA was the only representation. HIMA has since become larger and more active, but in the 1970s members of the industry were reactive, not proactive. Regulation was only a matter of time.

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