Divergent Paths to Drug Regulation in the United States and the United Kingdom

Significant differences in the availability of new medicines in the United States and the United Kingdom became apparent in the 1970s. This article examines the history of drug regulation in the two countries and argues that the divergence was the result of distinctive regulatory approaches that emerged simultaneously throughout the twentieth century. The British approach was based largely on informal, nonstatutory controls, while the American approach relied heavily on centralized regulatory controls. The article argues that the nature of business-government relations has played a significant role in the divergence. The impact of these divergent approaches is apparent in the contemporary regulatory framework, especially with respect to determining the effectiveness of new drugs.

Certainly safety and efficacy must be established. But the determination of what is a satisfactory demonstration of efficacy is a matter of interpretation. Different regulatory agencies interpret that differently.

--Dr. L. H. Sarett, former president,
Pharmaceutical Manufacturers Association ¹

A Regulatory Divergence in the Availability of New Medicines

In the early 1970s, Dr. William Wardell conducted the initial and most well known comparisons of drug approvals in the United States and United Kingdom. ² He examined 180 drugs introduced during the period 1962-71 and concluded, "The overall British lead for mutually available drugs was, in terms of drug years of prior availability, double that of the U.S. In terms of exclusively available drugs, Britain had nearly four times as many as the U.S." ³ Wardell's results demonstrated a substantial regulatory divergence and it became evident that the United States was on the short end of an international "drug lag." ⁴ The primary implication was that the Food and Drug Administration (FDA) was functioning less effectively than the U.K.'s Medicines Division.

The regulatory policy literature has aptly demonstrated that regulatory policy is often formulated in response to major events or disasters (sometimes called "focusing events") that trigger reactions by policymakers and ultimately influence the direction of future policy. ⁵ This article argues that the regulation of new medicines in both the United States and United Kingdom has evolved largely in response to drug-related tragedies. Yet, the responses to such tragedies have not always been congruent, and regulatory policy has emerged quite differently in each polity. This incongruity has been conditioned by the nature of business-government relations, particularly with respect to the domestic pharmaceutical industry and the goals of the respective regulatory agencies. As a result, the historical divergence in American and British regulatory policy (and performance) presents an excellent opportunity for a comparative examination. I argue that differences in regulatory philosophy, consistent with what Vogel refers to as "national styles of regulation," ⁶ are primarily responsible for this divergent historical development. Vogel argued that the relationship between business and government was "the most striking difference" between Great Britain and the United States. The effect of such differences yields different "national styles" as industry representatives have enjoyed a close, cooperative relationship with British government officials, while the American regulatory process has been "highly legalistic and contentious." I shall argue that such "national styles" greatly contribute to the historical divergence in American and British medicine regulation.

Specifically, three primary differences in regulatory philosophy have emerged. First, there has long been a consensus in the United States on the importance of pre-market testing and regulatory activity. While this pre-market bias also occurs in the United Kingdom and throughout Europe, it has not been nearly as pronounced historically. Relatively speaking, European regulators have maintained a greater balance throughout the process on pre-, mid-, and post-marketing activities. ⁷ Second, the United States and United Kingdom have failed to establish a mutually agreeable standard for determining a given drug's effectiveness (i.e., efficacy). The FDA has codified the efficacy standard in the United States, while the British efficacy standard varies on a drug-by-drug basis. The...