Person:

Carpenter, Daniel

We test several explanations for the commonly observed pattern that larger firms receive shorter FDA approval times for the drugs they submit. Candidate explanations include capture and rent-seeking and “external-signals” accounts. Analyses of 766 new molecular entities submitted to the FDA from 1979 to 2000 suggest that large-firm advantage in pharmaceutical regulation is primarily due to two factors: (1) enhanced regulator familiarity with large firms by virtue of their submission histories (an effect augmented when firms merge), and (2) regulatory favor for “early entrants” to a disease market, which is induced from disease-specific consumer pressure for approvals. Our analyses show that as much as 70% of observed large-firm advantage in expected FDA approval times can be attributed to these factors, 30-55% to familiarity alone. We find no consistent support for rent-seeking or “political clout” explanations.

OBJECTIVE: To determine the impact of FDA safety communications regarding the weight loss medications sibutramine and orlistat. METHODS: The 2008 to 2011 pharmacy claims data from CVS Caremark were used to determine the effect of the relevant FDA warnings on (1) use of sibutramine and orlistat, (2) their rates of discontinuation, and (3) substitution to an alternate weight loss medication in the 3-month period following discontinuation. RESULTS: The use of sibutramine, orlistat, or phentermine declined from 45 users per 100,000 Caremark enrollees in May 2008 to 24 users per 100,000 enrollees in December 2010. In the time series analyses of overall use of medications, a very small decline in the trend of use of sibutramine after the FDA communication (0.000002% per month decline after the communication; P < 0.001) was found. However, rates of discontinuation of sibutramine and orlistat were similar before and after relevant FDA communications (all P values >0.1 for both level and trend changes post-warning). Patients discontinuing sibutramine post-communication increased use of phentermine at a rate of 0.004% per month after discontinuation (P = 0.01). CONCLUSION: From 2008 to 2010, use of prescription weight loss medications was low and declined over time. FDA communications regarding the safety of these medications had limited effect on use.

The Physician Payments Sunshine Act (PPSA) promises a new era of transparency for the US health care system. Signed into law on March 23, 2010, the PPSA is part of the Patient Protection and Affordable Care Act of 2009.1 The PPSA requires medical product companies to report to the Department of Health and Human Services (DHHS) a range of “transfers of value” to covered recipients (physicians and teaching hospitals). With some exceptions, these transfers and their value will be publicly disclosed.

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history of bioequivalence, which emphasizes the shaping role of the state upon scientific processes, networks of regulators and scientists, and the centrality of transnational dynamics in the formation of drug regulatory standards.

This article examines the application of organizational reputation to public administration. Organizational reputation is defined as a set of beliefs about an organization’s capacities, intentions, history, and mission that are embedded in a network of multiple audiences. The authors assert that the way in which organizational reputations are formed and subsequently cultivated is fundamental to understanding the role of public administration in a democracy. A review of the basic assumptions and empirical work on organizational reputation in the public sector identifies a series of stylized facts that extends our understanding of the functioning of public agencies. In particular, the authors examine the relationship between organizational reputation and bureaucratic autonomy.

The aging of the global population, combined with changes in technology and cultural understandings of disease and the body, have thrust discussion and contestation over health into the center of local, national, and global politics. Is the politics of health different from the politics of other policy domains? On a number of dimensions, I conclude that it is. Voters and politicians in the developed world appear more likely to accept redistributive claims with respect to health than they are in other policy areas. Nations vary less widely in spending on health than on other functions of government and policy. Moral claims made about health are more likely to attach to its politics than are moral claims about the environment, labor, finance, and energy. More than these other realms, health politics encompasses issues regarding identity, the human body, and other personal matters that endow the health arena with greater significance. Bureaucratic agencies of state are more involved in the provision and regulation of health politics than in other areas, and the science-related nature of state expertise allows medical science itself to be sculpted in deeply political and administrative ways. The article concludes with reasons why political scientists should approach cross-policy generalizations cautiously, and with a call for greater engagement with health politics—to do for political science what health economics, the history of medicine, and medical sociology have done for other social science disciplines.