The relaxation of regulation in pharmaceuticals has been linked to an increasing role of regulatory agencies as facilitators of innovation as opposed to simply gate-keepers. The US Food and Drug Administration has been at the debate since the beginning. A recent paper by Stuart Hogarth (drawing on the work of Williams et.al, 2011) highlights the recent ‘innovative’ turn of the US FDA, its vision of a genomic future for pharmaceutical Research and Development in the USA and the wider neoliberal policy agenda of permissive regulation.
There have been many differing opinions on the way that the US’s pharmaceutical policy has become more neoliberal in character. On the one hand Abraham and Davis (2013) argue that there has been an emergence of ‘corporate bias theory’ in which reforms calling for less stringent regulations are pursued under the belief that patients and industry both seek less regulations and faster drug discovery processes. In contrast, Carpenter (2011) takes a pluralist perspective focussing on the impact of proposed reforms on the 'interests' of a wider group of actors ranging from specialist interest groups, civic organisations, media syndicates, corporations and wider society. As reputation management is crucial to the organisational behaviour of regulatory agencies, Carpenter suggests that by according importance to the interests of such audiences the FDA has manage to retain such power.
The push for relaxing regulation in the US FDA can be traced to the years following tightening of FDA processes in the wake of the thalidomide crisis. In 1962, The Kefauver Amendment to the Federal Food, Drug and Cosmetic Act (in response to the Thalidomide crisis) was enacted to tighten (i) pre-market review of safety and efficacy of every new drug candidate, (ii) through a three-phase clinical trial process, (iii) using statistical methods popularly known as Randomised Control Trials (RCTs). By the end of the 60s and 70s, these regulations were held primarily responsible for slowing the FDA's approval processes and came under considerable fire for slowing the US drug discovery pipeline compared to counterparts in other countries. In response, the Reagan administration sought to speed up US drug discovery with a ‘radical deregulatory agenda’ and in 1992 signed the Prescription Drug User Fee Act into law. The Prescription Drug User Fee Act (since amended numerous times) was intended to allow the FDA to collect feeds on human drug and biological products in order to expedite the drug approval process.
At the same time, 'deregulation' has not been without its critics. For instance, some have blamed the the Vioxx crisis (2004) as a negative fallout of FDA's deregulatory turn. A study of the Vioxx episode by Woodcock (Clinton and Wechsler 2006) highlights the inadequacy science in general and the existing drug discovery methods in particular, to provide a credible solution to similar crises. For Woodcock, the key need is to shift away from existing statistics-dependent testing methods on broad pools of patients towards targeted clinical development on individual patients likeliest to benefit from a drug (Clinton and Wechsler, 2006). Increasingly, it is the latter 'individual patient focussed' solution -popularly called Pharmacogenomics that presents a credible drug discovery alternative as the best way if you will to ‘establish unmet medical needs, and identify patients who are predisposed to adverse events’’ (Woodcock 2011, p15).
In summary, while pharmacogenomics is often viewed as a result of the neoliberal turn for deregulation, at the same time it holds considerable promise as a better vehicle (than existing drug discovery processes) for delivering vital public goods like cheaper and faster drug development etc.