About this blog

CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.


Regulating Medical Products in the Interest of the Public

October 25, 2017

In June 2017, Yale CRIT hosted an international conference titled “Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation.” The following blogpost is the tenth installment of a blog series with commentaries from the conference participants. The views and opinions expressed in this blogpost are those of the author and do not necessarily reflect the position of Yale CRIT. For more blogposts related to this series, see here or click the tag “YaleCRIT17” below.

There seems to be a deep confidence crisis in the US Food and Drug Administration (FDA) as an institution. We hear claims of it being permeable to industry lobbying, of taking the side of pharmaceutical companies instead of that of Americans, and of political considerations having more weight in its decision-making process than the health of US citizens.

Although the European Medicines Agency (EMA), the FDA’s European counterpart, is at times “credited” with the same kind of failures (it is a great failure in a democracy when public institutions can no longer be trusted), there is a fundamental difference between the US and almost every EU member state: healthcare is primarily a public matter in any EU member state. Health insurance and healthcare providers are mostly financed with public money while in the US both health insurance and health providers are mainly private, profit-driven actors.

When drug regulation is stripped of any public health dimension (when health is not a public matter), it becomes a purely technical legal process, a race in which the regulated industry will use all available means to circumvent the existing regulations and the regulator will be consistently trying to cope by increasing resources, pushing for more regulations, etc.

In this absurd race, the pharma industry seems to be always one step ahead. With their inexhaustible resources, winning the “regulation game” becomes easier. Hence, putting the health of Americans in the hands of multiple private actors makes the possibility of exerting a badly needed counter-power by the people and their elected deputies virtually impossible. Having for instance a parallel, academia-based, evaluation system that would proof-check FDA’s decisions seems unrealistic and has no legal ground.

There is also a deep crisis with the pharma industry. As financial actors, they obey the same rules as any other stock-market listed industry and are therefore primarily interested in maximizing their profits while minimizing their risks and their investments on projects with long return on investment lead times. Their interest in the subject matter, i.e. the medicine they develop and market, is denuded of any public health considerations. It seems natural then that in terms of regulation, the pharma industry will use all its political and economic weight to make sure that the regulatory process will not only fail to control these profit-driven strategies -- which result quite often in products with dubious benefits -- but will also facilitate them as much as possible.

What we need to address is not only the capacity of the regulators to put down the “bad guys” but also the activity they regulate, i.e. medical R&D and marketing which have been constantly losing any ethical grounds, creating public mistrust and paranoia not only vis-à-vis the pharma industry but also the government and its agencies.

We need to re-establish public health in the heart of the R&D process. We need to make sure that economically viable and efficient R&D alternatives are being promoted, and that existing actors involved in truly innovative basic and early medical R&D have alternative partners and models to push their inventions down the pipeline. Regulatory agencies need to make sure that these actors are given priority over profit-oriented companies and that public health benefit is defined as a core, in principle, requirement to any new drug application.

Alain Alsalhani works for Médecins Sans Frontières (MSF) and MSF’s Access Campaign. His primary areas of work relate to the regulatory challenges to access, with a specific focus on vaccines. All views and opinions expressed in this commentary are the author’s own in his individual capacity. They do not reflect the views of MSF or Access Campaign and should not be attributed to MSF or Access Campaign.