By Seán Finan

On 16^th September, 2016, the White House released two documents jointly authored by the FDA, the EPA and the USDA. Together, the “Update to the Coordinated Framework for the Regulation of Biotechnology” (the “Update”) and the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the “Strategy”) will form the basis for the federal government’s regulatory policy for biotech for the foreseeable future. So, where did these documents come from? What do they contain?

Background

Last year, the federal government asked the FDA, the EPA and the USDA to

1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
2. Develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
3. Commission an expert analysis of the future landscape of biotechnology products

(Source)

14 months, three public meetings and 900 responses to a Request for Information later, the two documents were released. The Update sets out to respond to the first of the above prompts and the Strategy aims to respond to the second. An answer to the third is still in the pipeline.

Aims

The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):

The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers

Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim

• to help the public understand how the safety of biotechnology products is evaluated and
• to help businesses navigate the current regulatory structure.

The Update

The recent Update, as the name might suggest, sets out to update the Coordinated Framework for the Regulation of Biotechnology (the “Coordinated Framework”), first issued in 1986 and previously updated in 1992. The 2016 Update contains four main parts. The first highlights the types of biotechnological products that fall under the existing regulatory framework. The second links the regulatory agencies with their corresponding areas of responsibility. The third summarises a series of Memoranda of Understanding that “enhance coordination and enable sharing of information among agencies”. The fourth establishes a five year period for the review of the Coordinated Framework, including an annual report on the implementation of the Strategy.

The Update also highlighted a number of challenges faced by the current regime. For example, uncertainties over the jurisdiction of particular agencies have raised costs for both the agencies and private parties. Many products cross agency boundaries, making it more difficult to determine where regulatory responsibility lies.

The Strategy

The Strategy is built around three principles; increasing transparency, increasing predictability and supporting science.

• Transparency: goals include working “with stakeholders to identify impediments to innovation”, developing tools to help small business navigate the regulatory framework and to present the regulatory framework to the public and to clearly communicate “which types of products are regulated, which types of products are not regulated, and why” (p8)
• Predictability: goals include formalising a periodic assessment of emerging technologies to ensure the system is prepared for future products and to “ensure product evaluations are risk-based and grounded in the best science available, including regularly adjusting regulatory activities based on experience with specific products and the environments into which those products have been introduced” (p9)
• Supporting Science: goals include increase cooperation, coordination and support of federal research agencies so that regulation is supporting science to the greatest extent possible.

Assessment

So, what are we to make of this news? Telling is the fact that it barely made the news. A Google news search for “biotechnology” for the period 16-20 September 2016 will bring more news about the end of the war between men and rats than the White House announcement. The press release itself describes the documents as a “major step forward” but acknowledge that “there is more to be done”. Taken by themselves, the Update is intended only to provide clarity and the Strategy only a rough path. However, the release shows a comforting commitment by the government to the future of biotechnology and its regulation. The annual reports on the implementation of the Strategy should provide five years of interesting reading.

Another point of interest is the commitment to mechanisms of deliberative democracy and public input apparent in the documents. The Strategy in particular emphasises the importance of making information accessible. It advocates involving “advisory committees of experts in key disciplines”, taking “public input on regulations and guidance documents” (p12) and holding workshops and webinars. And, as noted above, the documents themselves were generated with the help of significant public input. The use of public input to help regulate emerging biotechnologies is certainly superficially commendable, from the point of view of democratic governance. However, I can’t help but wonder just how effective communication methods will have to be to gather considered input in a field as prone to provoking knee-jerk reactions as biotechnology.

There was also note of caution against rapid regulatory changes, particularly in the face of rapid technological change. The Update quoted a working group commissioned by the Regan Administration to examine the regulation of the then new technology of genetic manipulation: “The existing health and safety laws had the advantage that they could provide more immediate regulatory protection and certainty for the industry than possible with the implementation of new legislation”. (p3)

Two final points of interest: the documents clearly show that the federal government wants to focus on promoting innovation while minimising the risks associated with biotechnology and creating a fertile business environment. Equally telling, however, is the confession by omission. The documents contain little reference to assessing the benefits or the positives of any biotechnologies: that progress is positive seems to be simply assumed. Neither document contains the word “ethic” or the word “moral”.

Perhaps it is over-simplistic to assess the underlying policy in this manner. However, it seems that the government intends to take a fairly laissez-faire approach to biotechnologies: try to minimise direct harm and let the free market take care of the rest. Perhaps it isn’t the place of the government to direct research. However, the free market doesn’t necessarily tend towards the common good. Research is ultimately a profit-oriented business. To take the example of medicine, 1393 new drugs entered the market between 1975 and 1999 (see Trouiller et al, ‘Drug Development for Neglected Diseases: a deficient market and a public health policy failure’ (2002) 359 The Lancet 2188). The majority of these drugs were aimed at diseases most prevalent in developed countries. Only 16 were aimed at treating diseases that ravage tropical third world countries. Only 21 made the WHO Essential Drugs List and 68.7% presented little or no therapeutic gain. In the absence of at least one publicly-minded hand on the steering wheel, I find it difficult to imagine these statistics will change. Good news for male baldness, perhaps, but bad news for malaria.

However, maybe this is as it should be. Perhaps we should trust the public spirit of private individuals and assume that the general rising tide of technology will continue to improve lives even with a strong focus on profits. Maybe (and I am indebted to Kelly Dhru for bringing this article to my attention), bioethicists should heed the advice of Steven Pinker and simply “Get out of the way”.