I have a clear written mandate that guides this decision. The other alternatives do not have the same clear, written mandate as the one that I made. While a utilitarian approach may have yielded a different decision, in my position as a safeguard of public safety I am not obligated to undertake a utilitarian position unless I can do so without compromising my primary mandate. This is something I was able to do with generic drugs that I cannot do with biosimilars, even though it would be expedient for me to ignore the differences between the two products.
There are certainly those who would object with this decision. A utilitarian in particular would have a strong argument that total health outcomes depend not only on drug safety but on availability as well. I would argue, however, that this objection is invalid for a couple of reasons. The most important of these reasons is that there is a difference between the moral obligation that I have and the ideal outcome. The utilitarian outcome is ideal, I would agree, but when I have a clear mandate, that takes precedence over finding the ideal solution. It should be noted that the utilitarian calculus, when undertaken by different stakeholders, will result in a different policy prescription. While striving for the ideal is admirable, there is no consensus ideal so subsuming my written mandate for pursuit of an elusive notion of ideal is not the best course of action. The second reason is more straightforward -- as an agent of the federal government I ultimately take my marching orders from them. If the government wishes to change my mandate, either for its own benefit or for the benefit of any other stakeholder, it has the power to do so. At such a point, I would need to reconsider my decision. For now, I can only work with the confines of my mandate -- price and availability of biologics is not a part of my mandate, and until it becomes one I am not obligated to consider those issues as primary.
I believe that my view may be frustrating to those with high moral virtue. It may seem that by ignoring utilitarian concerns I am passing the ethical decision making to others. However, within the confines of the political system in which we operate, I act as an agent of the American people with a specific mandate. The designers of the system are charged with the responsibility of portioning out mandates...
Acting outside of my mandate as agent of the people would be a violation of my duties as agent. While this may result in less than ideal solutions, morally I find that I must fulfill my duties, rather than impose my own moral and ethical views on the majority. I have not been charged with that duty, and I need to respect that I have not been given that duty.
However, it is also worth considering that high moral virtue can be interpreted a number of ways. For some, staying within the boundaries of one's agency role is high moral virtue. The idea that high moral virtue comes from ideal utilitarian outcomes is in contrast with the deontological, rules-based nature of what we do. The government is not a monolithic entity whereby the FDA or CBER is conscripted to perform all of the tasks that a government ideally should. Indeed, such bodies are ours are only conscripted to perform certain specific tasks that are defined within the framework of law. So one's definition of high moral virtue is dependant on whether one takes a deontological or utilitarian view of the role of government. Within government, however, is it clear that the deontological view holds as the most important, so I feel that there is no virtue in taking a utilitarian approach, even if it brings the outcomes closer to the ideal.
I would be comfortable presenting this plan to the public. Although the ideal outcome would be to find a way to treat biosimilars are the same as generic drugs, they are qualitatively different. Wanting something to be a certain way does not mean that it is. The desires of secondary stakeholders, while worth considering, are not an appropriate means by which to solve ethical dilemmas. If there was an absence of clear directive with respect to my duties, I would perhaps be more open to the utilitarian view. It is certainly the safer approach, to give something to everybody when the policy is decided upon. However, because I have a clear mandate in my role as a public servant, I need to remember that mandate when setting policy.
The public must understand that each public agency has its role in our system of governance. Each piece of legislation has a role within our system of governance. To step outside that role, even when utilitarian and pragmatic, is a threat to the system. Morally and ethically, I must act within my defined role, defined mission and defined duties, in order to deliver the best outcomes for the American people. I believe that with this analysis I have done that, and that the result will be that the FDA will uphold its core mission of ensuring the safety and efficacy of biosimilars.
Van Arnum, P. (2010). Healthcare reform draws mixed reviews from pharmaceutical and biotechnology industries. PharmTech.com. Retrieved December 8, 2010 from http://pharmtech.findpharma.com/pharmtech/Regulation/Healthcare-Reform-Draws-Mixed-Reviews-from-Pharmac/ArticleStandard/Article/detail/662434?contextCategoryId=48563
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