Moral analysis within public organizations

Moral Analysis

The Food and Drug Administration (FDA) is responsible for regulating medical products and treatments, including the emerging area of biologics. This product category falls under the CBER (Center for Biologics Evaluation and Research) wing of the FDA. There are a number of different types of biologics, each one defined roughly as medical products derived by biological means, rather than chemical (drugs) or mechanical (medical products). Examples of biologics include vaccines, blood and blood components, allergenics, gene therapy, tissues and recombinant therapeutic proteins. The most important ethical dilemma with respect to biologics is with respect to the treatment of biosimilars.

Biosimilars are the biologic equivalent of generic drugs. To offset the high development cost of pharmaceuticals -- these costs typically run into the hundreds of millions -- manufacturers are granted by the FDA a period of exclusivity with respect to marketing the drugs. This allows drug companies to earn enough profit from successful drugs to cover the development cost, as well as costs associated with drugs that do not reach the market. After the period of exclusivity ends, other companies are allowed to manufacture the drug. These are known as generic drugs, and they have identical chemical composition to the original. Generic drugs benefit consumers because competition in the industry drives down the price. The regulatory pathway for generics is short and cheap, relative to the pathway for the original drug, because there is no need to duplicate clinical trials for an identical product.

The biosimilar is the same principle as a generic drug, but for biologics. The difference is that for a number of reasons it is impossible to make the biological product exactly identical to the original. Thus, there is no regulatory pathway at present for biosimilars -- they must all undergo the same testing as any other biologic. This means that there are no cost advantages to entering this market. Prices cannot be low because development costs are always high. This poses a problem for the FDA, however, because the number one customer for biologic treatments is the federal government, through Medicare and Medicaid. There is a conflict of interest between the FDA's need to properly and thoroughly regulate biosimilars and the federal government's need to reduce health care costs, something that is considered a high priority for the government given the long-run deficit issues it has (Van Arnum, 2010). The FDA is currently seeking guidance as to the best approach for a biosimilars pathway in order to resolve this dilemma.

Possible Alternatives (3,4)

There are roughly three types of alternatives to this situation. The first two involve giving moral priority to either one or the two side of the argument. A safety-first approach takes the view that the FDA's role is to uphold consumer safety as the highest standard of its activities. The second is to uphold a more utilitarian approach. In the middle is the third alternative, a compromise pathway akin to what is already in place in the European Union. In order to analyze these different alternatives, it is important to consider the stakeholders.

The main stakeholders to consider are the consumers of the drugs, the federal government/taxpayer and the companies that develop biologics. The latter group can roughly be broken into two categories -- those that develop and market originator biologics and those that develop and market biosimilars. From the consumer perspective, the balance between quality and cost is an important one. Not all consumers will agree on the appropriate balance between these two. For its part, the FDA is charged with safeguarding safety and efficacy in the products under CBER. This mandate can be seen as a categorical imperative for the FDA, as it is not only a written mandate, but is symbolic of the ethical guidepost by which the FDA should operate. The history of the FDA shows that consumer protection is the reason the agency was brought into existence. That some consumers are willing to make a price/quality tradeoff is not relevant from the point-of-view of the agency or its mandate.

The federal government/American taxpayer is the largest consumer group, however. This status alone makes it a special stakeholder, but the fact that the FDA is a federal agency and therefore subject to financing and laws from the government only increases the importance level of this stakeholder. The needs of this stakeholder are twofold. Under the Medicare and Medicaid programs, this stakeholder seeks to facilitate positive health outcomes for a large set of Americans. The federal government is also facing a long-run deficit crisis, an aging American populace, and health care costs that now account for 19%, a figure that is only expected to increase.

The final stakeholder group consists of the opposing forces within the industry. Each side has a vested financial interest in this dilemma, but from a commercial rather than ethical perspective. The amoral nature of these stakeholders' investments means that their concerns are subjugated to those of the consumers and the federal government.

The first alternative fulfills the FDA's obligation to the consumer, especially as the mandate of the FDA discounts the question of access to drug (price). However, the second stakeholder group explicitly demands that price be a consideration in the policy that is developed. As such, the second alternative involves making a sacrifice (potentially) to the safety objective in order to meet the cost objective. The third alternative attempts to meet these two objectives in the middle, but current European legislation is still oriented much more to safety, with a slightly shorter period of market exclusivity that in theory will encourage biosimilars by increasing their profit potential.

Moral and Ethical Implications (5,6,7)

Depending on the alternative, the action is either morally required or is an ideal to which the FDA aspires. The moral requirement is to ensure consumer safety. This is a moral requirement because it is the reason the FDA was set up in the first place, and the primary role of the agency. The agency acts as an agent, on behalf of the American people, to protect them from products that either do not work or that are unsafe. In this role as agent, the FDA is guided by specific mandates that demand it place emphasis on consumer safety. These mandates form the basis of the categorical imperative by which the FDA should operate.

In choosing either the second or third alternative, the FDA would be appealing to an ideal, which would be to deliver not only safe medical solutions, but affordable ones as well. Perfect access to health care is not a basic human right granted upon birth, but is rather an ideal to which we aspire. It could be argued that in the current American medical system and political climate, delivering perfect health care access is not even a core national value. Nor is it a core moral obligation of the federal government to balance its budget, to the extent that it continues to have access to cheap capital (which it most certainly does). While the agency often takes a utilitarian approach that balances the interests of all three major stakeholders, there is no explicit moral obligation to take a utilitarian approach to the issue.

In the most promising alternative -- a full consumer protection approach -- there is no specific ethical obligation that applies. The obligation derives from the mandate of the agency with respect to its role as agent of the American people. The argument could be made, however, that the agency is killing people when it places safety ahead of price, meaning that if people cannot afford the biologics then the agency is in a way killing them. The agency has voluntarily involved itself in the price/profit issue in a number of ways, but has largely done so as a result of legislation mandating such behavior. Unsafe biologics could also kill people, which balances this concern. Ultimately, in absence of clear direction from the legislative branch that ensuring low prices is a mandate of equal importance, the FDA must assume that safety is its only concern, and that avoiding death as the result of unsafe products is the only true ethical obligation it has.

Understanding that, there is no remaining ethical issue. The duty that the agency has is clear, and while it has in past attempted to meet the needs of other stakeholders, it is under no specific legal or moral obligation to do so. The needs of those stakeholders are ideals, not moral mandates.

Analysis (8,9,10,11,12)

My motives in this decision are amoral. It is the view that self-interest does not play a role in this decision, as if I am the head of the FDA or of CBER, I have no personal stake in the outcome. I am simply working within the confines of my mandate on this decision. The decision clearly could have been approached from a utilitarian point-of-view, but in this case a deontological analysis was used. The deontological approach in this case is based on the clear delineation of duties with which I am faced in this position. 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 to different parties. 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.