Ethics and the FDA

Kaiser is reporting that certain interest groups are calling on the FDA to take different variables into consideration besides safety and efficacy when approving drugs:

The Baltimore Sun on Monday examined how some critics are saying that FDA or another government entity should "look beyond the safety of the foods and drugs it regulates and consider decidedly unscientific factors, including the ethics and health care costs of approving certain products." Such a move would "represent a radical departure for the FDA, which prides itself on making data-driven decisions free from political and industry influence," according to the Sun. The Sun reports that issues raising ethical and social behavioral issues include considerations of the emergency contraceptive Plan B for over-the-counter sales and the possibility of products that are derived from cloned animals being sold.

Somehow I doubt that those behind these propositions are actually concerned about cost. No, I'm quite sure that they're only concerned about "ethical" questions, like whether Plan B should be available over the counter (or, for that matter, available period).

But why should cost be considered in terms of actually approving treatment for production? Cancer and AIDS therapies are prohibitively expensive -- often tens of thousands of dollars a year -- but that doesn't mean they shouldn't be produced at all. It's up to insurance providers (be they private or publicly paid for) to decide what will be covered. Those decisions should depend on the efficacy of therapies. Cancer treatments save lives, and for most of us that multi-thousand dollar cost is worth life. Inevitably we pay for insurance and pay taxes because we know if we were in a situation requiring expensive care that we'd need (and want) help.

Any effort to alter the FDA's role as a certifier of safety, efficacy, and objectivity is a slippery slope. Approval centered on ideology or cost concerns should be left up to payers and representatives. The agency will become useless if it opens itself to these concerns -- it has enough trouble making decisions as is.

Comments

[Martin]

Kate, another interpretation is that it is an attempt to pass the buck so that Medicare need not explicitly say that a treatment is too expensive to be reimbursed. I can imagine the electoral difficulties that any politician would face if he or she voted in favor of allowing CMS to consider cost in deciding whether to reimburse a particular device, drug, or procedure at all.