Posted On: October 11, 2011 by Patrick A. Malone

Making a Case for Considering Cost in FDA Decisions

Last week, Steve Grossman, an advocate for greater FDA funding, voiced an argument on his blog, FDA Matters, that not only should the government’s food and drug watchdog consider the safety and effectiveness of drugs, therapies and medical devices in its approval process, but also their cost.

In the past, Grossman has supported a split in medical treatment responsibility -- the feds conduct risk-benefit analysis, and insurers, physicians and pharmacists make decisions about cost-benefit. It’s hard enough to determine safety and efficacy without loading cost factor into the equation.

But, he writes, “Two events [recently] have left me wondering whether there are certain limited circumstances when FDA should be able to take product cost into consideration.”

The September publication in the British medical journal Lancet of a report called “Delivering Affordable Cancer Care in High-Income Countries” concluded that as cancer care becomes increasingly expensive, affordability, accessibility and value must factor into treatment.

Grossman knows that Medicare, Medicaid and private insurers will look to the report for insight into cost containment and support for tough decisions they make in the near future about who gets what treatment.

Thanks to problematic realities such as drug shortages in the U.S. – which disproportinately affect cancer drugs – Grossman says the FDA should have a voice in this conversation. “Patients suffer, research is delayed and more expensive drugs are often substituted (or patients do without),” he writes.

Apart from shortages and manufacturing problems, economics are helping to steer this issue into the danger zone. If it’s not sufficiently profitable for manufacturers to make older cancer drugs (because patent protection has expired), the FDA can’t address the shortage situation without considering cost. It might have to find ways to favor less effective or riskier products, Grossman suggests, only because they can be made available at a market-driven price.

The second event that prompted Grossman to reconsider the separation of medical treatment responsibility relates to the FDA’s unintentional role in exacerbating the crisis in affordable cancer care. Numerous new cancer products have joined the market in the last few years, more are coming, and they’re expensive -- about $100,000 per cycle. Some patients need multiple cycles or multiple expensive drugs.

So when asked what would the FDA do if a drug was only 90% as good as the safest and most effective therapy on the market (a metric that defines "standard of care") but would be available for only 10% of the cost, Grossman gave the stock answer: The FDA approves only therapies that are as good as or better than the existing standard of care. The cost aspect is not part of the decision.

Eureka! In light of the Lancet study, wouldn’t patients benefit if the feds had some room to consider standards of care, risk-benefit and comparative cost?

“It scares me to write this,” Grossman admitted. “the whole notion of FDA putting cost on the table seems like an abandonment of principles, as well as fraught with potential misuse.”

The FDA is not permitted to approve a drug, biologic or device that is not quite as effective or safe as predecessors solely because it will make care more affordable and accessible. “I am not yet an advocate for this,” Grossman states, “but I think it is one of the possibilities that we need to be discussing.”

It’s a pretty radical idea. But how often does significant, positive change occur on a grand scale without a radical element pushing the envelope?

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