The OIRA Module: Published Research

From: Bloomberg

By Cass R. Sunstein

The Food and Drug Administration has outlawed the only over-the-counter asthma medicine in the U.S. It has also banned a number of other asthma medicines that patients like and that doctors have prescribed for them.

In imposing these prohibitions, the FDA hasn’t denied that the banned asthma medicines are safe and effective for their intended use. (Disclosure: While serving as administrator of the White House Office of Information and Regulatory Affairs during President Barack Obama’s first term, I participated in discussions of some issues examined here.)

The FDA is supposed to help patients, not hurt them. Why does it ban asthma medicines?

The answer lies in the Montreal Protocol, a treaty the U.S. ratified in 1988. Strongly supported by President Ronald Reagan, the Montreal Protocol was designed to phase out chlorofluorocarbons and other substances that deplete the ozone layer (and thus increase the risk of skin cancer and cataracts). The U.S. ratified the treaty in part because its benefits were found to outweigh its economic costs (and by a large margin).

At the same time, the Montreal Protocol has produced some less-than-ideal consequences. Asthma medicines have long been delivered through inhalers that use CFCs. Under the language of the treaty, there is a strong argument that such inhalers must be banned, even though they contribute very little to depletion of the ozone layer, and even though such bans can make asthma medicines more expensive and less easily available.

Balancing Risks

Asthma inhaler bans turn out to be a troublesome case study in “risk-risk tradeoffs,” which arise when a well-motivated effort at reducing one risk ends up increasing or creating another risk.

The Montreal Protocol allows exemptions for “essential uses.” In 2002 (during the George W. Bush administration, not usually known for regulatory overkill), the FDA issued a complex rule intended to establish when an asthma medicine would count as “essential.”

According to the FDA, a central question is whether there are “technical barriers” to formulating the product without ozone-depleting substances. If no such barriers exist, the FDA indicated that it would not deem the product to be“essential.” This is a difficult test to meet, because“technical barriers” can often be surmounted in theory (even if they aren’t surmounted in reality).

After adopting its 2002 rule, the FDA has taken numerous steps to ban asthma medicines. Consider a few examples.

For several decades, Primatene Mist was the only over-the-counter asthma inhaler sold in the U.S. Several million people used it every year. For some of them, Primatene Mist was a“fill-in” drug, purchased when their prescription for asthma medicine ran out. For those without serious or chronic asthma, Primatene Mist seemed well-suited to occasional use. Asthma sufferers lacking health insurance or a regular doctor liked the over-the-counter option because Primatene Mist was inexpensive and easy to buy. This group included a number of poor people.

It is true that many doctors, including asthma specialists, were unenthusiastic about Primatene Mist, which could have harmful side effects, including headaches and dizziness. In their view, asthma sufferers should be under regular medical care, and prescription medicines would do significantly better in addressing their problem.

Further Bans

But when it banned Primatene Mist (in 2008, in the closing months of the Bush administration), the FDA didn’t act for that reason. Nor did it examine whether, for reasons other than the Montreal Protocol, the nation’s only over-the-counter asthma medicine should be removed from the market. Indeed, the agency explicitly relied on the treaty and acknowledged that the resulting ban could cost “hundreds of millions of dollars annually, and increase hospitalizations and emergency department visits for asthma significantly.”

The FDA has also prohibited numerous prescription medicines. Again during the Bush administration, it bannedwidely prescribed albuterol inhalers that used CFCs. The good news is that CFC-free substitutes are available. The bad news is that the substitutes have been significantly more expensive, and many asthmatics don’t think they work as well.

By the end of this year, moreover, asthma sufferers will beunable to purchase the Maxair Autohaler, which has been used by hundreds of thousands of Americans who say they benefit from its unique delivery system. Giving notice of the ban in 2010, the FDA deserves credit for providing consumers with ample time to seek alternatives. But some asthma sufferers won’t be happy to learn that their own government has made their preferred asthma inhaler unavailable.

Asthma is a serious problem in the U.S., particularly among the poor. We need to be devoting a lot of attention to how to make effective medicines both cheaper and more available. Neither the Montreal Protocol nor the FDA can be blamed for the current situation. But it isn’t terribly helpful if the federal government is forbidding medicines that are significantly cheaper and, for some patients, more effective than those that are allowed on the market.

(Cass R. Sunstein, the Robert Walmsley University professor at Harvard Law School, is a Bloomberg View columnist. He is the former administrator of the White House Office of Information and Regulatory Affairs, the co-author of “Nudge” and author of“Simpler: The Future of Government.”)