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Public Health Regulation as a Public Process

Media coverage of new public health regulations often seems to follow a template:

Joshua M. Sharfstein, MD

The [regulatory agency]’s plan to implement [public health regulation] is causing controversy among [businesses affected] and [individuals who object]. While public health officials say the plan is needed in order to address the [public health problem] that affects [statistics], opponents believe the plan to be an example of government interfering too much in [topic area].

These news stories carry the implication that all sides of the issue are frozen into position and that policy making is little more than a power struggle.

But there’s another way to think about how policy is developed to improve health: as a dynamic process open to a range of policy alternatives. Besides adopting binding regulations, agencies can take a range of other steps, such as educating about a health threat, asking for public reporting of data, and encouraging voluntary efforts by key parties.

The process of deciding which tools to use can have a big effect on the eventual outcome. After defining a public health issue with data, agencies can seek broad input on solutions, including feedback on specific ideas. I have seen public engagement around problems generate interest and momentum, while altering the initial positions of regulators, industry, and others.

Where there is no consensus, an agency may decide that steps short of regulation can accomplish the intended goal. Or the agency may opt to press forward. In my experience, contested regulatory action has a greater chance of success when the process leading up to the decision effectively engaged the public.

Here are 3 examples:

  • When I served as health commissioner in Baltimore, the US Centers for Disease Control and Prevention (CDC) reported the case in 2006 of the death of young child who swallowed a piece of decorative metal that came with a sneaker. Our health department collected data and found high lead levels in children’s jewelry for sale in the city. We released these findings, leading to wide media coverage of the potential risk. When we pursued whether retailers would be interested in a voluntary agreement not to sell such products, this turned out not to be possible. We then proposed and later implemented a regulation banning the sale of children’s jewelry with high lead levels. Our staff later testified before Congress on our efforts, contributing to federal legislation that established a strict standard across the country.

  • At the US Food and Drug Administration (FDA), where I served as principal deputy commissioner, I was involved in efforts that led to a ban on caffeinated alcoholic beverages. This effort began in November 2009 with a public expression of concern and call for information from companies, generating considerable media attention. By the time the FDA took regulatory action about a year later, there was broad understanding of the risks of these products among key officials, the media, and many in the public. The FDA was joined by 2 state attorney generals, an expert from the CDC, an official from the Federal Trade Commission, and a senior official from the Alcohol and Tobacco Tax and Trade Bureau in making the announcement. Remaining caffeinated alcohol beverages were later converted to ethanol fuel.

  • More recently, Maryland’s Department of Health and Mental Hygiene has explored the issue of crib bumper pads, which have been associated with infant deaths. We held 2 public advisory committee meetings in May and July of 2011 and several public comment periods on how to address the issue. After internal and external discussion, we recognized that there existed not only scientific justification, but also support from the local editorial boards, injury experts, physician organizations, and many others to take action. We made some adjustments to the proposal based on public input and then moved forward. The ban on sale of baby bumper pads, the first at a state level in the country, takes effect next month.

In each of these cases, there was extensive public dialogue on the problem before there was a decision to pursue regulatory action. By the time we moved forward, there was considerable understanding of what our agency was doing and why.

So when regulations are needed, this is the kind of coverage I hope to see:

The [regulatory agency] is implementing [public health regulation] in order to address [problem]. The action, which is supported by [key group No. 1], [key group No. 2], and [key group No. 3], comes [time period] after it was first proposed.

In taking this step, the [regulatory agency] heard from [opponents] concerned about [objections]. In hearing these concerns, the agency modified its original proposal by [modifications] and determined that [other alternatives] were not going to be effective. A smooth transition is expected.

About the author: Joshua M. Sharfstein, MD, is Secretary of the Maryland Department of Health and Mental Hygiene. He has previously served as the Principal Deputy Commissioner of the US Food and Drug Administration and as Commissioner of Health for Baltimore. A pediatrician, he lives with his family in Baltimore.
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