Newly appointed US Food and Drug Administration Commissioner Margaret Hamburg and FDA Principal Deputy Commissioner Joshua Sharfstein provided a broad vision for FDA in a recent New England Journal of Medicine article by asserting that the primary role of FDA should be as a public health agency and stressed the value of building collaborative models with other federal agencies, industry, and other national regulatory bodies in serving that function.
In the article, Hamburg and Sharfstein emphasized that FDA’s job is to support access to a safe and nutritious food supply and innovative, safe, and effective medical products as a means to promote health, prevent illness, and prolong life. “The ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved,” say the officials in the article.
The officials concede that FDA has “struggled” to handle incidents involving the safety of regulated products, and those incidents have legitimately opened debate from the public, the media, and Congress about the agency’s ability to serve the public interest and that a fresh perspective is needed for the agency. “Establishing FDA as public health agency requires a culture that encourages scientific exchange and respects alternative viewpoints along the path of decision making. It also requires that the agency define and protect integrity in its basic processes,” say the FDA officials in the article.
To achieve that goal, they stressed the need for transparency in communication and concede that the greatest challenge facing the agency is risk communication. “FDA’s job is to minimize risks through education, regulation, and enforcement. To be credible in all these tasks, the agency must communicate frequently and clearly about risks and benefits and about what organizations and individuals can do to minimize risk,” say the officials in the article.
They also emphasize the need for FDA to go beyond the traditional tools of regulation, approval or disapproval or applications, and enforcement, and to look for opportunities to advance science in the fields that it regulates and to work with other federal agencies and outside partners to address problems that the agency cannot solve alone. They acknowledge that “globalization intensifies all the challenges the agency faces” and assert that the responsibility for the safety of a pharmaceutical product be shared not only by the pharmaceutical manufacturer but also by other players in the pharmaceutical supply chain, including the country of origin, the importer, and the importing country.
How this broader vision for FDA to more fully function as a public health agency rather than just a traditional regulator will materialize into specific policy decisions and actions is the critical question for the pharmaceutical industry. Let us hope that this new focus will be as productive as envisaged by the new leadership at FDA.