New GHTC resources highlight FDA’s critical role in global health

The GHTC has long stressed that the US Food and Drug Administration (FDA) plays a critical part in efforts to improve global public health. While the FDA is best known for its work to protect the health of US consumers, the agency has a strong history of sharing its expertise to benefit people worldwide and is playing an increasingly vital role in global health issues. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide.

Our new fact sheet and policy brief focus on five key areas at the FDA. First, the FDA leads numerous international programs from its headquarters in the United States and operates offices and posts in ten countries across the globe. As the agency expands and deepens its contributions to global health, it is essential to ensure FDA’s activities contribute to an agency-wide strategy. Therefore, the FDA should create an office of neglected diseases so that it can better drive coordination among its centers and offices to maximize its global—and domestic—health impacts. This new program should be housed within the FDA’s Office of the Commissioner. By formalizing the agency’s global health activities, better oversight can help ensure that related programs and initiatives contribute to a unified goal.

The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Credit: PATH

The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Credit: PATH

Second, the FDA should continue to build partnerships with global regulatory stakeholders, such as the World Health Organization and national regulatory authorities. Regulatory review of products designed for use in the developing world can be particularly challenging, especially when the national regulatory authorities do not have the capacity or resources to manage the reviews. To address this issue, the FDA offers trainings and contributes to global efforts to improve regulatory harmonization. The agency also supports a variety of global regulatory initiatives. But this is just the beginning. To realize the positive impacts of these investments, FDA should continue to contribute to and expand these efforts.

Third, while FDA has taken impressive steps to increase its engagement globally, without formalized reporting and oversight mechanisms the outcomes of this work can wane in the face of other priorities and funding constraints. To increase transparency and accountability for its global health commitments, the FDA should take steps to establish formalized processes to report to Congress on its neglected disease activities.

Fourth, while its first priority is the health of Americans, it is essential that the FDA arms itself with global health experts who can help carry out a comprehensive plan. To strengthen the work already being conducted in the agency’s international offices and posts, FDA should dedicate additional staff members and resources to global health engagement.

Finally, FDA—like so many agencies across the US government—is facing severe financial constrains due to sequestration and broader budget cuts. We’re facing the possibility of a government shutdown at the end of this month, as congressional policymakers still have not reached an agreement on the federal budget. Without question, this financial uncertainty hinders FDA’s ability to strengthen its role in global health and safeguard the health of American citizens. It’s critical that congressional policymakers pass a smart budget agreement that avoids another round of sequestration cuts while protecting key programs at FDA and other federal agencies that work in global health. As House and Senate leaders continue their budget negotiations, they have the opportunity to demonstrate their commitment to lifesaving and efficient programs at leading agencies like the FDA.

Kim Lufkin is the GHTC’s communications officer.

This entry was posted in Congress, FDA. Bookmark the permalink.

One Response to New GHTC resources highlight FDA’s critical role in global health

  1. You touch on the issue in your final point, but already in your third point the political climate of DC can be seen to have a truly global reach. While many domestically look at FDA as a target for spending cuts and even vilify the agency as anything from a puppet of big pharma to a punctilious impediment to progress, fewer people take time to understand the vital role of FDA within and without our borders. I fear that asking FDA to take a more transparent and outspoken role in international health efforts while simultaneously (and justifiably, of course) reporting those efforts through formal channels to Congress would be used as ammunition against an agency already being painted as ineffective, unfocused, and beholden to international forces. In this Congress, many consider (at least in public rhetoric) the United Nations to be “the enemy.” Asking FDA to boldly expand and report on its work with WHO for example, in this environment, might have the exact opposite effects of those we would like.

    I have personally experienced difficulties you allude to in the lack of responsive regulatory guidance in a rapidly (which is an understatement, I know) expanding global pharmaceutical development effort. Some day, I hope to be able to help shape guidance for Health Ministries to adopt. In the current regime there are examples of cooperation from groups like GAVI, whose willingness to work early and directly with pharmas is one of the most effective ways to ensure design of products that can be delivered effectively, globally. FDA should probably be ahead of this, providing guidance or seeking to improve guidance and set goals for everything from MDVs, VVMs/general cold-chain maintenance, formulation improvement without requiring new NDAs/BLAs, etc. There are myriad ways to improve the processes of development through delivery of pharmaceuticals. Everybody is pushing and being pushed to deliver better products, faster, and to more people. Often, we rely on accumulation of small, iterative improvements that don’t require regulatory input or approval. Too often, those small improvements come at tremendous financial cost, but we continue this way for fear of regulatory backlash. We’re reaching the right-wall, the limit of our capacity to improve on older/accepted methodology. We’re also spending too much money for diminishing return when we’d all rather be investing in new process.

    Your acknowledgment of and call to action for FDA offers an excellent map for where the agency should be trying to go, and be given the resources to go. It’s likely that FDA will find itself thrust into an increasing global leadership role as some other agencies are struggling to meet their mandates. I am, to be blunt, extremely worried that FDA is so misunderstood and misrepresented in politics and media that the agency will be lucky to survive the next several US election cycles without experiencing operational cuts. Like many organizations and programs affected by US political dysfunction, these cuts have and may continue to come when we most need to see the programs bolstered.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s