Mixed Reactions to Senate Hearing on Neglected Diseases

Capitol Hill put a spotlight on the process for developing therapies and other products for neglected diseases last week during a congressional hearing featuring CGD visiting fellow Tom Bollyky, but with mixed results.I was encouraged to hear representatives from the U.S. Federal Drug Administration (FDA), National Institutes for Health (NIH) and U.S. Agency for International Development (USAID) commit to do more on neglected diseases. And it was nice to hear Jesse Goodman from FDA emphasize his agreement with many of Bollyky’s key recommendations. But at the end of the hearing, there was still little clarity about what actions and resources the FDA and its partner agencies will commit to in order to improve the development pathway for neglected disease products beyond currently existing programs and initiatives. Goodman mentioned, for example, his desire for product developers such as public-private development partnerships (PDPs) to come to FDA earlier in the development process, but offered little detail on the outreach and programmatic support that FDA will provide to make that happen. Nor did FDA commit to issue guidance and initiate more collaborative programs with WHO on neglected disease drug and diagnostic development, something it has already done for vaccines. NIH and USAID reported some positive steps and ambitious goals in their respective efforts on neglected disease, but there was little detail on how they can work with FDA to facilitate the late-stage clinical development and approvals of much-needed therapies – usually the most difficult and expensive components of the R&D process.Pursuant to a requirement in the FY 2010 Agriculture Appropriations Bill included due to the efforts of Senator Brownback, FDA recently launched a review group on neglected diseases. The new Global Health Initiative (GHI) likewise has broad commitments and goals on neglected diseases. As these efforts move forward, we hope to see some bolder, more concrete actions that could shake up the existing paradigm and significantly streamline and improve the development process for products for neglected diseases.What steps do you think the FDA, USAID and their partner agencies should take?