It’s Been a Busy April at the FDA
If the rest of May goes as expected, then my next four or five columns are likely to be devoted to describing Appropriations Committee actions and analyzing appropriations numbers as they become available. Before we enter this high-energy, high-stakes period, this is an opportunity to consider the incredible breadth and depth of FDA activities. That is, after all, what the money is for.
FDA had a particularly busy April. To choose just a few items from around the agency:
- Implementation of the Food Safety Modernization Act continued, with key targets of regulations and programs that need to be in place by FY 15.
- Creation of a new accelerated review process for “breakthrough” medical devices
- Worked with Congress and the States on new science-based strategies for treating pain and simultaneously combating opioid abuse.
- Releasing a strategic plan for regulating health information technology and an implementation plan for improving the security of the drug supply.
- Sought public comment on ideas for improving the process of reviewing over-the-counter (OTC) drugs.
- Accelerated the availability of meningitis b vaccines by working with manufacturers and CDC to provide the vaccines during outbreaks while FDA is completing its product reviews.
These are only part of the picture — initiatives that capture headlines. We should not forget that the bulk of FDA employees work hard, often long hours to accomplish the agency’s mission. They do so with little fanfare. However, it is their efforts, as much as the headline initiatives, that assure that our foods are safe and our medical products safe and effective.
And that’s why we are dedicated to increasing the resources and manpower at FDA. On behalf of the Alliance, Ladd and I thank each of you for supporting and participating in this effort.
Note: This week’s analysis and commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA