Today, the Senate passed the FDA user fee bill (S. 3187), and I was happy that it included provisions that enhance oversight at the FDA so that life-saving drugs and medical devices may reach the patients who need them as quickly as possible. Recent GAO reports have indicated that there is an opportunity to improve FDA’s accountability for meeting user fee performance goals so that Americans have access to the latest, most-effective medical breakthroughs.
The FDA user fee bill included an amendment that I co-sponsored along with Senator Tom Coburn to require FDA to conduct an independent management review of all of its drug review and approval processes. This provision was included in the PATIENTS’ FDA Act, legislation I introduced earlier this year with Dr. Coburn. This amendment would provide for an outside, independent entity to assess the drug review and approval processes at FDA to increase efficiency and timeliness of drug reviews at the agency. Just last week, the Government Accountability Office (GAO) released a report stating that not all FDA employees were evaluated on their role in meeting negotiated user fee performance goals to ensure timeliness in the medical product review process. We owe it to patients to ensure that FDA’s pathways and processes allow for the latest safe and effective breakthrough therapies to reach patients as soon as possible, and this amendment will inform FDA and Congress about how to improve efficiency in the entire drug review and approval process.
In addition to this amendment, I am pleased that language I authored with Sen. Bennet was included in the bill earlier this week that seeks to establish a framework for a uniform, national traceability system to help ensure the integrity and security of the pharmaceutical drug supply chain. To read more about that amendment, click here.