Committee’s Bipartisan FDASIA, Which Was Signed into Law Last Congress, Required GAO Audit of Drug Shortages
WASHINGTON, DC – The House Energy and Commerce Health Subcommittee, chaired by Rep. Joe Pitts (R-PA), today heard from the Government Accountability Office (GAO) and the Food and Drug Administration (FDA) regarding the ongoing threat of drug shortages and what steps have been taken by FDA to address this issue, particularly after the enactment of the bipartisan Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA required GAO to compile a report on drug shortages and the role of FDA in resolving them. This report was released today in conjunction with the hearing. Marcia Crosse, Health Care Director at GAO and Douglas Throckmorton, M.D., Deputy Director of Regulatory Programs at FDA, provided testimony.
Chairman Joe Pitts (R-PA) explained, “In recent years, we have seen a dramatic increase in the number of drug shortages in the United States, particularly with generic sterile injectable drugs. While the number of new shortages dipped in 2012 and 2013, the total number of ongoing shortages has continued to increase. This is unacceptable. Numerous drugs have remained on FDA’s shortage list for some time. What is the agency doing to help address these situations? Recent news reports have highlighted shortages of oncology products, parenteral nutrition products, and even common, yet critically important saline solutions. Such shortages lead to delays in treatments, rationing of care, and higher costs. They can also pose greater risk to patients in the form of medication errors and as providers are forced to seek alternative treatments.”
In summarizing GAO’s report to Congress, Dr. Crosse testified, “Based on our work, we have identified two actions that we recommend the Commissioner of FDA take to enhance its oversight of drug shortages:  [D]evelop policies and procedures for the use of the existing drug shortages database (and, ultimately, the new drug shortages information system) to ensure staff enter information into the database in a consistent manner and to ensure the accuracy of the information in the database; and  [C]onduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.”
Dr. Throckmorton explained some steps FDA has taken to address shortage, stating, “In appropriate cases, temporary exercise of regulatory flexibility has proven to be an important tool in ensuring access to treatment options for health care practitioners and patients in critical need.” Additionally, Throckmorton also testified that the agency, “can and does take a variety of actions to mitigate or prevent shortages [including:] Expedite FDA inspections and reviews of submissions from manufacturers attempting to restore production,” and “Expedite FDA inspections and reviews of submissions from competing manufacturers who are interested in starting new production or increasing existing production of products in shortage.”
Questions remain about what shortages FDA was able to prevent and what steps it took to prevent those shortages. The details of the expediting review process and regulatory flexibility remain unclear, adding uncertainty in the industry.
As Rep. Renee Ellmers (R-NC) said, “I appreciate the efforts of the FDA to address this shortage, but it appears that they are only addressing the symptoms and not the real causes.”
Full committee Chairman Fred Upton (R-MI) said, “Our work will continue until all patients receive the medications they need and the peace of mind they deserve.”