House investigates FDA IT shortfalls; AdvaMed calls for support
The House Energy & Commerce Oversight and Investigations Subcommittee held a hearing on the report, "Science and Mission at Risk: FDA's Self-Assessment,” which has not been publicly released by FDA, but is referenced in a letter to General Accountability Office (GAO) Comptroller General David M. Walker from Sen. Ted Kennedy, D-Mass., and Rep. Henry Waxman, D-Calif., chairman of the House Committee on Oversight and Government Reform. The two lawmakers are seeking an investigation into FDA's resources, staffing and budget shortfalls.
In the letter, Kennedy and Waxman said they are concerned that FDA's budget has not kept pace with inflation and that a lack of skilled personnel hampers the agency's mission of regulating foods and critical medical devices such as pacemakers and hearing aids.
They also criticized the agency's IT infrastructure, which the Science Board called a "source of risk" at FDA's five centers: Biologics Evaluation and Research; Drug Evaluation and Research; Devices and Radiological Health; Food Safety and Applied Nutrition; and Veterinary Medicine.
According to the Science Board report, Kennedy and Waxman said that the FDA suffers from "critical capability gaps" because it has been unable to modernize its IT systems. They cited the following from the report:
- FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate;
- The agency cannot provide the information infrastructure support to regulate products based on new science;
- The agency’s IT infrastructure is obsolete, unstable and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services; and
- The IT workforce is insufficient and not optimally organized.
Following the hearing, AdvaMed the "Alliance for a Stronger FDA," a partnership with patient groups, consumer advocates, public health organizations and companies committed to ensuring that FDA has the resources it needs to meet its public health mandate.
“The FDA has long been considered the world's standard bearer for safety, but critical steps must be taken to ensure that continues in this period of limited resources and additional responsibilities,” said Stephen J. Ubl, president and CEO of AdvaMed.
Ubl said that FDA should undertake a concerted review of its many activities to make sure it is focusing its time and resources on the areas that are likely to have the most significant impact in improving patient care.
Conversely, Ubl added that the FDA should also determine which of its activities have little or no impact on its mission and could be scaled back without adversely affecting the public health and safety. He said that the FDA should promote improvements to programs, such as those that were included in the FDA Amendments Act of 2007, that rely on FDA trained and accredited outside third parties to perform specific which functions.
“We are committed to working with FDA to identify ways the agency can use its available resources as effectively and efficiently as possible,” he added.