Tech problems hamper drug agency, report says

Severe weaknesses in information technology are hampering the Food and Drug Administration's regulatory role, with some computer systems unable to distinguish between different forms of common chemical compounds like salt, an advisory panel said Monday.

"The IT situation at FDA is problematic at best -- and at worst it is dangerous," according to a report released by the FDA Science Board Advisory Committee.

Many systems are obsolete or failing, "and even e-mail systems are unstable," the report said. "Not surprisingly, it has been reported that during a 2007 E. coli outbreak due to contaminated spinach, the FDA's response was hampered by outages in its e-mail systems."

Inspectors' reports are still handwritten, and the system for managing imported products cannot communicate with Customs and Border Protection and other government systems, the report said. Regulators often miss important product arrivals because the systems cannot distinguish, for example, between road salt and table salt.

The committee issued the report detailing common, recurring gaps in the agency's science and technology that are interfering with the ability to regulate prescription drugs, medical devices and cosmetics, among other items. The evaluation marked only the second time FDA has been reviewed as a whole organization.

"The bottom line is that demands at FDA have soared, resources have not," said committee member Gail Cassell, Eli Lilly's vice president for scientific affairs. Those demands include the globalization of the industries that FDA regulates and the complexity of products submitted for approval.

Cassell said FDA regulates 25 cents of every consumer dollar spent in this country, or $1 trillion in consumer products, but Congress funded FDA at only $1.6 billion for fiscal 2007.

She noted that the report was not supposed to make recommendations about resources. "It is true we overstepped our charge and were forced to look at resources."

FDA data currently reside in large storage rooms "sequestered in piles and piles of paper documents," and there are no backup copies, according to the report.

Report co-author Dale Nordenberg, a former information management chief at the Centers for Disease Control and Prevention, said there has been "some important progress -- perhaps too slow -- by very competent people at the agency." Namely, he said, the new chief information, chief operating and chief technology officers have strong track records at other agencies.

"Investment in the IT arena would be capable of being managed at the FDA" and would strengthen the agency's ability to execute its regulatory mission, Nordenberg added.

The report also found FDA to be grossly understaffed. The committee recommended enlarging FDA's workforce and employing technology to reduce workloads.

For example, the FDA might want to place sensing devices at manufacturing plants, in rail cars, and on product packaging to detect purity and contamination. "The extraordinary number of sites that must be monitored and the dearth of inspectors translate into the FDA's inability to fulfill its quality assurance mandate," the report said.

Stay up-to-date with federal news alerts and analysis — Sign up for GovExec's email newsletters.
FROM OUR SPONSORS
JOIN THE DISCUSSION
Close [ x ] More from GovExec
 
 

Thank you for subscribing to newsletters from GovExec.com.
We think these reports might interest you:

  • Sponsored by Brocade

    Best of 2016 Federal Forum eBook

    Earlier this summer, Federal and tech industry leaders convened to talk security, machine learning, network modernization, DevOps, and much more at the 2016 Federal Forum. This eBook includes a useful summary highlighting the best content shared at the 2016 Federal Forum to help agencies modernize their network infrastructure.

    Download
  • Sponsored by CDW-G

    GBC Flash Poll Series: Merger & Acquisitions

    Download this GBC Flash Poll to learn more about federal perspectives on the impact of industry consolidation.

    Download
  • Sponsored by One Identity

    One Nation Under Guard: Securing User Identities Across State and Local Government

    In 2016, the government can expect even more sophisticated threats on the horizon, making it all the more imperative that agencies enforce proper identity and access management (IAM) practices. In order to better measure the current state of IAM at the state and local level, Government Business Council (GBC) conducted an in-depth research study of state and local employees.

    Download
  • Sponsored by Aquilent

    The Next Federal Evolution of Cloud

    This GBC report explains the evolution of cloud computing in federal government, and provides an outlook for the future of the cloud in government IT.

    Download
  • Sponsored by Aquilent

    A DevOps Roadmap for the Federal Government

    This GBC Report discusses how DevOps is steadily gaining traction among some of government's leading IT developers and agencies.

    Download
  • Sponsored by LTC Partners, administrators of the Federal Long Term Care Insurance Program

    Approaching the Brink of Federal Retirement

    Approximately 10,000 baby boomers are reaching retirement age per day, and a growing number of federal employees are preparing themselves for the next chapter of their lives. Learn how to tackle the challenges that today's workforce faces in laying the groundwork for a smooth and secure retirement.

    Download
  • Sponsored by Hewlett Packard Enterprise

    Cyber Defense 101: Arming the Next Generation of Government Employees

    Read this issue brief to learn about the sector's most potent challenges in the new cyber landscape and how government organizations are building a robust, threat-aware infrastructure

    Download
  • Sponsored by Aquilent

    GBC Issue Brief: Cultivating Digital Services in the Federal Landscape

    Read this GBC issue brief to learn more about the current state of digital services in the government, and how key players are pushing enhancements towards a user-centric approach.

    Download
  • Sponsored by CDW-G

    Joint Enterprise Licensing Agreements

    Read this eBook to learn how defense agencies can achieve savings and efficiencies with an Enterprise Software Agreement.

    Download
  • Sponsored by Cloudera

    Government Forum Content Library

    Get all the essential resources needed for effective technology strategies in the federal landscape.

    Download

When you download a report, your information may be shared with the underwriters of that document.