recommended reading

FDA says border check system back on track

A system to aid the examination of food and drug imports will be running nationwide by the end of this year after a software glitch held it up for months, Food and Drug Administration Commissioner Margaret Hamburg told Congress on Wednesday.

But she said the cuts being made to her agency will be difficult to absorb, and Democrats attacked Republicans who have forced the cuts as part of a deal to keep the government running.

Hamburg testified before the House Energy and Commerce Oversight and Investigations Subcommittee on a new FDA system that aims to check the safety of the ever-expanding food and drug imports coming into the country. Hamburg said the United States is expected to get 24 million shipments of FDA-regulated products this year, up from just 6 million shipments 10 years ago.

The data system, called PREDICT, allows FDA staff to scan imports as they come into the United States, and check against FDA databases to instantly see who the manufacturer is, the country of origin, and if the product or producer has a history of recall. It also "red flags" high-risk imports for FDA staff to scan.

Due to the volume of imports, FDA cannot scan all food and drugs coming into the country. Before PREDICT, officials used what they called educated guesses and random selections to identify dangerous products.

Hamburg said the implementation of PREDICT had been stopped for several months due to a technical glitch. She said the agency identified a particular piece of software that was slowing down the process, which has since been resolved. When asked if the program would be running nationwide by the end of 2011, Hamburg said "that is our absolute goal."

"At this rate, it would take FDA over five years to deploy PREDICT in the remaining 16 FDA districts," said Oversight and Investigations Subcommittee Chairman Cliff Stearns, R-Fla. "I don't see any reason not to push more aggressively for its immediate deployment nationwide."

PREDICT is operating in Los Angeles, New York, Seattle, and San Francisco, covering 40 percent of the shipments into the country, and Hamburg said it would be rolled out in Florida and San Juan this month, covering 50 percent of imports.

Democrats criticized Republicans for demanding the FDA improve food and drug safety, while proposing to slash its budget. The fiscal 2012 budget plan from House Budget Chairman Paul Ryan, R-Wis., which the House is likely to adopt this week, proposes lowering funds for non-security agencies like the FDA to fiscal 2008 levels and below.

"It takes chutzpah to haul the FDA commissioner up here and grill her about why FDA is not doing more to keep the food and drug supply safe ... while simultaneously passing a budget that takes away the resources she needs to do her job," said Energy and Commerce ranking member Henry Waxman, D-Calif.

When asked by Rep. Jan Schakowsky, D-Ill., what impact the proposed 2012 funding reduction would have on the agency, Hamburg said it would be "enormously difficult to absorb."

Hamburg was repeatedly asked if the FDA needs greater authority to regulate food and drugs. Hamburg said the FDA needed the ability to issue a mandatory recall of drugs, a power the agency just got to recall tainted food products in the 2010 food safety law. Hamburg also said the agency needed the authority to destroy counterfeit or tainted products that are shipped into the country. The FDA currently can only send back unfit products, leaving open the possibility that they could be shipped back later.

Threatwatch Alert

Network intrusion / Stolen credentials

85M User Accounts Compromised from Video-sharing Site Dailymotion

See threatwatch report

JOIN THE DISCUSSION

Close [ x ] More from Nextgov
 
 

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

  • Data-Centric Security vs. Database-Level Security

    Database-level encryption had its origins in the 1990s and early 2000s in response to very basic risks which largely revolved around the theft of servers, backup tapes and other physical-layer assets. As noted in Verizon’s 2014, Data Breach Investigations Report (DBIR)1, threats today are far more advanced and dangerous.

    Download
  • Featured Content from RSA Conference: Dissed by NIST

    Learn more about the latest draft of the U.S. National Institute of Standards and Technology guidance document on authentication and lifecycle management.

    Download
  • PIV- I And Multifactor Authentication: The Best Defense for Federal Government Contractors

    This white paper explores NIST SP 800-171 and why compliance is critical to federal government contractors, especially those that work with the Department of Defense, as well as how leveraging PIV-I credentialing with multifactor authentication can be used as a defense against cyberattacks

    Download
  • Toward A More Innovative Government

    This research study aims to understand how state and local leaders regard their agency’s innovation efforts and what they are doing to overcome the challenges they face in successfully implementing these efforts.

    Download
  • From Volume to Value: UK’s NHS Digital Provides U.S. Healthcare Agencies A Roadmap For Value-Based Payment Models

    The U.S. healthcare industry is rapidly moving away from traditional fee-for-service models and towards value-based purchasing that reimburses physicians for quality of care in place of frequency of care.

    Download
  • GBC Flash Poll: Is Your Agency Safe?

    Federal leaders weigh in on the state of information security

    Download

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