Senate gears up to debate FDA drug safety system

Drug safety legislation up for debate in the Senate Monday afternoon would require pharmaceutical companies and the Food and Drug Administration to pool public and private reports of adverse drug reactions into one FDA computer system.

The proposal is part of a bill that would reauthorize and amend a program that collects fees from drug manufacturers for drug reviews and safety evaluations.

Negotiations to divvy up system responsibilities are ongoing, according to Craig Orfield, spokesman for Sen. Mike Enzi, R-Wyo., ranking member on the Senate Health, Education, Labor and Pensions Committee. The committee approved the program's reauthorization earlier this month.

"It is a work in progress. The development of the system, that burden, would be placed on the FDA," Orfield said. The FDA would be collaborating with private entities, as well as academic institutions, to aggregate mainly pre-existing data. It is anticipated the system would be operational within two years of the bill's enactment, he said. Up to $30 million in appropriations would go toward funding the project.

While many agree that additional drug safety surveillance is needed, the design of the system has watchdog groups concerned.

Arthur Levin, director of the nonprofit Center for Medical Consumers, said: "You can't prove causality by data mining. All you're doing is identifying [red flags]. Then you've got to go figure out the connection."

And he is skeptical that $30 million is enough to cover the cost of staffing, computational programming and extraction of useful data. "This may be a good first step. . .but it certainly doesn't go far enough. Much more has to be done," Levin added, saying that the "much more" has to do with where the analytic piece would be housed and where it would be paid for.

John Pippin, a senior medical and research adviser at the Physicians Committee for Responsible Medicine and a cardiologist, said, "The FDA has not yet shown the ability to establish effective computer-based methods. He cited the recent uncovering of a November 2006 report that detailed the FDA's mismanagement of an upgrade to its computerized adverse-event reporting system, which FDA staff use for post-marketing drug safety inspection. The system "was bungled, leading to cost overruns and major delays in implementation," he said.

Earlier this month, Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said the industry wants drug review to be electronic from creation in the lab to sale on pharmacy shelves. As of Monday morning, PhRMA was not taking a position on specific provisions in the new legislation.

PhRMA President and CEO Billy Tauzin said in a statement on Friday, "Significant increases called for in PDUFA funding proposed by the FDA would provide the resources necessary to improve and modernize the agency's already strong drug safety monitoring system."

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

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

  • Sponsored by G Suite

    Cross-Agency Teamwork, Anytime and Anywhere

    Dan McCrae, director of IT service delivery division, National Oceanic and Atmospheric Administration (NOAA)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.


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