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.
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:

  • Going Agile:Revolutionizing Federal Digital Services Delivery

    Here’s one indication that times have changed: Harriet Tubman is going to be the next face of the twenty dollar bill. Another sign of change? The way in which the federal government arrived at that decision.

    Download
  • Cyber Risk Report: Cybercrime Trends from 2016

    In our first half 2016 cyber trends report, SurfWatch Labs threat intelligence analysts noted one key theme – the interconnected nature of cybercrime – and the second half of the year saw organizations continuing to struggle with that reality. The number of potential cyber threats, the pool of already compromised information, and the ease of finding increasingly sophisticated cybercriminal tools continued to snowball throughout the year.

    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
  • GBC Issue Brief: The Future of 9-1-1

    A Look Into the Next Generation of Emergency Services

    Download
  • GBC Survey Report: Securing the Perimeters

    A candid survey on cybersecurity in state and local governments

    Download
  • The New IP: Moving Government Agencies Toward the Network of The Future

    Federal IT managers are looking to modernize legacy network infrastructures that are taxed by growing demands from mobile devices, video, vast amounts of data, and more. This issue brief discusses the federal government network landscape, as well as market, financial force drivers for network modernization.

    Download
  • eBook: State & Local Cybersecurity

    CenturyLink is committed to helping state and local governments meet their cybersecurity challenges. Towards that end, CenturyLink commissioned a study from the Government Business Council that looked at the perceptions, attitudes and experiences of state and local leaders around the cybersecurity issue. The results were surprising in a number of ways. Learn more about their findings and the ways in which state and local governments can combat cybersecurity threats with this eBook.

    Download

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