FDA Reform Fails

September 9, 1996
THE DAILY FED

FDA Reform Fails

A House Republican source close to negotiations with the Clinton administration over legislation to reform the FDA drug approval process last week attributed the failure of talks to a growing reluctance by the administration and House Democrats to reach agreement. The source noted "a chill in the air" in the period heading up to the Democratic National Convention in August. House Commerce Committee aides had been in negotiation with HHS staff since July. The measure, which the Commerce panel has not yet marked up, would partially privatize the approval process for drugs and medical devices. Rep. James Greenwood, R- Pa., leader of the House Commerce FDA reform task force, last week said the issue is dead this year.

But other sources disputed the assertion that the administration and Democrats were reluctant to reach agreement. One source said the Democrats are willing to talk, but have had no contact from Republicans. Another source said the administration has no control over whether the two sides will meet and that Republicans have declined to call any new meetings since Congress returned from its August recess. The source said the talks had been making progress, but Commerce Committee GOP staff refused to sign off on issues that had been resolved until negotiators worked out a final agreement, adding negotiators remained far apart on "big-ticket" items. One House source said a bill still is possible, but it would have to come from the Senate.

A spokesman for Senate Labor and Human Resources Chairwoman Kassebaum said Kassebaum is still working to get a time agreement for floor consideration of FDA reform legislation approved by her committee. However, Labor and Human Resources ranking member Edward Kennedy, D-Mass., has spoken out strongly against the measure, and a Kennedy spokesman said the tight FY97 appropriations schedule may rule out floor consideration of FDA legislation. The House GOP source argued that even without a bill, the FDA reform effort has been a partial success because the political attention forced the agency to make internal reforms and speed up the approval process. The source added that with so much progress, House Republicans may be able to pass a stripped-down version of the bill.

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 G Suite

    Cross-Agency Teamwork, Anytime and Anywhere

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

    Download
  • 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
  • Federal IT Applications: Assessing Government's Core Drivers

    In order to better understand the current state of external and internal-facing agency workplace applications, Government Business Council (GBC) and Riverbed undertook an in-depth research study of federal employees. Overall, survey findings indicate that federal IT applications still face a gamut of challenges with regard to quality, reliability, and performance 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.