• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

Watchdog Report: FDA Lacks Plan to Keep Pace with Medical Devices

by Fred Pennic 06/16/2016 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

FDA Recalls McKesson's Anesthesia Care for False Patient-Matching

Senior members of the Senate health committee today released two separate reports from the government’s independent watchdog finding the Food and Drug Administration (FDA) lacks a clear plan to help the agency keep pace with the science behind the drugs and medical devices it regulates and to ensure its three centers are working together to efficiently review life-saving medical products.

“These reports demonstrate the need for Congress to pass smart laws and then conduct rigorous oversight to ensure that an agency tasked with safeguarding the health of Americans isn’t falling behind. As we work to pass the most important legislation this year in 21st Century Cures, I will also be working to ensure FDA carries out provisions of the 2012 law that were intended to help its centers work together and help the agency keep up with the fast pace of science,” said Senate health committee Chairman Lamar Alexander (R-Tenn.) in an official statement. 

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012 following overwhelming bipartisan support in Congress and required the FDA to develop a plan to ensure the agency is keeping up with the fast pace of science and the new medical products it is tasked with regulating.

To improve the agency’s ability to review groundbreaking drugs and medical devices—for example, combination medical products like a heart stents that also deliver blood thinners to prevent clots —the legislation also required the FDA to develop a strategic integrated management plan (SIMP) to improve coordination between its three centers overseeing medical products: biologics, drugs, and medical devices. Congress included both of these provisions in the 2012 law after hearing from frustrated patients and makers of innovative drugs and medical devices about a slow, unpredictable review process at the FDA.

Report Findings

The first report from the Government Accountability Office (GAO) finds the FDA is not measuring whether or not the agency is making progress in keeping up with the science behind the drugs and devices it regulates—what is called “regulatory science”—nor is it accounting for the $504 million the agency spent from FY2010 – 2014 on regulatory science.

According to today’s report, “FDA does not have the information necessary to track funding and conduct strategic planning agency-wide for its regulatory science priorities because most of the centers and offices did not collect information on the FDA priority areas that were addressed by the projects they funded.” The GAO’s recommendations, which have been endorsed by the Department of Health and Human Services, are to both develop and document measurable goals, including targets and time frames and systematically track funding across its regulatory science priority areas.

The second report finds serious gaps in the FDA’s strategic plan, which was required by Congress in FDASIA to help the agency coordinate between its three centers and bring life-saving drugs and devices to patients more quickly. The GAO found the FDA’s plan “presents high-level information on goals and performance measures for medical product oversight, but lacks detail on how it will be used or implemented.” GAO continued, “The absence of a documented long-term plan for medical product oversight may hinder FDA’s efforts to address emerging issues that require center collaboration, such as access to quality data and developing requirements for combination products … [F]ormal strategic planning is needed for medical products.”

The GAO recommends that the agency use a strategic plan that involves all agencies—especially as America’s researchers are creating new and innovative medical products—adding, “Emerging issues—including increasingly complex medical products such as combination products, the need for integrated information systems, and the increased hiring demands for specific scientific knowledge—go beyond the expertise of a single medical product center and highlight the growing importance of strategic planning across medical products. Advances involving new diagnostic tools, treatments, and cures require collaboration in order to be successful.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: Medical Device

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

 Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care

Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care

Featured Interview

Virta Health CEO: GLP-1s Didn’t Kill Weight Watchers, Its Broken Model Did

Most-Read

Health IT Sector Navigates Policy Turbulence with Resilient M&A

Health IT’s New Chapter: IPOs Return, Resilient M&A, Valuations Rise in 1H 2025

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

CMS Finalizes New Interoperability and Prior Authorization Rule

CMS Proposes 2026 Physician Fee Schedule Rule: Boosting Primary Care, Cutting Waste, and Modernizing Payments

Beyond SaaS: How Agent as a Service is Transforming Healthcare Automation

Beyond SaaS: How Agent as a Service is Transforming Healthcare Automation

New Strategies Needed: No Surprises Act and the Challenges for Payors with Provider Data Inaccuracies

Samsung Acquires Xealth to Accelerate Connected Care Vision

Samsung Acquires Xealth to Accelerate Connected Care Vision

AI Dominates Digital Health Investment in First Half of 2025

Rock Health Report: AI Dominates Digital Health Investment in First Half of 2025

Moving Beyond EHRs: What Lies Ahead for Healthcare Digitization?

AI Agents vs. Chatbots: Understanding Agentic AI’s Role in Healthcare

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |