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Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products

Posted 03 February 2015 | By Alexander Gaffney, RAC 

Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products

The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced.

Background

The effort, announced on 29 January 2014, is being led by Sens. Lamar Alexander (R-TN) and Richard Burr (R-NC), and is meant to complement similar efforts by the House Energy and Commerce (E&C) Committee.

Read our explainer on the 21st Century Cures Act here.

The HELP Committee has released a report, Innovation for Healthier Americans, meant to outline their topics of interest in the coming debate. The report, with an introduction written by former FDA Commissioner Andrew von Eschenbach, makes the argument that advances in scientific understanding should allow regulators, and FDA in particular, to adopt more tailored approaches to product approval and oversight.

"Government policy can either inhibit or accelerate the next revolution in science and technology," Eschenbach writes. "The time has come to examine whether our nation has the right public policies in place to realize the full promise of the discovery, development and delivery of 21st century medicine."

As with the E&C Committee, the Senate's health oversight board says it wants to assess the current state of FDA regulation in the US. "What works? What's not working? What can we do better?" they ask in their report.

The Big Picture

But if their methods are still unclear, their goal is not: Cutting down on the time it takes to bring new medical products to American patients.

"While the FDA has reviewed drugs in as little as three months, and meets the timelines set for medical device reviews the majority of the time, the inability of medical product developers to predict what questions will be asked during the review forces a multi-year process simply to get an application ready for FDA consideration," the report notes in its introduction. The growing complexity of medical products is likely to further complicate the regulatory review of those same products, the report hypothesizes.

The report goes on to list five areas, organized into general statements, where the Senate hopes to focus its efforts:

  • It costs too much to bring medical products through the pipeline to patients.
  • As science and technology advance, the discovery and development process takes too long for medical products to make their way to patients.
  • FDA’s responsibilities have grown to include many activities unrelated to the core function of regulating medical products to advance the public health.
  • The disparity in scientific knowledge at FDA and the fast pace of biomedical innovation are slowing, and in some cases, stifling, innovation in American medicine.
  • A working FDA is essential to continuing biomedical innovation in the United States and maintaining America’s global leadership in medical innovation.

Specific Focus Areas

The Senate, like the House, seems prepared to dig into specific areas where it believes changes might result in outsized benefits to the regulatory system.

For example, the report identified predictive toxicology as one area where improvements might allow good drugs to succeed more quickly, and for bad drugs to be weeded out earlier in the development process.

The committee's report also takes aim at clinical trials, saying that larger, phase III clinical trials are "not necessarily responsible to today's advanced understanding of medicine and the changing needs of the biomedical industry." The committee said new advances in scientific understanding should allow for smaller and more flexible clinical trials.

Legislators are also eyeing expedited pathways for medical products—an idea that was fleshed out in the E&C's draft of the 21st Century Cures Act—and ways that FDA can hire, retain and best manage its regulatory staff.

Next Steps

The HELP Committee has already announced its plans to move forward with reforming the federal regulatory system for medical products. On 3 February 2014, Sens. Alexander and Patty Murray (D-WA) said they would launch a "bipartisan initiative to examine the process for getting safe treatments, devices and cures to patients and the role of the FDA and the National Institutes of Health (NIH) in that process."

The senators plan to hold a "bipartisan staff working group" in the second week of February 2015, and then a series of hearings starting in March 2015 "that will examine the drug and medical device discovery and development process, and how to better align public policies to support medical innovation while maintaining high standards of consumer and patient safety."

The committee is also accepting public feedback until 23 February 2015.


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