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Regulatory Focus™ > News Articles > New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

Posted 27 April 2012 | By Alexander Gaffney, RAC 

The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint, which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues.

The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation."

While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of translating that research into therapies for patients, and cannot be ignored.

"[U]nnecessary or overly burdensome regulatory barriers must be removed to accelerate the advancement of bioinventions from laboratories to marketplaces while ensuring adequate attention to environmental and health concerns that may be raised by scientists' new facility with biological systems," explained OST.

A key part of OST's bioeconomy strategy, it said, "is to foster the growth of new companies and support established companies by increasing commercialization of promising new technologies and products emerging from research laboratories."

To help bridge the so-called "valley of death" between research and therapies, OST calls for:

  • renewed emphasis on advancing regulatory science
  • leveraging the expertise of scientific experts in the medical device field
  • increased consistency within FDA, fully utilizing the de novo process for low-risk medical devices
  • a risk-based approach to regulating human-subjects medical research
  • further use of parallel reviews between FDA and the Centers for Medicare & Medicaid Services (CMS)
  • the improved regulation of emerging technologies like nanotechnology
  • increased cooperation between FDA and the National Institutes of Health (NIH) to re-purpose existing drug compounds

OST also called for further funding to promote research in key areas, and issues related to regulatory affairs received prominent attention.

OST is calling for the maintaining funding for a joint effort between the US Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency (DARPA) to develop chip-based technologies to predict the effectiveness of drugs and biologics. The project aims to "accelerate drug discovery and development while decreasing the testing of drugs and vaccines in animals," writes OST.

The agency is also pushing for FDA to be turned into "a driver of discovery in development," noting FDA "houses on of the largest known repositories of clinical data, including safety, efficacy and performance information," in addition to postmarketing surveillance data.

"Integrating and analyzing these data could revolutionize the development of new patient treatments and allow researchers to address fundamental scientific questions about how different patients respond to a therapy," said OST. "Harnessing the power of these data will benefit from collaborations to develop new analytical methodologies and better standardization of the data for integration, all while protecting proprietary information"

While the report says FDA must rely on its information technology systems to implement such a transformation, a recent report from the Government Accountability Office (GAO) said FDA's systems, under development for years, are in danger of not being completed. Reporting by The Pink Sheet Daily on 26 April also indicated the Senate appropriations committee has taken notice of that report and is actively looking to "increase their oversight of FDA's information technology investments as the agency strives to remedy deficiencies cited" in the report.

OST's report also calls attention to several advanced projects that could change the face of drug development, including a DARPA project known as the "Living Foundries Program" which intends to harness biology to develop new medicines and medical devices, among other advanced applications.

"This effort seeks to develop the tools, capabilities, and methodologies to create a transformative shift in the ability to engineer biology through the integration of ideas, tools, and approaches from the biological, computational, and engineering fields," explained OST.

Read more:

OST - National Bioeconomy Blueprint Released

OST - National Bioeconomy Blueprint

Regulatory Focus - Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

The Pink Sheet Daily - FDA's IT Systems Painted With Bull's-eye By Senate Funding Panel

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