The U.S. is in need of a modernized process for bringing new medical products and drugs to the market. Let’s explore how Open Outcomes Based Regulation could possibly be the next step in innovative healthcare solutions.
Open Outcomes Based Regulation (OOBR) Defined
Wireless-Life Sciences Alliance (WLSA) has introduced Open Outcomes Based Regulation (OOBR), a redesigned process for reviewing and approving medical products. OOBR aims to create a connected health technologies framework that will improve the regulation of drugs, health IT, and medical devices.
OOBR Goals:
- Save Time
- Save Money
- Save Lives
Why Does the FDA Process Need a Redesign?
- The current drug approval process takes 12-15 years to get from compound discovery to the market.
- Five out of 5,000 drug compounds make it to human testing > One out of those five compounds is approved to be sold on the market
The regulation processes have remained stagnant while technology, medical knowledge, and health behavior have been rapidly advancing.
Current vs. Proposed FDA Medical Product Approval Process (Trials)
Current Process
- Phase I Trials – Safety (about 1.5 years)
- Phase II Trials – Safety and Efficacy (about 2 years)
- Phase III Trials – Efficacy and Safety with Randomized Clinical Trials (about 3.5 years)
- Phase IV Trials – Post-Market Testing (ongoing)
Proposed Process
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- Phase I Trials – Safety (about 1.5 years)
- Phase II Trials – Safety and Efficacy (about 2 years)
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- Phase III Trials – Efficacy and Safety with Real Market Testing
- Phase IV Trials – Post-Market Testing (ongoing)
Benefits of OOBR:
- Timely – Push favorable products to the market more quickly
- Continuous – Continue to collect data and evaluate the product once it is on the market
- Open – Provide transparent data to the healthcare community so they can make informed purchasing and usage decisions
- Economical – Save money on pre-market studies, quickly identify faulty products, and reallocate funds to a different product
In What Cases Is OOBR Best Applied?
Example: Ebola Vaccine – High Risk/High Need
There are currently two Ebola vaccines in the midst of clinical trials, and so far they have not posed any harm to humans. It would make sense to shorten the approval process for this specific vaccine because it has such a high patient need.
OOBR Breakdown 1
Five Steps of the OOBR System:
- Medical product approved by agency or self-certified (based on defined categories)
- Possible pre-market clinical research
- Initial market authorization to estimate the likelihood and degree of unanticipated risks
- Product enters market and data about safety and efficacy is collected and made available to researchers for publication
- Revisions of marketing approval and labeling of product based on data collected
- Data access is granted to customers and users to make informed purchasing decisions
OOBR Analogy: Car Manufacturing Regulation
The automotive industry uses a regulatory model similar to that of OOBR and has seen tremendous benefits. Over a 50-year period, the manufacturing and approval process has sped up, allowing cars to become cheaper, safer, and more fuel efficient. See the safety progress in the graph below:
Traffic Fatalities per 100 Million Vehicle Miles of Travel in the U.S.
Suggestions for Implementing OOBR
- Make it Voluntary: Start implementing OOBR as a voluntary program for manufacturers.
- Identify Need: Try the OOBR process out with products that have moderate to high risk but also high patient need.
- Communicate Results: Get manufacturers on board to continue sharing data related to product utilization, efficacy, and outcomes for continuous improvement.
- Address Liability: Decide who would accept legal responsibility for the safety and efficacy of a product—it would likely be the clinical provider.
Sources:
HTTP://WIRELESSLIFESCIENCES.ORG/WHAT-WE-DO/POLICY-INITIATIVES/OOBR/
FILE:///C:/USERS/MARIA/DOWNLOADS/WIRELESS-LIFE_SCIENCES_ALLIANCE_WLSA_CTIA_COMMENTS_ON_FDASIA_REPORT_FINAL_070214.PDF
http://www.fdareview.org/graphics/graph1.jpg
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
http://www.who.int/medicines/emp_ebola_q_as/en/
http://www.ofm.wa.gov/budget/pog/indicators/mobility/mobility_09a.asp
