The Bipartisan Policy Center urges Congress to take up three priorities in order to bring new, safe and effective treatments and cures to patients, according to an announcement.
The most recent announcement is a continuation of the recommendations the center made in March in which it kicked off a five-point "FDA: Advancing Medical Innovation" initiative with similar language to the 21st Century Cures Act. That legislation passed the House in July and moved to the Senate, which is expected to craft its own bill.
The BPC's three recommendations:
- Improve scientific expertise and resources at the U.S. Food & Drug Administration
- Enhance health IT interoperability and increase regulatory clarity
- Expand the use of data and development tools to improve medical product development and FDA approval processes
For the latter, it urges acceptance of "real world evidence" drawn from claims, clinical and patient-generated data, and biomarkers to improve the development and delivery of drugs and devices. It also calls for incorporating patient perspectives into benefit-risk assessments.
The BPC had similar themes in a July report.
In September, the FDA set up a panel to provide patient input on the use and regulation of medical devices, though it said, "patient preference information will not be used to justify approval of unsafe or ineffective devices."
Despite the calls to modernize device and drug development in the 21st Century Cure Act, critics have raised questions about its potential privacy pitfalls and provisions that might make the approval process less safe.
To learn more:
- read the announcement