The Bipartisan Policy Center is pushing Congress to take all sorts of policy actions to speed new drugs and medical devices to patients who need them sooner rather than later.
The nonprofit Washington think tank is offering its input in a report released July 27, hot on the heels of the similarly concerned 21st Century Cures Act, which easily passed in the House on July 10 (344-77) and now awaits consideration in the Senate.
The BPC report overlaps with the legislation on many points while also making 50 or so suggestions for new measures.
These include nine recommendations on improving the interoperability of health IT, such as:
- “Federally adopted standards should include those required for accurate identification and matching of patient data, provider identification, transport, terminologies, clinical models, clinical data query language, security and application interfaces”; and
- “To assure that federal agencies comply with federal standards, require each federal agency to report annually on its compliance with federally adopted standards and require the Government Accountability Office to issue a report, every two years, on federal compliance with such standards.”
Bill Frist, MD, the retired Tennessee GOP senator and cardiothoracic surgeon who was Senate majority leader, spoke at a July 27 press briefing held to publicize the release of the report.
“Under this whole area of improving the medical product development process, we’ve got to improve the interoperability of health information technology,” said Frist, a co-chair with former Congressman Bart Gordon (D-Tenn.) of the BPC project that created the report.
“We all know that [interoperability] has become the foundation not only for improving the medical product development process but also for other aspects of healthcare,” Frist added, “including delivery, including payments and strategies for supporting and empowering the patient.”
The report addresses “a very challenging and very critical set of issues,” said Mark McClellan, MD, PhD, the former FDA commissioner and CMS administrator who is now director of the Brookings Institution’s Health Care Innovation and Value Initiative. “But we have some real opportunities to turn much of the increasing electronic data that’s becoming available into better evidence and a whole set of tools for giving FDA more resources and support to get there.”
McClellan was one of several advisors who both consulted on the drafting of the report and spoke at the briefing.
Another was Marc Boutin of the National Health Council.
“As the CEO of an organization that represents more than 133 million people with chronic diseases and disabilities, this report that we are releasing today hits really close to home,” said Boutin. “The report recognizes the importance of bringing patient perspectives into both the development and approval processes.”
Boutin stressed that the report’s recommendations in this area include improving and expanding the use of patient reported outcomes in the drug development process and assuring the incorporation of patient perspectives into benefit-risk assessments.
“These recommendations will help us understand what is important to the patient, include that information [in clinical trials], enhance our patient reported outcomes and allow us to develop better research questions for clinical trials that are more powerful to the patient,” Boutin said.
The original sponsors of the House “Cures” bill, Republican Fred Upton of Michigan and Democrat Diana DeGette of Colorado, have said they hope the Senate moves quickly enough with its version to have legislation before President Obama by the end of this year.
To read the executive summary of the BPC report, “Advancing Medical Innovation for a Healthier America,” along with supporting materials, click here.