A discussion draft of the Cures reforms, which are likely to change the drug and device development process, is expected to be rolled out in January, leading to the passage of comprehensive legislation later in the year, said John Manthei, partner and global co-chair of Latham & Watkins' health care and life sciences practice.
"This will be an ambitious undertaking," he
said of the Cures initiative.
"I think the energy from both the Republicans and Democrats is there.
The initiative has enjoyed strong bipartisan support in the House Energy and Commerce (E&C) Committee, as well as in its Health Subcommittee.
As a result of that support, Manthei
predicted 2015 will see the broadest scope of FDA
reforms ever for a year in which Congress isn't re-authorizing the five-year drug and device user-fee package.
Some of the measures likely to be included in the reforms include modernization of clinical trials, use of real world evidence in drug and device development, streamlined reviews of combination products, more expedited approval paths, improved scheduling of controlled substances, and use of biomarkers and statistical models.
also expects Congress will consider how and when the FDA
should regulate phone apps as medical devices.
Along with those reforms, he
thinks the new Republican-controlled Congress
will exercise more oversight of the FDA
, seeking greater transparency, predictability and accountability in the agency's dealings with industry and in its handling of resources.
Over the past few years, the FDA
has seen significant funding increases, largely due to new and expanded user fees.
The 114th Congress
, which will be seated in January, will take a hard look at how the agency is using that money, especially when it comes to hiring the staff needed for its increased authorities, Manthei
said during a media briefing on the impact Tuesday's election could have on the life sciences sector.
With the Republicans at the Senate helm, Manthei
Adding to their loss will be the departure of their experienced staff, Manthei