Further harmonization among major regulatory agencies globally will look to focus on pediatric drug studies in 2016, according to a new report from the Tufts Center for the Study of Drug Development.
The report released this week outlines not only what the drug development industry should expect for 2016, but also how regulators will play a major role in keeping drugs safe and in some cases extending marketing exclusivity periods for certain classes of drugs deemed critical, as well as encouraging the development of generic drugs to increase competition and lower costs.
As far as what the regulatory side of the drug development spectrum will focus on, Tufts says that the re-authorization of the Prescription Drug User Fee Act (PDUFA), which will take effect in late 2017, is expected to include regulatory review enhancements to better account for real world evidence and patient-focused drug development, particularly with next generation sequencing and adaptive clinical trials designs.
In addition, the combination of growing antimicrobial resistance and a lack of new antibacterials has spurred US lawmakers to include new incentives for the development of such drugs via the FDA Safety and Innovation Act of 2012, which Tufts says “will bear fruit and new antibacterials will begin to reach the market over the next several years.
“Major regulatory agencies will emphasize harmonization of global activities to coordinate and facilitate pediatric studies, prompted by recent changes in policy that will increase the demand for pediatric patients to participate in clinical trials,” Tufts adds.
Pediatric study plans were introduced in 1997 under the Food and Drug Administration Modernization Act (FDAMA) as a response to low rates of pediatric testing. Later in 2003, under the Pediatric Research Equity Act (PREA), FDA introduced postmarketing requirements for certain drugs to conduct pediatric testing to support indications for which pediatric use was likely. And in 2014, the agency released new recommendations for how pediatric studies should be conducted.
Similarly, in 2013, the European Medicines Agency released a newly revised draft guidance to clarify some of the requirements surrounding the EU’s Pediatric Regulation.
On top of these initiatives, FDA and the National Institutes of Health (NIH) will look to use the Precision Medicine Initiative to identify new disease biomarkers and integrate existing ones into the regulatory process through the FDA’s biomarker qualification program.
FDA in 2016 is also expected to expand and improve its Sentinel Initiative, which helps to evaluate product safety issues.
Tufts CSDD 2016 Outlook Report