Ensuring that the FDA prioritizes inspections of overseas device manufacturers is one of the many tasks the House and Senate direct the agency to undertake in their respective fiscal 2016 funding bills and reports.
For example, China takes center stage in the report of the Senate bill, S.1800, which calls for stepped up efforts to ensure the safety of products imported from that country. “The Committee is concerned about the FDA’s ability to keep pace with the exporter universe and volume of exports,” the report says. It praises the agency for its move toward a targeted, risk-based approach to inspections, adding that funds provided through the China Safety Initiative should boost onsite verification support.
The Senate report also trumpets the advantages of in silico trials, which use computer models to predict how devices will behave when deployed in the general population. “In silico trials may potentially protect public health, advance personalized treatment, and be executed quickly and for a fraction of the cost of a full scale live trial,” according the bill’s report.
In addition, the Senate report praises the nine FDA-funded Pediatric Device Consortia for helping develop more than 450 proposed pediatric medical devices since 2009. These devices help meet unmet needs in this patient population. The report calls on the agency to fund the program “at the highest possible level within available resources” and at least at the same level as last year.
The House bill, H.R. 3049, and its accompanying report, H. Rept. 114-205 do not mention any of these initiatives involving device manufacturers. However, the House is asking the FDA to approve a change to the mammogram patient and physician reports to include information on breast density. The request comes four years after the agency’s National Mammography Quality Assurance Advisory Committee approved this measure. The House report calls on the FDA to detail progress made no more than 60 days after the act goes into effect.
The Senate report also touches on this topic, but does not provide a timeframe for completing the task.
In addition, the House report takes the FDA to task for not moving forward on guidance issued in December 2011 intended to help the agency in examining policies for off-label uses of approved and investigational devices. In June 2014, the agency responded to two petitions requesting clarification onregulations regarding communications related to investigational new devices and potential off-label uses. The FDA promised by the end of that calendar year to issue guidance addressing, among other things, the distribution of scientific and medical information on unapproved new uses.
The House report orders the FDA to address the issue “comprehensively” and to complete guidelines within 60 days of act going into effect.