Among potential stumbling blocks to a timely five-year renewal of the program was whether any significant differences emerge between each chamber's version of the bill, both of which were developed through bipartisan negotiations. Members of the Energy and Commerce Health Subcommittee, which held the seventh hearing this year on the House approach to the reauthorization today, said they had not yet reviewed the newly released Senate version to see if any sharp differences have emerged.
However, passage of the reauthorization through the House could be complicated by a series of partisan fights over provisions members who want to add to that version. For instance, Democrats are pressing for provisions to add medical devices to both the FDA's sentinel review process and require them to add unique identifiers.
Separately, Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) introduced legislation that aims to increase agency transparency and accountability by requiring a series of regularly scheduled reports from the FDA, such as the total time for decisions on all products submitted for marketing approval.