Combination Products: an Expanding Area of FDA Responsibility and more

Oct 16

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Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

Congress in Recess; No Progress on Appropriations. Congress was in recess this week; scheduled to return next week. Meantime, the government is operating under a Continuing Resolution that expires on December 11. Under the FY 16 CR, FDA and other federal agencies have available only the pro-rated portion of their FY 15 spending level. In addition, no new program starts are permitted. The hope remains that a budget deal can be worked out -- perhaps in conjunction with a bill to raise the federal debt ceiling -- that would make additional funds available for non-defense discretionary programs, such as the FDA. For what else is happening in DC that matters to the FDA, see this week’s Analysis and Commentary.

Senate HELP Committee to Consider FDA Commissioner Nominee Before Thanksgiving Recess. Dr. Robert Califf, nominated to be the next FDA commissioner, is reportedly making good progress and his confirmation hearing and committee vote may occur before Thanksgiving. Depending on timing, he might then be considered by the Senate before or after the recess. Newspaper accounts say that Senator Bernie Sanders will not vote for Califf, but it is unclear whether he might try to place a hold on the nomination.

Combination Products: an Expanding Area of FDA Responsibility. Combination products are the combination of two or more of drugs, devices, and/or biologics. From a product development perspective, it is a burgeoning area, meaning more activity in the sometimes difficult space among the agency’s authorities. FDA Voice, the agency’s blog, has an excellent review of agency activity and plans in the combination products area.

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