A Slight Improvement -- But Not Enough!

The Senate Ag/FDA appropriations bill is a slight improvement over the House bill, but neither funds the FDA at a level that reflects the growing responsibilities of the FDA. The Senate bill is $39 million above the FY 16 appropriated level, $29 million above the President’s request, and $6 million above the House level.In both bills, the bulk of the additional funding goes to food safety (+$36 million in the House; +$40 million in the Senate over FY 16 final). The medical products side would receive about a $10 to $12 million increase. Totaling these numbers (food safety + medical products) is larger than the overall increase because the committees accepted some (not all) of the Administration’s proposed administrative savings as an offset.The Senate proposes that the $40 million increase in food safety be divided between $19 million for the National Integrated Food Safety System and $21 million for Import Safety. Apart from food safety, the Senate proposes increases of

• $3 million for animal drug and medical device reviews

• $2 million for precision medicine

• $1 million to evaluate biomarkers for drug development

• $3 million for improved foreign high-risk inspections

• $2 million for pediatric device review

• $1 million for medical device post-market safety activities.

The Senate (and the House) would level-fund the National Center for Toxicological Research by not accepting the Administration’s proposal to cut the Center.Click here to see the proposed FY 17 Budget Authority appropriations for FDA compared to FY 15-16.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.