Advocacy at a Glance

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.

• Appropriations Committee Mark-ups Not Yet Set. The House and Senate are in recess this week, with the Senate returning the week of April 4 and the House returning the week of April 11. So far, neither body has scheduled mark-up for the Agriculture/FDA appropriations bill. If Congress is to keep with its goal of finishing all 12 appropriations bills by September 30 of this year, then subcommittee mark-ups for Ag/FDA will probably need to be scheduled in April and May. In addition to a number of political and procedural barriers to mark-up, we are also told that a proliferation of policy riders on Ag/FDA (as well as L/HHS) are potential impediments to action.

• Dr. Califf Sets Out His Priorities in Blog Post. In a column in FDA Voice, new FDA commissioner Robert Califf discusses his priorities. Foremost, he has committed himself to building the FDA’s staff to improve recruitment, retention, and job satisfaction as part of enhanced scientific decision making. His top programmatic goal is to “rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances.” Among other priorities, he cites: pain and opioid dependency; implementation of the Food Safety Modernization Act; antimicrobial resistance; and precision medicine.

• FDA’s Generics Performance Report. The FDA has released its FY 2015 Generic Performance report that describes investments made and milestones met under the Generic Drug Use Fee Act. FDA asserts that it has now addressed 82% of the backlog that existed when the law was enacted in 2012. Nonetheless, working down the entire generics backlog is considered a major goal for FDA and industry.

• Drug Review Times Halved from 2009 to 2014. According to a report from the California Life Sciences Association and the Boston Consulting Group, average drug review times for new molecular and biologic entities improved from 21 months in 2009 to 9 months in 2014. While all review divisions did markedly better, approval times in cancer, infectious diseases, and rare conditions were faster than in some other therapeutic areas.