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.

• Sign Up for Alliance Lobby Day on Wednesday, March 18. In past years, we have managed to visit 50 or more offices on Lobby Day to promote understanding of FDA’s resource needs. To sign up for morning or afternoon meetings (or both), please contact Tony Curry.

• House FDA Appropriations Hearing “Mixed,” Senate Hearing to be March 12. Commissioner Hamburg testified before the House Ag/FDA appropriations subcommittee this week, with results that might be described as “mixed.” On the one hand, Members praised Dr. Hamburg’s leadership and asked few questions that were particularly critical of the agency. On the other hand, there were a number of warnings that FDA would have a hard time justifying an increased appropriation given the very severe spending restraints the subcommittee will be under. The House hearing and prospects for the Senate hearing on March 12 are discussed in more detail in this week’s Analysis and Commentary.

• Fiscal Cliffs Update. As described here, Congress faces a series of “fiscal cliffs” -- where fundamental differences separate the two Houses and the lack of agreement has immediate and serious consequences for the federal budget and prospects for FY 16 appropriations. The first of the cliff challenges -- FY 15 funding for the Department of Homeland Security -- quietly ended this week with the House deciding to pass a clean, full-year appropriations bill, rather than insist on immigration amendments. The next fiscal cliff is the updating of the Sustainable Growth Rate (SGR) formula used to pay Medicare physicians. This week, House Ways & Means Chair Paul Ryan (R, WI) said that a temporary SGR patch should be enacted now and  a permanent fix should wait for more comprehensive budget negotiations later this year.

• GAO vs. FDA on the Safety of Food Imports. In a newly-issued report, the General Accounting Office (GAO) has  criticized FDA for not conducting as many foreign inspections as required by FSMA and for not filling vacancies in FDA’s foreign offices. The agency responded by pointing out the discrepancy between the funding needed to conduct 4,800 foreign food facility inspections (FY 14 FSMA target) and the actual funding FDA received, with which they were able to conduct 1,330 inspections in FY 14. There is also a disagreement between GAO and FDA about the optimum number of inspections necessary to sustain a safe imported food supply.

• Study Quantifies Improvements in Drug R&D Efficiency. A thank you to Dickinson’s FDAweb.com for pointing out a recent analysis in the journal Nature, discussing indicators of drug research and development efficiency at FDA between 2003 and 2013. The authors of the article conclude:

Drugs targeting serious diseases and assigned to special designation programs had higher chances of early approval and also fewer pivotal trials, involving fewer patients. ... Special designation programs were used extensively in the development of cancer drugs and there are still opportunities to increase their use for drugs in other areas. The increase in the proportion of drugs approved at the first review cycle and the decrease in the number of pivotal trials provide evidence of increased efficiency in the development of new drugs in these respects in the period studied. However, the lack of improvement in drug approval timelines and the large increases in pivotal trial size indicate new strategies are needed if efficiency gains related to these indicators are to be achieved.

• Alliance Board Member Quoted on FDA Resource Needs. Alliance co-founder and board member Wayne Pines was quoted by Associated Press in their article on new FDA Deputy Commissioner for Medical Products, Dr. Robert Califf. Pointing to the budgetary challenges facing FDA, Wayne offered this assessment:

It's coming to the point where you can't run the agency anymore if you're getting new responsibilities but without additional funding.

Note:We apologize for a slight delay in posting this information to the Alliance web site.