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.

•  Senate Appropriations Ranking Democrat. For the new Congress, the ranking Democrat on the Senate Agriculture, Rural Development and FDA appropriations subcommittee with be Jeff Merkley of Oregon. He was a member of the subcommittee in the last Congress and the Alliance has worked well with his office in the past. The Republicans have not yet announced who will chair the subcommittee.

• Food Safety Regulatory Agenda for 2015. In late November, the Office of Management and Budget released its Regulatory Plans for 2015. As noted by Food Safety News: five of the seven major Food Safety Modernization Act (FSMA) rules are scheduled to be finalized by the end of 2015. The rules regarding preventive controls for human food and preventive controls for animal food will be finalized by August 30, and the rules for produce safety, the foreign supplier verification program, and third-party accreditation will be finalized by October 31. (The other two rules regarding sanitary transportation and intentional adulteration will be finalized by March 31, 2106, and May 31, 2016, respectively.)

• Drug Approvals Hit 18-Year High. As has been widely reported over the last 2 weeks, the FDA approved 41 novel medicines in 2014. This was the most in 18 years and compared favorably to the 27 approved in 2013.

• FDA’s Mini-Sentinel Program to Scale Up. After a 3-year trial of its active safety monitoring system, known as mini-sentinel, a full-scale Sentinel program is being launched.  What distinguishes the Sentinel project is its core data set: access to electronic healthcare data of more than 170 million Americans. FDA has focused on methodologies for evaluating data trends and used the data to evaluate possible safety issues. Because of limitations in the data, safety signals are treated as the basis of inquiry, rather than a definitive statement about whether safety problems exist.

• Enforcement of DCSCA Delayed. Key deadlines under the Drug Supply Chain Security Act (DSCSA) have, in effect, been delayed until May under an FDA decision not to enforce the new law until then. This is seen as a reflection of the complexities of making the law work and FDA’s willingness to be flexible on the deadlines in order to ensure a high level of initial compliance. The FDA guidance can be found here.