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.

• Election Results: New Republican Senate Majority, Expanded Republican House Majority. It was a “wave” election that strongly favored Republican candidates in most Congressional races in almost every state. The implications for FDA are discussed in this week’s Analysis and Commentary and were analyzed in last week’s Analysis and Commentary post too.

• Special Post-Election Briefing and Alliance Membership Meeting on November 11. The Alliance will have a post-election briefing on November 11 at 11 a.m which will be followed by an Alliance Membership Meeting.   At the briefing a panel of Congressional experts will provide their analysis of the election results and the potential Impact on FDA and Federal Discretionary Funding.  Attached please find additional details on the event.   To attend, please RSVP by e-mail to Tony Curry. Note: to assure the candor of our speakers, the briefing is limited to Alliance members and is not open to the media.

• FDA Regulations Increased, So Did It’s Responsibilities. A newly released analysis by Mercatus Center at George Mason University concludes that FDA regulatory requirements grew by 15% between 2000 and 2012.  The study is covered in Regulatory Focus. However, the study ignores the context. During those 12 years, FDA’s responsibilities grew by well more than 15% as a result of new laws, globalization, and increasingly complex science. On July 26, 2013, an Alliance Analysis and Commentary blog post took a deeper look at a similar study and found that failures of methodology and context made the conclusions unsupportable.

• Breakthrough Drug Program a Potential Resource Concern. As reported by several news sources, Dr. John Jenkins, head of CDER’s Office of New Drugs has expressed concerns about the resources required to sustain the relatively new breakthough drug program. During his presentation to the National Organization for Rare Disorders, he said that CDER’s commitment to the breakthrough drug program is strong. However, the original thinking was that it would affect a handful of companies/products and could be managed through existing resources. Instead, the program has provided breakthrough designation to more than 60 therapies and involved review of a large number of applications. He was careful not to state that the problem was yet critical, but that the agency could foresee a “tipping point” where it could not give needed attention to all priority applications, as well as public health emergencies such as Ebola.

• FDA: Partnerships Are the Key to Keeping Foods Safe Worldwide. Michael Taylor, FDA Deputy Commissioner for Food and Veterinary Medicines was in China this week for meetings with officials. This gave him an opportunity to lay-out his vision of FDA’s global food safety responsibilities, which are covered in an FDA Voice blog post. His main messages: consumers around the world all want safe foods for their families; partnerships are the best approach to global food safety; and the FSMA framework sets an appropriately tough standard for improving food safety worldwide. FDA also announced that the long-planned expansion of its China office will occur next year. The office will go from four staff to 21, and nine of those would be assigned to food safety.

• Ebola Funding Request Sent to Hill. President Obama has requested an additional $6 billion in emergency funding to expand and accelerate the US effort to combat Ebola. Roughly three-quarters of the money will be for immediate needs and another quarter will be to pre-fund contingency needs. Monies would be allocated to agencies across the government, not just to the Public Health Service agencies. FDA is proposed to receive $25 million to help with the costs of working with vaccine and therapeutic agents for the disease.

• State of Science at FDA Again Under Review.  At Commissioner Hamburg's request, a subcommittee of the FDA Science Board has been formed to review the state of science at FDA, highlighting the current strengths of regulatory science at FDA and evaluating the Agency’s readiness and needs looking forward to future challenges.  The Alliance is greatly interested in this review, which is due this Spring, in light of the importance of the 2008 Science Board Report, which determined that FDA’s science-based mission was at risk because of lack of resources. You can learn more about the report from the FDA Track system if you click here.