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.

• Ebola: FDA On the Job. Most of the news stories on Ebola (both positive and negative ones) have focused on CDC's and NIH’s roles in combating the current outbreak. This is as it should be. Nonetheless, FDA’s role is substantial, as described by FDA Commissioner Hamburg in her blog column on the FDA Voice site. She reports that more than 250 FDA staffers have been involved, working through the agency’s internal Ebola Task Force. Activities range from intensive work with drug and vaccines companies, to coordination with other national and international agency, to a small contingent of FDA staff who will shortly be on the ground in West Africa as part of the Public Health Services’ medical emergency response team.

• Ebola: Priority Review Vouchers, Call for More Resources. Senators Harkin and Alexander (respectively chair and ranking member of the Senate HELP committee) are proposing that Ebola be added to the existing list of neglected tropical diseases for which an approved therapy or vaccine qualifies a company to receive a priority review voucher for another drug. These vouchers are considered a strong incentive for drug companies to develop products. Senator Harkin, who also chairs the appropriations subcommittee that oversees most of HHS, has been one of the most vocal proponents of additional funding to fight Ebola. This might occur as part of a supplemental appropriations bill or as part of whatever happens with the current CR that ends December 11. An Administration request is expected that will help legislators clarify how much is needed.

• FasterCures Pens Huffington Post Article Highlighting the Importance of FDA Funding to Advancing Medical Research. Margaret Anderson, Executive Director of FasterCures and an Alliance Board member, wrote an opinion piece for the Huffington Post this week about the changes underway in medical research. As part of her opinion, she writes about the importance of sustainable and predictable funding for the FDA. You can read Margaret’s article here.

• FDA’s Food Safety Challenge Explained. In an earlier Analysis and Commentary, we talked about FDA's new X-prize competition for development of new tools to combat salmonella contamination and consequent foodborne illness. The background to this effort -- as well as description of some new innovative tools coming on board soon -- are described in an interview with a senior science advisor in FDA’s Office of Food and Veterinary Medicine.

• Global Harmonization at Work. FDA has announced expansion of the scope of the Medical Device Single Audit Program (MDSAP). The goal of MDSAP is to allow manufactures to undergo one audit by an accredited third party to satisfy quality regulations for the US, Canada, Brazil, and Australia.  Under the new policy, warning letters will not be issued to manufacturers that volunteer to be inspected under this program unless a significant threat to public health is uncovered.

• Post-Election Briefing on November 11. The Alliance will have a post-election briefing on November 11 at 11 a.m. Some of Ladd’s political colleagues at Akin, Gump will provide their analysis of the election results and implications for Congress in 2015 and for the Presidential race in 2016. To attend, please e-mail your RSVP 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.