We have just been through an election cycle and the 113th Congress is in lame duck session. We are about to move on to the new Congress in January 2015. Who did America elect and what is their position on key health care issues? Who among them are poised to be the next health care leaders in Congress?
There is the obvious political side of the implementation of the Affordable Care Act which is inevitably going to resurface, but there are also perennial issues at play as well – medical innovation, children’s health, mental health, Medicare, reproductive rights and veterans’ health. The makeup of the new member of the new Congress will be poised to perhaps sway things one way or another in the 114th.
Fortunately, colleagues at a sister agency – TogoRun – here in Washington have put together an overview of incoming members from a healthcare point of view. It is available for you to download here. The guide is informative and easy to use – assessing how the new members affect the Congress in the aggregate and also to see one individually close up assessing their health care specific background and positions. You can look at their background and their history associated with disease-specific issues as well as their professional associations in health care.
I would like to say I wrote this resource, but instead I am relegated to be an advocate for it. Check it out.
It is a lovely autumn in our nation’s capital – at least looking at the trees and the light. It is always remarkable how the light angles change and the sun will suddenly appear beneath clouds instead of over them to give us colorful beautiful sunsets. And in this busy, busy time of year, it is good to have a steady supply of lovely colors to remind us of how good it feels just to experience the moment rather than be caught up in the future or the past.
But here are a few moments from this past week for you to ponder in case you are challenged to stay in the moment:
- OPDP Issues Untitled Letter - In what has been a record-low year for Warning and Untitled Letters out of FDA’s Office of Prescription Drug Promotion (OPDP), a letter was posted this week – only the 9th of the year. The letter involved a sales aid where the agency found that while some risk information was included, all of the contraindications were omitted as well as other important risk information and reminded us that further risk information cannot be incorporated by reference. The agency also found the way in which the product was positioned for its uniqueness also suggested that the product was safer and more effective.
- Ups and Downs of ODAC – In a vote of 8-3, members of the Oncologic Drugs Advisory Committee recommended that FDA approve Triferic for the treatment of iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease. The vote of the committee is a recommendation which FDA may or may not follow. The PDUFA date for deciding on approval is January 24, 2015. On another note, the same panel voted down a proposed treatment – a pan-deacetylase (pan-DAC) inhibitor – for multiple myeloma 5-2.
FDA has been very quiet of late. No press releases this month. No speeches. No testimonies. And so that’s it for me this week. Have a good weekend everyone.
Autumn is well upon us. Nature is showing us how diverse her color palette really is and it is always important to take some time and stop and enjoy it — sometimes hard to do when the demands of world and work bear down — but important nonetheless. Soon we will be confined to the more limited hues of blues and grays.
- Ebola Vaccine Development Fast Tracked – On both sides of the pond, there appears every attempt to speed up development of an Ebola vaccine. This week NIH announced that it is beginning an early human clinical trial of a vaccine candidate – the second. The candidate vaccine is called VSV-ZEBOV will be assessed for safety and its ability to generate an immune system response in healthy adults given two intramuscular doses and will be tested as a single dose. Another vaccine candidate has testing underway with initial data results expected by the end of 2014. In a related note, the EMA issued a statement encouraging developers of Ebola vaccines to apply for orphan designation.
- FDA Commissioner Hamburg Talks on Orphan Products and Rare Diseases – Speaking of rare diseases, FDA Commissioner Hamburg spoke this week a the NORD Rare Diseases and Orphan Products Breakthrough Summit in Alexandria, Virginia – one of many FDA officials present at the meeting. The title of her talk was “A Pivotal Moment for the Treatment of Rare Diseases” and she used part of her talk to underscore the need for product development respecting Ebola and stated that the agency will do all it can to facilitate access to investigational products, responding “as flexibly as we can”. Among other things, she underscored the need understand the impact of rare diseases and that while rare, there are enough of them to impact large numbers of people.
- Blood Products AdComm Set for Early December on Multiple Issues – The Blood Products Advisory Committee has slated December 2 and 3 for a meeting that will consider several issues. Among them is a session where the panel will hear scientific data related to the long-standing gay male blood donor deferral policy. Currently FDA’s policy is that men who have had sex with other men at any time since 1977 are currently deferred as blood donors. The Committee will also be hearing an informational presentation on the first survey of the Rapid Donor Surveillance Project on MERS.
That’s it for me this week. Go out and look at all the colors. And have a good one.