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.
We are days away from the mid-term elections. Don’t worry, this isn’t another piece to read about how the Senate could hang in the balance for weeks; or how one party or another might retain or take control of any chamber of the Congress.
This is about what there is on the ballot in the states regarding healthcare. The National Conference of State Legislatures has a wealth of information on its website regarding what is going on at the state level. You can take a look at what states are doing with respect to various aspects of the Affordable Care Act. It is a lot so you can look at that information by topic as well.
Among the many resources and reports is a data base that contains all of the state ballot initiatives that are proposed. You can sort this data base in several ways, including topic. A look at healthcare yields 11 initiatives. Some are related to bond issues to raise funds, but here are a few of the more interesting ones:
- Use of Investigational Drugs – Arizona’s Proposition 303 would allow a manufacturer of a drug, biologic or device product to make it available to a terminally ill patient based solely on the recommendation of a physician and classifies any attempt by a state official or agent to block access thereto as a class 1 misdemeanor.
- Drug and Alcohol Testing of Physicians – Proposition 46 is on the ballot in California and requires drug and alcohol testing of doctors and reporting of a positive test to the California Medical Board. It requires the board to suspend such a physician pending investigation of a positive test and take disciplinary action if the doctor was impaired while on duty. Requires health care practitioners to report any doctor suspected of drug or alcohol impairment, among other things.
- Birth Control – Illinois is posing the question to voters – Shall any health insurance plan in Illinois that provides prescription drug coverage be required to include prescription birth control as part of that coverage?”
- Pharmacy Ownership - North Dakota is asking voters if the requirement that a pharmacy be owned by a licensed pharmacist should be removed.
- Inclusion of Providers on Insurer Provider List - South Dakota has a measure on the ballot that would require all insurers to list all providers who are willing and who meet the conditions for participation that have been established by an insurer to be on the insurers list of providers.
One can sort on other areas besides healthcare to get a good view of what is going on at a state level with regard to a whole host of topics. Check it out.