Weekly Roundup – 10.24.14

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.

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Healthcare and the Election – Stateside Ballot Initiatives

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.

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Weekly Roundup – 10.17.14

Missed last week and sorry about that and this week’s roundup is a day late.  It has been a busy Fall and even yesterday was a travel day.  I can barely keep up with how quickly the year is passing.

And in health care, there has been a great deal of news, some of it not very good.  Let’s try to focus today on a few of the more positive developments from our friends at FDA.

  • Two Approvals for Idiopathic Pulmonary Fibrosis – On the same day, FDA announced the approval of two new treatments for Idiopathic Pulmonary Fibrosis, a condition that causes gradual scarring of the lungs and can result in the need for transplant.  Both products had fast track, priority review, breakthrough and orphan product designations.  (You can see the differences between the first three of those here.)  The first announcement from FDA was about Esbriet (perfenidone) and the second was for a drug named Ofev (nintedanib) is a kinase inhibitor.
  • FDA Approves Labeling for XR Abuse Deterrent Opioid – An extended release opioid analgesic – Embeda – got the ok for approved new labeling this week and is the third such product approved under the FDA’s 2013 draft guidance “Abuse Deterrent Opioids – Evaluation and Labeling.”  The label reflects that fact that the product has properties that are expected to reduce the possibility of oral abuse when crushed, though there are not properties that would prevent abuse altogether.
  • Legislation Introduced on Prescription Drug and Heroin Addiction - On a related note, Senator Edward Markey of Massachusetts announced that he was releasing a report this week to address addiction issues related to both prescription drug products and heroin.  The report contains policy recommendations that address a number of issues associated with addiction and abuse under three primary categories including in part:  Prevention – increasing awareness, research on tamper-proof design, tracking prescriptions, proper disposal; Enforcement –  strengthening courts, improving treatment in prisons and ensuring medical coverage upon re-entry after discharge;  and Treatment – improving access to dependence treatment and evidence based treatments, increasing capacity, reducing insurance barriers, and improving care.

That’s it for me this week.  Have a good weekend everyone.

Photo Credit:  Anne Becker

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AdComms for Last Quarter of 2014

It is hard to believe it, but we have entered the final quarter of 2014.  I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided an overview by subject matter – as opposed to the chronological listing on the FDA site – seemed to have been useful for a number of readers. To see the full information provided by FDA, visit the FDA calendar page.

CARDIOVASCULAR

CANCER

  • NDA – Mulitple Myeloma – A candidate treatment for multiple myeloma will be considered by the Oncology Drugs Advisory Committee on November 6.  The session is slated for the morning session and the proposed indication is for use in patients who have received at least 1 prior therapy and to be used  in combination with bortezomib and dexamethasone.
  • NDA – CKD - The NDA for ferric pyrophosphate solution for the treatment of iron loss or deficiancy in adult patients with hemodialysis-dependent stage 5 chronic kidney disesse an to reduce the prescribed dose of erythropoiesis stimulating agent required to maintain hemoglobin levels.

CYSTIC FIBROSIS

  • sNDA Consideration for ivacaftor Oral Tablets – On October 21, the Pulmonary-Allergy AdComm will meet to consider the sNDA for ivacaftor for the treatment of cystic fibrosis in patients 6 years and older with a R117H mutation in the cycstic fibrosis transmembrane conductance regulator gene.

GUIDANCE

  • Study Design – Oncoloytic Products – The Cellular, Tissue and Gene Therapies AdComm will be meeting on November 6 to discuss a draft guidance for industry – “Design and Analysis of Shedding Studies for Virus or Bacteria- Based Gene Therapy and Oncolytic Products” and the Dear Gene Therapy IND or Master File Sponsor Letter.

OPHTHALMOLOGY

  • Lens Consideration – The Ophthalmic Devices AdComm will meet on November 14 to discuss the premarket approval for an intraocular lens that combines the optical properties of a +3 diopter multifocal lens with the optical properties of a toric intraocular lens.  The proposed indication is for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a catactous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence.

PAIN

  • Device Consideration – On December 12, the Orthopaedic and Rehabilitation Devices AdComm will meet to discuss the premarket approval application for a device with the proposed indication to treat skelatally mature patients sufering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, withoor without Grade 1 spondylolisthesis, confirmed by X-Ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing.

PSORIASIS

  • BLA for secukinumab – The Dermatologic and Ophthalmic Drugs AdComm will meet on October 20  to consider the BLA for a monoclonal antibody fo rthe treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

SAFETY

  • Adverse Event Discussion – Chantix - On October 16, there will be a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee to discuss the safety data from observational studies and a meta-analysis of clinical trials since the original signal of neuropsychiatric adverse events associated with CHANTIX and whether any action needs to be taken.
  • REMS Examination – The Drug Safety and Risk Management AdComm will meet on November 18 to examine the REMS program for eculizumab (SOLIRIS) under the terms of the FDAAA which requires FDA to examine one or more REMS program at least annually to review a REMS program to ensure that it is not unduly burdensome on patient access to drugs and to minimize the burden on the health care delivery system.
  • Epidural Steroid InjectionsOn November 24, the Anesthetic and Analgesic AdComm will meet to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management and also consider the efficacy of ESI and te overall risk/benefit ratio.

Posting has been a challenge lately due to my schedule, but some good stuff coming up on social media and pharma.  Stay tuned.

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Weekly Roundup 10.3.14

Back from a brief vacay to discover that leaves are littering the yard and porch as if it were autumn and then realizing that it is, in fact, autumn.  The year is going by so quickly and there is so much to do.  And with the brief and slight chill that is present in the air, my thoughts whiz right past Halloween to beginning to percolate ideas for the Thanksgiving week menus.

For those of you with your feed more secured to the ground, here is a bit of what happened this week:

  • HHS Publishes the Sunshine Act Data – The very, very long-awaited publication of the data collected under the Sunshine Act designed to provide insight into the financial relationships between the medical products industry and key stakeholders such as physicians and teaching hospitals was published this week on the website of CMS.  To say the least, the data base known as Open Payments is a big piece of machinery and navigating it is not so intuitive or easy as one might think (or hope).  Nevertheless, it is there and ready to be explored.
  • FDA Updates Ebola Page on Website – With the escalation of news regarding the Ebola outbreak in West Africa and the subsequent first case diagnosed in the United States, there is a consequential need for more in-depth information.  This week FDA expanded upon its new Ebola section of the FDA Website that overviews a timeline of events, latest developments, FDA’s involvement, news about treatments – both investigative and fraudulent.
  • More on Cyber Security and Medical Devices – Last week it was noted in the Weekly Roundup that FDA would be holding a public hearing on cyber security and medical devices.  On the same topic, this week the agency announced availability of a guidance – “Content and PreMarket Submissions for Management of Cybersecurity in Medical Devices“.  FDA is recommending that cybersecurity be a component of the design and development of a device and also are inviting manufacturers to submit their plans for patches to be provided to improve security for software.

That’s it for me this week.  Have a good weekend everyone.

Photo Credit:  Anne Becker

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