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– Embeda – got the ok for approved new labeling this week and is the third such product approved under the FDA’s 2013 draft guidance “Abuse Deterrent Opioids – Evaluation and Labeling.”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
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.
- NDA Consideration Stroke Treatment - On October 30, the Cardiovascular and Renal AdComm will meet to consider an NDA for edoxaban tablets being assessed for the prevention of storke and systemic embolism in patients with nonvavular atrial fibrillation.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 Injections – On 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.
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
I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days.
And here is what happened this week in reality-based Washington, D.C.
- Ebola Candidate Treatment Emergency Use - Reuters reported this week that FDA was allowing the emergency use of Tekmira’s investigative compound TKM-Ebola being studied as a treatment for Ebola. Canada also issued a similar authorization. And the company announced this week that it would be joining an international consortium to conduct clinical trials for new treatments in West Africa.
- FDA Warns Purveyors of Ebola Treatments – On a related but entirely different note, FDA issued warning letters to 3 companies that the agency said were marketing preventions and/or cures for Ebola. The letters were issued on September 22 and 23 and represented a range of types of products. FDA has put up a web page on Ebola and overviews distinctions between investigative compounds and fraudulent products.
- CyberSecurity and Medical Devices – FDA announced a public workshop for October 21 and 22 to be held in Arlington, Virginia entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity” and the purpose of the meeting is to identify barriers to promoting cooperation and to consider strategies to overcome various challenges.
- Social Media Guidance Comment Period Extended - FDA announced that it would be extending the time period for comment from the public regarding the two social media guidances issued in June. The agency took five years to produce the guidances and is seeing fit to give the public a bit more time to provide input. According to the notice sent by FDA, the time period will be extended from September 29 to October 29.
That’s it for me. Back to vacation. Have a good weekend everyone.