It is hard to believe that I see on Facebook many of my friends who are parents talking about their kids headed back to school this week. Back to school? Back to school? Why when I was a lad, which was really not that long ago, school never began until the day after Labor Day. I know because my birthday is the week before and it left me bitter that I never got to partake in the cupcakes in honor of my birthday that everyone else got during the school year. As you can tell, I have never gotten over that.
What I have gotten over is this past week. Here is a little bit of what happened:
- Fraudulent Ebola Products Alert - FDA issued a statement alerting consumers that they should be aware that there are products being sold online that are claiming to prevent or treat the Ebola virus. The agency reminds consumers that, while there are experimental treatments under investigation, there are no products approved for use either as a treatment or vaccine. The release refers to sources promoting the unapproved and fraudulent products but does not name them.
- New Sleep Drug Approved – The agency announced approval of a new, first-in-class drug to treat insomnia called Balsomra (suvorexant). Balsomra is an orexin receptor antagonist. The agency states that the drug alters the signaling action of orexin in the brain – with orexin being a chemical that is involfved in regulating the sleep-wake cycle. The most common side effect reported was drowsiness and the agency has asked the manufacturer to study next-day driving performance in people who take the drug. The product will be accompanied by a Medication Guide.
- FDA Approves First Non-Invasive DNA Colorectal Cancer Screening Test – Cologard was approved by FDA this week and it is the first stool-based colorectal screening test that would detect the presence of red blood cells along with DNA mutations that could be indicative of the presence of either cancers or precursors to cancers. The test requires a stool sample and will detect the presence of hemoglobin and if a positive test is received, the patient will be recommended for a diagnostic colonoscopy, offering patients a new option in their approach to screening but does not change the current practice guidelines for colorectal cancer screening.
That’s it for me this week folks. Have a good, safe and pleasant weekend. Next week we will take a look at FDA enforcement around DTC advertising. Watch for it!
August is supposed to be slow. And lazy. Laying around doing nothing. That is what Marky the Cow is doing in this picture. (For those of you who are new to Eye on FDA, Marky is a dairy cow in the state of Washington who was named for your’s truly.) Marky the Guy though has not been laying around. You may think I have disappeared, but I have just been very, very busy which means that there have been far fewer postings than usual. And in fact, last week there wasn’t even a Weekly Roundup.
But there is one this week and here it is:
- FDA Publishes Fact Sheet on Ebola – Authorizes Test Use – The watchword of the week has been Ebola with the serious outbreak in Western Africa and the return home for treatment of two American medical personnel working there. This week, on August 5, FDA published “Fact Sheet for Patients: Understanding Results from the Ebola Zaire (Target 1) Real-Time PCR (TaqMan) (EZ!rRT-PCR Test“. The Fact Sheet is actually more of a Q&A and while interesting, it was also noteworthy that in answer to the first question – what is the Ebola Zaire Test – FDA stated that it the “test has not been cleared or approved by the U.S. Food and Drug Administration..” but “FDA has authorized the emergency use of this test under an Emergency Use Authorization (EUA)”.
- CDC Puts Up Comprehensive Ebola Page – In addition, the Centers for Disease Control has put up a very comprehensive page on Ebola hemorrhagic fever on its web site covering topics such as transmission, diagnosis, signs and symptoms and treatment among other things. The page appears to be updated daily with new information. It includes fact sheets and chronologies and would appear to be an excellent resource for multiple stakeholders, including journalists.
- FDA Modifies Hold on Investigative Ebola Treatment – A company that has been researching a possible treatment for Ebola announced this week that while a full clinical hold had been placed on the clinical trial of the investigative compound TKM-Ebola, FDA had conveyed to the them that the hold would be modified to a partial hold. The Phase 1 clinical trial is looking at safety, tolerability and pharmacokinetics of administering the drug to healthy adult volunteers in single ascending doses and multiple ascending doses, though the company – Tekmira Pharmaceuticals – indicated in their release that the multi-ascending dose portion of the trial remains on hold. The story was reported in media on August 7.
That’s it for me this week. Have a good August weekend everyone.
Photo courtesy of Anne Becker.
In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often. Today is every so often. It is just a different way of viewing the very useful calendar put up by FDA. The February posting was notable because there were so few new product considerations while April saw a bump up in that regard. This time around there are NDAs, BLAs and PMAs.
- Combination Drugs – On September 10, the Cardiovascular and Renal Drugs Advisory Committee will meet to discuss the potential clinical utility of fixed-combination prescription drugs that are composed of an an anti-hypertensive with a statin and aspirin to reduce cardiovascular events and death in patients with a CV history, focusing in particular whether such a product would have a benefit and various other questions related to the possible use.
- NDA Approval Consideration – On August 14, the Pulmonary-Allergy Drugs Advisory Committeee will meet to consider an NDA submitted by Boehringer Ingleheim for tiotripium bromide inhalation sprace for the proposed indication of long-term, once-daily maintenance treatment of bronchospasms associated with COPD.
- Regulatory Classification - On July 31, the Gasteroenterology and Urology Devices Panel of the Medical Devices AdComm will meet to make recommendations regarding the classification of a number of devices considered pre-amendments devices since they were in commercial distribution prior to May 28, 1976 when the Medical Devices Amendements became effective. FDA is seeking input on the safety and effectiveness of the devices and the regulatory classification. The devices include Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electical Sperm Collection, Erectile Dysfunction Devices and Alloplastic Spermatoceles.
- BLA Approval Consideration – This week on the morning of July 31 the Blood Products Advisory Committee will meet to discuss the biologics license application of Baxter Healthcare for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune disorders. During an afternoon session, the committee will be meeting in open session to discuss reentry of blood donors who had been deferred based on Chagas disease test results.
- NDA Approval Consideration – The Dermatologic and Ophthalmic Drugs Advisory Committee will meet to consider the BLA submitted by Novartis for a monoclonal antibody that is being proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic or phototherapy.
- Adverse Event Discussion – There will be a joint meeting of the Drug Safety and Risk Management and the Psychopharmacologic Drugs Advisory Committee to discuss the risk of serious neuropsychiatric adverse events with CHANTIX tablets as well as options for addressing risk.
TESTOSTERONE REPLACEMENT THERAPY
- Safety Issues – There will be a joint meeting of the Bone, Reproductive and Urologic Drugs AdComm with the Drug Safety and Risk Management AdComm on September 17 to discuss the appropriate indicated population and potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
- NDA Approval Consideration - On the following day, September 18, there will again be a joint meeting of the two committees to consider an NDA submitted by Clarus Therapeutics for a investigative oral testosterone replacement therapy treatment.
We sit on the cusp of August – the month when America goes on vacation. Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the laziness of the season to an abrupt end.
But before that happens, let’s examine a few things from the week that might be of interest:
- Link to Webinar on FDA and Social Media – On July 17 I gave a Webinar entitled “In More Than 140 Characters: FDA’s Social Media Guidance Past, Present and Future” to which there was a large turnout, but also some folks who had signed up and could not make it. For those, and for others who may have wanted to sign up but had a conflict, here is a link to a playback of the Webinar. To those of you who came, thanks for joining me!
- FDA Approves Oxycodone with Abuse Deterrent – In a long-standing effort to create circumstances that make needed pain medication available that does not feed abuse as well, FDA this week announced approval of an oxycodone product that has abuse deterrent properties. The product is an extended release/long-acting opioid analgesic called Targiniq ER and works by including naloxone so that when the tablet is crushed in any way for use, the naloxone blocs the euphoric effects being sought. This does not preclude its abuse when taken orally. The product is indicated to treat pain that requires daily, around-the-clock, long-term opioid treatment for which alternatives are inadequate and is not indicated for as-needed pain relief. It is the second approval for extended release/long acting product approved since the agency’s 2013 draft guidance on Abuse-Deterent Opioids.
- US and Mexico Sign Statement of Intent on Produce Safety – For those who remember the 2008 Tomato scare when tons of tomatoes from Mexico were destroyed in the belief that they were connected to an outbreak of salmonella – well there was a lot of criticism to go around. This week FDA announced that FDA Commissioner Hamburg met this week with Mexican counterparts to discuss ways to strengthen cooperation in support of produce safety. The news release outlines several areas of cooperation meant to put into place preventive practices which appeared more to be aims and goals than actual policies and procedures – an observation seemingly affirmed by the posting on FDA’s blog about the two-page statement of intent between the two countries.
It is a beautiful day here in Washington, D.C. and I hope that it is for you wherever you are as well. Have a wonderful weekend.