Well, I am late again with the Weekly Roundup and I once again seek forgiveness. I didn’t even get much time to tweet! It has been a rowdy few weeks and the summer is shaping up to be unruly. We began summer in earnest this week and are already sitting on the cusp of the July 4 holiday. Everything in the garden is growing like weeds, especially the weeds. The grass I never planted sits in a bag in the shed, waiting now for the fall planting. It is just that kind of summer.
Hopefully you have a few moments however to kick back and look at a few of the things that happened this week:
- Diabetes Drug Afrezza Gets FDA Approval – The top approval news this week belongs to Mannkind’s Afrezza, a form of insulin to treat Type 1 and Type 2 diabetes that is administered through inhalation. The inhalation powder is a fast-acting insulin that is inhaled at the beginning of each meal, or within 20 minutes after starting a meal. The approval has been long-sought and is an example of a company coming back after receiving a Complete Response Letter from FDA, not once but twice – in March 2010 and again in January 2011. The agency announced the approval on Friday, stating that Afrezza would have a Boxed Warning regarding the potential for acute bronchospasm in patients with COPD and a REMS program regarding informing physicians of same. In addition, there are post-marketing studies slated for the drug. You can view the company press release here.
- New Device Approval for People with Spinal Injury – FDA also announced approval of the first motorized device that is intended to act as an exoskeleton to be used by people who have lower body paralysis due to a spinal cord injury. Named “ReWalk” – the device is worn over the legs and extends to part of the upper body. The agency said in its release that ReWalk is for people with paraplegia due to spinal injuries at specific sites. In order to use the device, patients and their caregivers will have to undergo training in a program designed by the manufacturer – Argo Medical Technologies which will also be conducting a post-marketing clinical study that will consist of a registry to collect data on adverse events related to the use of the device and to assess the training program. A film news report is available here.
Time to go enjoy the summer weekend. Have a good one everyone!
Remember when your phone was just a phone? You flipped it open and made a call. It also may have told you the time, but you primarily used it for talking to people. Today you actually use it in ways so that you don’t have to talk to people.
Instead, you can use your phone to text, IM or send an email, but you don’t have to make a call. You can check the weather, news, sports. You can play music – even watch a movie. You can use it as a compass or to provide you with a map and directions. It can be a fitness partner to track your progress – a dietary guide and oh – did you know that you can take pictures of yourself and post them to Facebook? And you can even do things like take your blood pressure, look at X-Rays and there are numerous diabetes apps. (If you are interested in more along the lines of medical apps, here is a dandy resource.) In fact, your phone has evolved to the point where it is highly likely that one of the things you use it for the least is to have it be a phone. It is now more a personal assistant.
Your watch has pretty much always been there to tell you the time (though now your phone does that). Yesterday was the “pre-launch” of a new “smartwatch” in an ever expanding line to make news. The watch comes with a built in heart monitor and will pair with other devices and will be a tool in managing fitness, among other things.
At some point, one simply has to assume that the smartwatch, along with the smartphone, will be able to help drugs that are sitting behind the prescription pad to make their way to the OTC counter. For many drugs, such as statins, the inability to monitor one’s own liver functions and cholesterol levels has meant that attempt to switch statins from RX to OTC have failed. (I attended most, if not all of the AdComms.) But as our technology advances and becomes more accessible, and our watches and phones stop telling us the time and making our calls in favor of providing us with ever expanding amounts of information about ourselves, at some point it is likely that the watch and the phone will help us do things that we can only do with our doctors now – and hence opening up a bit the vault of drugs that can be switched from RX to OTC. Just “watch”.
I don’t usually do adverts here on the blog – in fact never, but you may remember a posting I did a few months back on the communications implications of the Sunshine Act implementation. There is room to be expansive upon the topic beyond a blog posting and so that end, I will be giving a Webinar on the topic this Thursday, June 19 at 12 noon Eastern.
At the end of September, the government is scheduled to publish financial data it has been gathering to create greater transparency on the financial relationship between industry and prescribers. Manufacturers, teaching hospitals, physicians and medical societies are all stakeholders. What kind of stories can be expected as a result and what should be done now to prepare? I’ll be sharing some thoughts on the matter.
The Webinar is free and if you would like to join us, here is the link.
It is hot. It is humid. Mosquitoes have begun to make their presence known. Thunder and rain showers occur almost daily. Summer is truly here. And we are making our way rapidly to my favorite day of the year – the day with the longest daylight is just over a week away. Seems like only yesterday I was lamenting about the lack of daylight.
The summer seems off to a slow start, but here are a few things of note from the week:
- Cheese – Yes cheese. It was a main topic for the week. There was a groundswell of reaction to reports that FDA was moving to disallow artisan cheese makers to use wood shelving when aging their product. Certainly my Facebook page lit up on both sides of the Atlantic with comments that included a good deal of scorn related to this news. The reaction reached such a pitch that the agency responded by posting a clarification on its Website stating the following: ”To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisnal cheese….The communication was not intended as an official policy statement, but was provided as background information…” Thank goodness, the matter is apparently laid to rest.
- Fish. Yes, it is all about food this week. While the cheese issue was being resolved, FDA and the EPA joined together to issue notice that they have concluded that pregnant women, those women who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain developmental and health benefits. While the agencies had previously cited a maximum amount, they had not cited a minimum amount of fish to consume. The notice came after an analysis of consumption data showed that out of 1,000 pregnant women, 21 percent had eaten no fish the previous month and those who did were eating small amounts. The updated advice recommends 8-12 ounces per week. Lower mercury choices were listed as shrimp, pollock, salmon, cannled light tuna, tilapia, catfish and cod.
- OPDP Issues Only 4th Untitled Letter for the Year – For those of us watching the edicts of the Office of Prescription Drug Promotion closely, we are left wondering what is going on at that office. OPDP in 2014 has proceeded with enforcement at a record slow pace, issuing only the 4th letter of the year this week. Normally by this time of the year they would have issued at least twice that many, judging by the past few years. It is noteworthy because guidances and these letters are two of the only insights that the outside world has into understanding policy from FDA – and there has not been much of either.
That’s it for me this week. Have a good weekend everyone.