From time to time, I field questions centered around FDA press releases and what they say. Every time I would have to go hunt and peck through years of releases to get an answer. Eventually I just put them into a data base so that I could track them categorically and end the scavenger hunt. In February of this year after completing it, I posted a review of the previous year’s releases and what they said and there was a good deal of interest in it – so here is an update looking at the first six months of 2014 – which I can scarcely believe are already over.
What does the agency that oversees the regulation of one-quarter of the U.S. economy have to say for itself? Here is an overview by subject matter:
To put that in context, the chart below compares the first six months of 2013 with the first six months of 2014. A few bullet points of observations:
- There were slightly fewer releases in the first half of 2014 compared to last year;
- There was a significant drop in the numbers of releases related to drugs and an increase in those referring to devices;
- There were slightly fewer announcements regarding approvals – 44 in 2013 compared to 40 in 2014, but perhaps more interesting was the fact that last year nearly 80% of approval announcement involved drugs while this year that dropped to 63%. Correspondingly, last year by this time there were 8 device approvals announced – a number which has nearly doubled to 15 for this year.
- There have been slightly fewer public health alerts and far fewer recalls, but there has been a slight increase in the numbers of new rules and guidances that were announced.
Here it is strictly by the numbers:
Happy Independence Day for America. This week also so Canada Day. So while a week where work productivity may have dipped, enjoyment factors probably drove up – at least in North America. The season is marked by hot, humid days and stormy nights, especially now as Hurricane Arthur takes an excursion along the Southeast coast in the Atlantic. So many things going on.
And here are few from this week that caught my eye related to FDA, pharma and communications:
- Accelerated Approval for a New Drug – Always noteworthy, FDA announced this week the accelerated approval of Beleodaq – a new treatment with orphan status for a type of Non-Hodgkin Lymphoma called peripheral T-Cell lymphoma (PTCL) – one of the ways in which lymph nodes can become cancerous – from Spectrum Pharmaceuticals. The drug works by stopping an enzyme that contributes to T-Cells becoming cancerous and is the third drug approved since 2009 for PTCL, according to FDA and FDA took the unusual step of listing those in this press release. Accelerated approval, it should be noted, allows approval based upon surrogate endpoints which would be reasonably likely to produce a clinical benefit. Accelerated approval is one of four designations that can alter the approval pathway timing and course and differs from Fast Track. Here is an FDA Web page that provides an overview of them. And here is the Guidance on Expedited Programs for Serious Conditions.
- More Information on Regulation of Compounders – In 2012 and throughout 2013, in response to highly publicized adverse events associated with compounded products, policy actions were taken to increase FDA’s authority over that sector resulting in a series of new steps to help define the environment regarding compounding. Eye on FDA has a tab for compiling a historical timeline of many of these actions. This week, FDA announced a series of steps to move the process along, including (1) a draft interim guidance on maintaining current Good Manufacturing Practices (cGMP); (2) a new proposed rule that would revise the list of drugs that may not be compounded; (3) a Final Guidance on the practice of compounding and regulatory actions related thereto; two Federal Register notices – one a list of bulk drugs that may be used in compounding according to one section of the regulations and another for a second section.
- Legal Actions – FDA announced two legal actions that provide insight into different regulatory oversight – the first was against a California company in which the agency was seeking a permanent injunction because FDA said was selling products that were actually over-the-counter (OTC) drug products without approval. The second action related to a dietary supplement manufacturer where the agency obtained a consent decree due after the agency issued warnings about a product being sold that contained ingredients in the form of controlled substances that were not included in the ingredient label.
Time to fire up the grill! Happy Independence Day to U.S. readers; Happy Canada Day to Canadian readers and the rest of you – have a wonderful weekend.
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”.