As we all emerge from the first full work-week of the new year, there is among many a sa strong shared sense that the last 5 days have actually been more like 5 weeks. And even though it seemed like a long week, as weather stepped in to stifle human activity with fierce snows, biting winds and many, many cancelled flights, it also may seem like not much happened. Nevertheless, as we ponder our progress on those New Year’s resolutions, here are a few things did happen and here are a few from our corner of the world:
- FDA Approves New Type 2 Diabetes Drug – The first announced approval this year by FDA was Farxiga, a product jointly marketed by Bristol Myers Squibb and AstraZeneca. The drug is a sodium-glucose co-transporter 2 (SGLT2) that blocks reabsorption of glucose by the kidney, increases glucose excretion and lowers blood glucose levels. The press release from FDA stated that a whopping six different post-marketing reuirements have been slated for the drug: a cardiovascular outcomes study; a bladder cancer risk study; a study on reduced urine flow; two pharmacokinetic studies for pediatric patients; and a pharmacovigilance program to monitor for specific adverse events.
- First Gel Approved for Sealing Corneal Incision – FDA announced the approval of the first gel approved for sealing corneal incisions made after cataract surgery. Apparently prior to this, stitches were the only option for closing a leaking corneal incision after cataract surgery.
- Lots of FDA AdComm Scheduling – Though the tentative calendar for FDA AdComm meetings is up, it is still highly incomplete. Nevertheless, there were several AdComms scheduled this week: (1) a meeting of the Cardiovascular AdComm to consider approval for an NDA for a product that would reduce thrombotic cardiovascular events in patients with coronary artery disease undergoing PCI; (2) NDAC and the Pulmonary AdComms will meet to consider a replacement for Primatene Mist inhalers; (3) the Cardiovascular AdComm will meet to consider a BLA for a product to improve symptoms of acute heart failure; (4) the Arthritis and Risk Safety AdComms will meet to consider NSAIDS and cardiovascular risk labeling issues; and (5) there will be an Anesthesiology and Respiratory AdComm to consider approval for a sleep apnea device.
- FDA Brings Back Defunct AdComm -Apparently for legal reasons you can read here, in 2002 FDA terminated the function of its Pharmacy Compounding Advisory Committee. In the wake of receiving its new legal authorities to more closely regulate pharmacy compounding following the passage into law of the Drug Quality and Security Act of 2013, the committee is being re-established and the agency is taking nominations for members in the form of a voting consumer representative and for a non-voting industry representative.
That’s all for this extraordinarily long week. Have a good weekend everyone.
I usually wait a little bit longer after the end of the quarter to write up a summary of letters issued by the Office of Prescription Drug Promotion (OPDP) because there can sometimes be a healthy lag time between the issuance of a letter and the posting of a letter on the site, but here goes.
For starters, this quarter comes on the heels of a quarter notable for its utter lack of enforcement activity. The third quarter of 2013 – July, August and September, OPDP had only 3 letters issued during July and none for the entire August – September time period (note – the government shutdown was only October 1-16). During the 4th quarter, OPDP seemed to try to make up for lost time and issued a total of 10 letters during the quarter, but that still resulted in the fewest number of letters issued since 2008 and only about half the number issued during 2010.
The 10 letters issued this quarter cited 27 different violations with the category garnering the most violations being the minimization or omission of risk information – as is the usual case. There were
- 4 violations of Superiority Claims and
- 3 of Unsubstantiated Claims with
- 2 broadening of indication and only
- 1 overstatement of efficacy
- the balance in a catchall “other” category are less common violations
Warning versus NOV – Interestingly, of the 10 letters issued this quarter, only one was a Warning Letter and the balance were NOV or Untitled Letters.
Digital versus Traditional Properties - Also of note, of the communications vehicles involved which carried the material OPDP found in violation, only 2 were digital properties (both Webpages) and the balance were non-digital forms of communication including
- one brochure
- one direct mail piece
- three letters or direct mail pieces
- one sales aid
- one invitation, and
- oral statements made by a company representative (the CEO)
Numbers aside, there were some valuable lessons learned from this quarter. One is that when it comes to oral statements – it is very important that a speaker be prepped to understand the parameters of what may be permissible in characterizing the impact of a medical intervention. See Warning Letters and the Spoken Word from Eye on FDA, November 25, 2013. Other lessons will be covered in the upcoming annual look back at letters where the entire year will be profiled.
What? A Weekly Roundup after such a short quiet week? And a week when there was a snow storm to boot? Even these sheepdogs can’t find the sheep to round up! Well it may have seemed like a quiet, uneventful week, but a few things of note did happen, so why not round them up?
- FDA Issues Consumer Update on Supplements and Concussions – On New Year’s Eve FDA issued a Consumer Update entitled “Can a Dietary Supplement Treat a Concussion? No.” The agency was concerned that makers of some supplements were making claims that their products could aid in recovery from traumatic brain injuries (TBIs) when, as FDA pointed out, there is growing evidence that resumption of strenuous activity too soon after an injury can have a greater chance of risking a subsequent concussion. It is apparently not the first time the issue has come up, with FDA having issued letters around similar circumstances in 2012, but the agency did issue a warning letter related to the latest claims.
- FDA Posts Tentative AdComm Calendar – Sort of - Near the end of every year, FDA posts a listing of tentative dates for the coming year for all of the advisory committees that provide the agency with input into product approval and policy decisions. Getting that insight into the schedule gives one an idea of what therapeutic categories are likely going to have issues or products to discuss – so that if the Oncology Drugs Advisory Committee (ODAC), for example, has several dates set, it signals the possibility of a number of products coming from the pipeline. But the AdComm tentative dates schedule for 2014 did not come out by year’s end and only got published this week. Even so, one can see that only some of the committees have tentative meetings scheduled and even then, it is usually only for one date. Hopefully the schedule will fill out as time goes by.
- Risk Communications AdComm – And speaking of Consumer Updates, FDA announced this week a meeting of the Risk Communications Advisory Committee for February 3 and 4 to discuss how FDA can evaluate whether its “Consumer Updates” are reaching the targeted population and whether they are increasing awareness and understanding of the key risk messages. The agency says that the discussion will assess whether the communications are having the intended impact on knowledge, behaviors and outcomes. I hope to be able to attend this meeting and will report out on it.
See? Stuff did happen this week. If you are in part of the country that got walloped by the snowstorm, I hope you are safe and warm with comfort food close at hand. Wherever you are, have a wonderful weekend.
Happy New Year! It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. Here is a little overview of events that shaped the FDA landscape this year:
- Legislation and FDA Authority - Occasionally FDA gets new regulatory authorities as a result of legislation passed by Congress. Despite the fact that this Congress has not produced as much legislation as others have, the Congress did pass and the President did sign legislation – the Drug Quality and Security Act – that gives the agency new authorities in regulating compounding pharmacies. The action came after several high-profile recalls during the course of the year that resulted in Congressional hearings, FDA testimony and consequential legislation. An overview of the compounding issue events can be found at the blog web site tab on Compounding.
- Guidances – Related to the passage of the above mentioned legislation, FDA developed pharmacy compounding draft guidances in record time, indicating that FDA was not only eager for the compounding authority, but was quite ready to accept the authority once given by the legislation. By my count, I saw 29 guidance documents issued last year – 3 of which were about pharmacy compounding: (1) Interim Product Reporting for Human Drug Compounding Outsourcing Facilities; (2) Registration for Human Drug Compounding Outsourcing Facilities, and (3) Pharmacy Compounding of Human Drug Products. In addition to these draft guidances on compounding, an additional draft guidance of interest to those in communications would be Product Name Placement, Size and Prominence in Advertising.
- Drug Approvals - While last year, there were a whopping 39 approvals last year, there were only 27 new molecular entities approved this year. That said, there were some important approvals among those 27, including new treatments for Hepatitis C and one new treatment in prostate cancer. Aside from new molecular entities, also of note this year was the approval for OTC status of the contraceptive pill Plan B - often called the “morning after pill” which had the rockiest road to OTC status of perhaps any drug – among other things first being approved for women 15 years and older and later for all women of child-bearing age.
- Device Approvals – There were over 30 device approvals during 2013 – one of which was approved to reduce the frequency of epileptic seizures in patients who have not responded well to medications and another of interest which was the first device approved for use in the treatment of migraine pain relief.
- Social Media – Of course, the one thing that didn’t happen in 2013 was the same thing that did not happen in any year since 2009 when FDA held a public meeting about the regulation of product promotion via the Internet or through social media. Long termed a priority, the development of a guidance resulting from this meeting is still to come. Word on the street is to look for the draft to come out before or during July 2014 when there is a legislative requirement. Note, however, it is not unprecedented for the executive branch to let legislative requirement deadlines come and go. (Meanwhile FDA is now running 13 different twitter feeds – a new one which was added this year – the @FDA McMi feed, a Facebook page, Flickr and a YouTube channel. You can view all FDA tweets from the Eye on FDA listing of all FDA Tweets.)
As for Warning and Untitled letters, that will be the subject of a separate posting. The posting of these letters on the FDA site sometimes has a lag time and so that analysis will come a little further into the new year.
Again best wishes for the new year.
Yes, I did it. Cards addressed and sent. Gifts purchased, wrapped and sent. The snow in my snow globe descends quietly and peacefully conveying my own inner serenity….
And here is a little of what happened this week, as 2013 begins to pack its bags:
- New Food Defense Rule Proposed – FDA is seeking public comment on a proposed rule aimed at bolstering security around the food supply by proposing preventive strategies be put into place through a planning effort by large food facilities. Under the rule, large facilities would have to examine their operation for possible vulnerabilities and then execute planning to address them. The Federal Register notice regarding the proposed rule and process for comment can be found here.
- New Stent Cleared for Marketing to Treat Pseudocysts of the Pancreas – FDA announced this week the clearance for marketing of a new stent that would treat pseudocysts of the pancreas. The agency said this is the first stent that is specifically designed for this purpose by creating a new and temporary opening from the pancreas to the gastrointestinal tract to treat the condition and provides physicians a new option that offers a less invasive method to treat than surgery to remove the pseudocyst.
- New COPD Treatment Approved – GSK’s Anoro Ellipta got the approval nod from FDA this week. It is a combination, long-term treatment that is inhaled. The product label will include a boxed warning and is not indicated for use in patents with asthma.
- Soap on a Rope - This week the agency put the spotlight on antibacterial soaps by issuing a proposed rule that would require manufacturers of such soaps to prove that their long term use is safe and that the efficacy of such products exceeds use of plain soap and water and products not being able to do so will be re-formulated and relabeled. This does not affect hand sanitzers or sanitized wipes. The proposed rule will be available for comment for 180 days.
That’s it for me this week. For those celebrating a holiday next week, my very best wishes.