Weekly Roundup 1.15.16

In the mid-Atlantic, it has been a winter without snow. In fact, despite a few genuinely chilly days, it has largely been balmy. I know some people don’t miss it – in fact perhaps most. But I always think there is a spirit-calming benefit to a vast, deep, downy snow that brings traffic – both pedestrian and vehicular – to a halt while we are relegated to sitting inside, making comfort foods and being shaken from our busy routine. Nothing on the horizon for the rest of January, so we can only wait to see what February will bring.

And while we wait, here is a bit of interest from the week:

  • Califf Gets Support from Senate PanelDr. Robert Califf, currently the Deputy Commissioner for Medical Products and Tobacco at FDA and tapped by President Obama as the next Commissioner for the agency received the unanimous support from the Senate HELP Committee this week in a voice vote. However, it was reported in Stat this week as well that the nomination faces some opposition from one Senator over the issue of labeling for genetically modified food – particularly salmon. You can check out the story here.
  • FDA AdComm Recos Approval for Opioid Addiction Treatment – The Psychopharmacologic Drugs Advisory Committee voted 12 to 5 to recommend FDA approve Probuphine as the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction. The treatment must be surgically inserted and removed, treating dependence for up to six months. According to one of the sponsoring companies, this submission was made and accepted by FDA in August 2015 and the action date is February 27, 2016.
  • Developments in Duchenne – This week FDA issued a complete response letter to the company sponsoring an investigational compound, drisapersen, to treat Duchenne Muscular Dystrophy following concerns raised issues during an advisory committee meeting held last year. According to the company release, FDA had outstanding concerns that substantial evidence of efficacy had not yet been met. The company said that extension studies would continue and that patients currently receiving it would continue on drug. While currently there is no FDA approved treatment for this life-threatening genetic disorder, FDA will be considering another candidate at an advisory committee meeting to be held this month. You can read up on the condition, which affects male children, here.

That’s it for me this week folks. It is a long holiday weekend and I hope you all have a pleasant one.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | 1 Comment

FDA Press Release 2015 – What They Said

Last year and the year before, Eye on FDA provided an overview of press releases from the agency for the year that had just passed. The information comes from a database of press releases that I started back in 2013 tracking information on what was said in various categories and the purposes for which releases were posted. It is time to look back at what FDA had to say in 2015 and get a little insight into how it might differ from previous years.

A few observations of note:

  • With 173 releases this year, the total number of press releases increased this year slightly and was more than either 2013 (165) or 2014 (161);
  • You may have read that FDA approved a record number of drugs this year logging in at 45 new approvals. Counting all approval announcements – which includes drugs, devices and apps, as well as approvals for new indications – there were more approval-related announcements in 2015 (104) than there were in either of the previous two years (90 in 2014 and 81 in 2013);
  • Of the 104 approval-related announcements in 2015, 76 involved drugs, 27 involved devices and 1 was an app approval – the only category to show an increase was among drug approvals;
  • Of the 76 drug approval related announcements in 2015, one-third of them (25) involved oncology which is both a numeric and proportional increase over either 2013 or 2014.

One can see in a year by year comparison that the number of approvals is a greater percentage of the announcements. Legal actions also increased slightly in proportion during 2015 while public health alerts decreased somewhat as did rule making oriented announcements. In short, FDA attention this year appeared to be on approvals.

That’s the picture for 2015. It will be interesting of course to see what the new year brings, particularly with a new FDA Commissioner coming to the job.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in FDA Image, FDA Policy | Comments Off

Weekly Roundup 1.8.16

It is the first Weekly Roundup for 2016.  The decorations are down. The waistline is a bit increased. My resolutions seemed to be broken in record time this year. There is, of course, the back to work thing.

Though much of the country saw uncharacteristic warmth for the holidays, tempting daffodil shoots and other spring-like behaviors among both plants and animals, winter has returned. The sky has taken on that slate gray-blue cast that reminds us that while the light is weak and the days are short, as the season reminds us, it is time for the light to return and each day brings us closer.

In the meantime, here is a bit of what happened this week and it is all about devices:

  • FDA to Hold Hearing Aid Workshop, Reopens Comment Period - The agency announced this week that it was scheduling a public workshop “Streamlining Good Manufacturing Practices for Hearing Aids” for April 21 to be held at FDA headquarters as well as re-opening public comment on a draft guidance related to the agency’s premarket requirements for hearing aids. The agency acknowledged that hearing aids are under utilized. FDA appears to be seeking to learn to what extent barriers to development of devices for use by the hearing impaired play a role in that.
  • Agency Ups the Requirements on Surgical Mesh Used in Transvaginal Repair – Two final orders came out of FDA this week aimed at strengthening the data requirements on surgical mesh to repair pelvic organ prolapse transvaginally or through the vagina. One order reclassified the devices from Class II – regarded as moderate-risk devices to Class III which includes higher risk devices. The second order will require manufacturers to submit a premarket approval application with data to support safety and efficacy. The agency said it was responding to an increase seen in adverse event reporting and was following an advisory committee recommendation made five years ago that more safety data was needed.
  • First Approval Announcement of 2016 - This was for a new indication – for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. First approved in 1996 for use in burn injuries where a graft was not possible and for a new indication in 2002 when it was approved for use in patients undergoing reconstructive surgery for burns, for this indication the matrix – composed of shark cartilage, cow collagen and silicone – is placed over the diabetic ulcer to provide the basis for new skin and tissue growth. The graft cannot be used in patients with allergies to bovine collagen or cartilage.

That’s it for me this week. Next week I’ll be aiming to get out some more look-back angles at 2015, among other things. In the meantime, have a wonderful weekend.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

FDA Enforcement on Promotional Communications – 2015 Summary

Happy New Year. That means that it is that time for some of those look-back postings where we look at what FDA has and has not accomplished in the course of the year we have just been through.

In many respects it has been a banner year. Today we’ll look at the year as it relates to the work of enforcement, specifically through the Office of Prescription Drug Promotion (OPDP). And here we see that enforcement, as expressed through the issuance of Warning and Untitled letters, occurred at an all time low with the issuance of only 9 letters during 2015.

Let’s begin with a brief examination of the violations were cited involving what kinds of companies, products and communications vehicles. Second let’s consider the significance of it all.

Of the 9 letters issued this year, only 2 were Warning Letters while the remaining 7 were Untitled. Of the 9 communications vehicles involved in the violations, 4 were digital properties while the balance involved traditional media.Of the 4 digital properties, 3 of them involved websites and one of them was related to social media – an Instagram/Facebook posting that incorporated risk information by link only.

When it comes to the types of violations, the lack or minimization of risk information continues to be the most common violation, though closely rivaled this year by the citation for unsubstantiated claims.

In addition to the violations related to these letters are the recipients. As noted in an earlier related posting, for the past few years, letters largely involved companies that are lesser known and are likely to have fewer products on the market. Have large companies gotten so good at this that they do not make violations? Is there a policy reason associated with the focus on smaller companies? Are there so few violations being cited by OPDP because they have turned their attention to reviewing materials submitted by companies? Certainly, they are valid questions. Answers are not likely.

Why is any of this important? At least one reason is the unfinished work FDA – and OPDP in particular – in the area of shedding light on the rules associated with digital media. The small amount of guidance put out by FDA on the topic fails to address the breadth and depth of the questions the agency asked in 2009 when it held a two day public hearing on the Internet and social media – a meeting which set the framework for answers to outstanding questions. Not only are there many gaps, but the guidance documents that have been issued raise almost as many questions and they answered. Meanwhile digital media continues to rapidly evolve, bringing new questions into the marketplace. If the agency is silent through the guidance process and silent through the enforcement process then it leaves a large swath of unchartered and unknown territory. That, in turn, leaves a very uneven environment not just for companies, but for patients seeking health information through digital platforms.

And that is the point of view on enforcement in 2015.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Warning Letters | Comments Off

Weekly Roundup 12.18.15

It is the rush. I am caught wondering how I got here.That situation that every year I say I am going to avoid, but don’t. The one where I am rushing to get everything done before the holiday that needs to be done and feeling overly stressed. The lack of time meant a lack of posting this week, but I shall use the time over the holiday to get a little more on track. In the meantime, it was a busy week an here are a few notes of interest.

  • Future of Research – For the past few years, the future vision of government-sponsored medical research has sometimes been clouded sending advocates to the Hill to try to persuade policy makers not to cut funding. This week two items of significance provide a degree of clarity for the future. First, NIH announced that it was unveiling a 5 year strategic plan – Turning Discovery into Health. The plan outlines a very long list of aspirations that range from new levels of intensity in the battle against cancer, new wearables that will break new ground and new breakthroughs in vaccines and in HIV. And to make that all possible, with Congress poised to pass a new budget deal, funding for NIH would appear to be on track to receive the biggest boost it has gotten in over a decade.
  • Cascade of Approvals Before the Holidays – A lot of people wonder if there isn’t a big rush at the end of the year to get out approvals before the holidays. For those with that point of view, this week provided some food for thought with the announcement of three new approvals. The first was the approval of Bridion to reverse the effects of neuromuscular blocking drugs during surgery – drugs often used during intubation. The agency said that the drug could be used for faster patient recovery after a procedure but also pointed out that some patients experienced bradycardia and raised the concern of some patients experiencing anaphylaxis. News was made this week in both the diabetes and biosimilars worlds with the announcement of the first insulin approval for a follow on product in the abbreviated regulatory pathway set up for this purpose by FDA. Finally there was an approval announced for the first external defibrillator for children at risk of sudden cardiac arrest who are not candidates for an implant. Heretofore, adult devices had to be used off-label.

And for those wondering if in fact there is a year-end growth in approvals – this month has certainly seen a number of such announcements with a total so far of 9 approvals. In December of 2014, there were 17 approvals or expansions of label announced. By contrast, in 2013, there were only 7.

That’s it for me this week. Off to the post office!  Next week has Friday falling on a holiday and the same for the week after, so Eye on FDA will be on a slightly irregular publication schedule getting ready for some themes to explore in the new year. In the meantime, have a fun, safe and happy holiday season.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off