Mark S. Senak's Blog, page 41

Weekly Roundup 1.31.14

It will be groundhog day this coming week.  I know I will be watching to see what is predicted because I, for one, am done with the cold nature of this surly winter.  Dog walks have been painful.  Cars everywhere are covered in salt.  And of course my biggest beef with winter – the days are short and there is no quality time on the front porch.  In fact, there is no time on the front porch.  I am sure many of you will be watching too.  Let’s keep our fingers crossed.

In the meantime, it was a busy week for me and I did not get any postings up, for which I am sorry.  I will endeavor next week to be more fruitful.  Meanwhile, here is a little bit of what I thought I’d pass along from this week:

First OPDP Letter of 2014 Posted – The first, and right now only, regulatory action letter from the Office of Prescription Drug Promotion was posted (technically last week, it appears, but only noticed by me this week).  It was for a sales sheet and OPDP’s letter cited several issues with the promotional language.  If you represent a product that is not intended for pregnant women, this is a letter you may want to check out to see how to avoid being dinged by the agency for broadening the patient population indicated in the label.
FDA Issues Rule to Prevent Food Safety Risks During Transportation – The seventh and final major proposed rule to be announced under the Food Safety Modernization Act (FSMA) was issued this week by FDA that would require certain shippers, receivers and carriers transporting food by motor or rail to meet specific criteria for sanitary transportation.  An example provided in the press release would be that shippers would inspect a vehicle for cleanliness prior to loading food that is not completely enclosed in a container – for example, fresh produce in vented boxes.  This rule does not cover shippers who have less than $500,000 in annual sales.  Three public meetings are scheduled around the country to discuss the proposed rule and the public comment period runs through May 31.
Preparing for Advisory Committee – In case you are interested, I will be presenting next week at the CBI conference – the 5th Annual Effective Preparation for FDA Advisory Committee Meetings on February 6 here in Washington, D.C.  I will be presenting on non-clinical aspects of preparation – so please say hi if you are there.  I will be covering panel intelligence and issues mapping as well as various aspects of pre-approval communications.

That’s it for me after this cold week.  Stay warm and be well and have a good and restful weekend.  Groundhog, do your stuff!

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Weekly Roundup – 1.24.14

Many regular readers might remember last September when I was able to share the news that a friend had named a new born calf after me – Marky! Well, Marky is growing up and here she is – pictured behind this fine young man in front – showing off her beautiful cow eyes.

It is hard to believe that January is almost over and that we are all still trying to get used to writing 2014 instead of 2013.  Actually, truth be told, I am still in the 1990s.  But as the rest of the world moves on, here is a bit of what happened this week:

FDA Issues New Guidance on Dear Healthcare Provider Letters – This week the agency announced the availability of a new guidance entitled “Dear Health Care Provider Letters: n Improving Communication of Important Safety Information” meant to provide recommendations on the content and format of these missives to convey important information about a drug or to set about correcting misinformation.  Contained in it are recommendations on when to issue a letter, the types of information in it and organization and format information. Interestingly, this is issued in the same week FDA postponed a Risk Communications Advisory Committee meeting that had been scheduled to identify the impact and reach of topics of interest to consumers that had been scheduled for February 3 and 4.
Advisory Committee Portal Launched - FDA launched a new online, interactive portal that allows for electronic submissions for persons interested in sitting on one of the agency’s 33 advisory committees.   The portal provides a paperless means of applying and applications will be uniform and streamlined.  The announcement states that nominations may be made by professional societies, industry and consumer groups and other interested persons.  Coincident with the launch of the portal, the agency also made available conflict of interest guidelines.
FDA Bars Specific Ranbaxy Facility from Producing Drugs for U.S. Market – FDA announced that it was extending the scope of an existing consent decree with Ranbaxy Laboratories to cover pharmaceutical ingredients from a Toansa, India facility which would prohibit the distribution, manufacture, exportation or provision of API to American companies following an inspection of the facility on January 11 of this year where numerous violations were said to have been found.

Yee hah – let’s get on with the weekend.  Marky (the cow) and me (Marky the person) wish you a very good one.

Photo courtesy of Anne Becker.

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Looking Back Down the Road – What Have We Learned from FDA on Regulation of Digital Media?

So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms.  It seemed like a good time to produce a recap on where we are – and where we aren’t – with respect to social media.

March 2009 – It’s the Not the Medium, It is the Message – In April 2009, representatives from the Office of Prescription Drug Promotion (OPDP), then called the Division for Drug Marketing, Advertising and Communication (DDMAC) sat down with me to do a podcast to provide their thinking into how promotional speech would be regulated on these new platforms.  At the time, the thinking seemed to be that existing regulatory guidance was sufficient – that if you couldn’t say it in print or broadcast, you couldn’t say it in social media.  In short, the attitude was – it is not the medium, it is the message.  While that sounded simple and direct, in fact, the very nature of the Internet and social media platforms raised very specific questions that were unique to digital media – which quickly became apparent the following month.
April 2009 – The 14 Untitled Letters and the One Click Rule – In a seeming contradiction to “It’s Not the Medium, It is the Message” message FDA then issued 14 untitled letters to companies primarily for a failure to include risk information in banner ads on the Internet.  Banner ads had been a widespread practice in the world of prescription product promotion because of belief in the “one-click rule” – meaning that if risk information were one click away from copy that mentioned a product name and indication, then it was permissible.  Turns out the “one-click rule” was not a rule at all.  The takeaway however was clear – FDA laid out its first “guidance” on the Internet and social media by enunciating the tenet that when you have a drug name and indication present in promotional language, the risk information cannot be anywhere else but in the same place and cannot be incorporated by reference or included by link.  The FDA action resulted in a New York Times Headline – “FDA Rules on Drug Ads Sow Confusion as Applied to Web”.
September 2009 – FDA Announces Public Meeting on Internet and Social Media – Apparently upon reflection FDA came to realize it is not just the message, it is the medium after all that begs some unique regulatory questions and announces in the Federal Register that it will hold a two-day meeting on the “Promotion of Food and Drug Association-Regulated Medical Products Using the Internet and Social Media Tools” to be held in Washington, D.C. (ironically in a room without a WiFi connection).
November 2009 – Two Day Public Workshop – FDA holds a two day meeting that had full attendance and participation by many pharmaceutical companies.  The meeting was patterned to answer a series of questions:  (1) For what online communications are manufacturers, packers, or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, post marketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and finally (5) Questions specific to Internet adverse event reporting.  The docket for this topic was open to receive comments through February 2010.
July 2010 – Agency Issues an Untitled Letter Involving Facebook – In what has been the only regulatory action involving social media as a medium, OPDP issued an untitled letter regarding a Facebook share function based in part on the fact that the share function conveyed the drug name and indication without the risk information – again another version of the “one-click” rule – not really providing any new insight into the parameters discussed at the November 2009 meeting, but reinforcing the principle that wherever goeth the name and indication also must goeth the risk information.
December 2011 – FDA Issues Draft Guidance that Mentions Social Media – After a long, long period of silence, FDA finally issued a draft guidance that mentioned social media in its context, prompting some to believe this was the long-awaited social media guidance.  Rather, it was a guidance entitled “ Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices ” which included what to do if the request came via digital media platforms, but provided little insight into FDA’s actual outlook on any of the questions raised during the 2009 public meeting.
Also in December 2012 – An Interesting Non-OPDP Warning Letter - FDA sent a Warning Letter to a manufacturer of an animal drug product that involved a social media communication. In this case, among other things that concerned FDA, the manufacturer “liked” a posting on their Facebook page that carried a claim by a third party, indicating a human had taken the product and experienced satisfactory results.  This perhaps indicates that a “like” – as an endorsement of the content that would be violative if the manufacturer had said it and one could extrapolate from this that a “re-tweet” of a comment that would contain a violative claim would also be an issue for FDA.
January 2013 – Another Non-OPDP FDA Warning Letter May Tell Us Something About Search - In the context of a letter citing other violations, one thing FDA noted in this non-OPDP Warning Letter was that by typing in specific medical conditions into the search engine on the site, the results included products which were not approved for the treatment of that condition.  ”In addition, typing the word ‘cancer’ or ‘diabetes’ into your product search field located on your website brings up your products… implying your products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.”  This at least raises some questions about optimization issues.
January 2014 – FDA Issues a Draft Guidance on Post-Marketing Submissions Involving Social Media - It is perhaps telling that FDA issued a guidance about how to do post-marketing promotional submissions involving social media without ever having issued any guidance about use of social media, but that is what happened.  Here FDA gave the most insight it has ever given on the topic.  As mentioned last week, it was perhaps most notable for what it seemed to indicate regarding third party sites and third party commentary on a company owned site.

By staging the 2009 hearing, as it did, with specific questions being asked in a specific order FDA lent the altogether reasonable impression that the agency would answer these questions in the same order the form of a guidance document. That has not happened. Instead, we are getting puzzle bits to place back into the construct of the discussion.

If you go back to the questions, one can see that these events tell us some of the answers – from use of links to how third party material is regarded.  We will hopefully see more about correcting material of third parties, more on the appropriate use of links, about optimization – something not contemplated in the hearing – and more direct guideline as to how the agency is regulating these rapidly evolving media.  After four years, we are informed, but not fully.

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Weekly Roundup 1.17.14

Two full weeks back in the saddle and I’m ready for a three day weekend.  I’m late today with the Weekly Roundup, and there isn’t a lot of news to digest, but here are a few things that came out of this week that caught my eye.

IOM Releases Report on Caffeine in Food and Supplements – Following a public workshop held in August, 2013 on the topic, the Institute of Medicine released a report today on caffeine in foods and supplements - a workshop which FDA requested.  The report embodies what is known about the regulation and science related to caffeine in foods and supplements including intake and exposure to caffeine, safety signals and surveillance, exploring exposure levels for vulnerable populations and effects on the cardiovascular and central nervous systems.  The report can be read online for free.
Test to Diagnose Developmental Disabilities – FDA announced approval of the first-of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children.  The test uses a blood sample to analyze the entire genome at one time, detecting large and small chromosomal changes.  The press release from FDA states that the test should not be used as a stand-alone diagnostic test nor should it be used in any other circumstance.

That’s it for me this week.  For those of you wondering, as I have been – Daylight Savings begins March 9.  If you can’t tell it, I am counting the days.  Here in the US it is a three-day weekend.  I hope you all enjoy it.

My thanks to Anne Becker for the photo.

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FDA Reveals More Thinking on Social Media

Don’t judge a book by its cover – or in this case, title.

In November 2009, FDA held a two-day public meeting on the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media to collect input for the eventual development of guidance.  That set off a very, very, very long wait.

In December 2011, the agency issued a draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. Because this draft guidance mentioned aspects of social media in this regard, many took it to be the long-awaited social media guidance.  Rather, it was a guidance that mentioned social media.  In fact, it appeared that FDA was providing guidance over time through a series of publications.

Yesterday, a new draft guidance was put up on the FDA site with the very complex title – Fulfilling Regulatory Requirements for Post-Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.   Reading that title, one would hardly know what it is about.  It is indeed about how to submit post-marketing submissions of promotional material for FDA review.  But importantly, it includes aspects of social media (which is what the phrase “Interactive Promotional Media” includes).

Moreover, the draft guidance gives some insight into FDA’s outlook on the regulation of social media communications on an important question raised during that 2009 public meeting so long ago.  It does so by outlining the circumstances whereby manufacturer communications are subject to review, and therefore must be in compliance. These naturally include communications that the manufacturer generates or directs to be generated through an employee or consultant.  If there is influence on the use and placement of such material in a third party site, then the site will also have to be reviewed. In other words, one is responsible for one’s own promotional communications, which is logical and unsurprising.

But perhaps the most interesting part of the draft guidance involved user generated content (UGC) that appears on an electronic site about an FDA regulated product. Any UGC developed by a manufacturer, a consultant, an employee or any other person under the manufacturer’s direction and influence, is a communication for which the manufacturer will be reviewed and for which the manufacturer is responsible.  ”However, a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular).  FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.”  (emphasis added)

So don’t let the title fool you.  With this draft, FDA appears to have clarified how it regards third party generated content with respect to electronic sites.  They did it in the context of providing companies with practical information on what must be submitted for review and how it must be done, but this insight, I think, is the real headline.

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Weekly Roundup 1-10-14

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.

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Warning and NOV Letter Summary – 4th Quarter 2013

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.

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Weekly Roundup 1-3-14

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.

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A Look Back at 2013 and FDA

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.

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Weekly Roundup 12-20-13

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.

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