Mark S. Senak's Blog, page 43

Weekly Roundup – 11-1-13

We are in the last two months of 2013.  Because in my head it is still 1997, I find this hard to wrap my head around.  But not even a government shut down makes time stand still.  It is November 1 – long shadows are cast in the mid-afternoons and after this week, what will be do with a day shorter of daylight?  Today, there are a lot of kids all hopped up on sugar out there.  A lot of us left holding candy that didn’t get handed out. What happens to that every year?  So many questions….

And if you have questions about what happened this week, here are at least a few things:

FDA Announces Steps to Curb Drug Shortages – You may recall a few years back when the subject of drug shortages for critical drugs were in short supply, prompting an Executive Order from President Obama in 2011.  This week FDA announced two actions that the agency was taking to address drug shortages.  The first is a strategic plan which was called for in the Food andDrug Administration Safety and Innovation Act (FDASIA) passed in 2012.  According to the release, the plan is to work with manufacturers to promote sustained quality manufacturing.  The second action involved the issuance of a proposed rule that requires manufacturers to notify the agency of any permanent discontinuance, which was also part of the Executive Order.  There is a separate docket that has been established for the public to provide comment on the proposed rule that will apparently be open next week.
Not Very Good News About Spices - The Center for Food Safety and Nutrition (CFSAN) released a constituent update regarding the development of a draft risk profile on pathogens and filth in spices.  This risk profile was put together in the wake of recent outbreaks of human illness from Salmonella contaminated spices and suggests new mitigation and control options.  The study identified 14 outbreaks worldwide that were associated with spices occurring from 1973-2010.  You can read a copy of the report here and apparently provide commentary next week here.
FDA’s Role in Personalized Medicine – Sometimes I come across something on FDA’s site that is new to me, but I’m not sure whether it is really new or not since the agency typically does not date material, which is unfortunate. However, what they do tag on is a notice about when the page was last updated. Here is a handy overview of how the agency perceives its role in the developing world of personalized medicine, and the page was last updated 10/29/13 – so even if, unlike me, you are already familiar with this page, there is at least something new on it.

That’s it for me this week everyone.  I hope you manage ok with your leftover candy.  And for those of you in the northern hemisphere, have a lovely autumn weekend.

Photo by Anne Becker

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Catching Up on Google+ and Pharma

Back in 2011 when Google+ emerged from Beta and started offering branded pages, there was a good deal of commentary in the blogosphere about the potential use for the new platform by pharma – even here at Eye on FDA.  Now, nearly two years later, it seemed like a good time to check in and see what the experience has been.

Regular readers will recall the fact that Eye on FDA has devised a data base of pharma social media assets which includes profiles of all activity known to me in Twitter, Facebook, YouTube, Pinterest and Google+, tracking a number of characteristics.  It is important to stress this does not pretend to be the universe of activity – only that of which I have become aware.

There are 79 Google+ pages in the database that are sponsored by pharma companies.  Of these, it may surprise some that less than half (39) are from the U.S.  The number of followers range from 0-1198 – though a whopping 31 of these pages have no followers at all. The most circles that include one of the pharma companies is over 800.

Those are the numbers, but what about engagement?   One of the fields tracked is frequency of updates.  Pages were classified as Inactive, 1 Year Inactive, Rare Updates, Regular Updates, Weekly Updates and Daily Updates.  Removing the Inactive and Rare Updates leaves only 25 pharma sponsored pages.  Pulling out only those pages that update Daily or Weekly leaves only 8 pages, while daily leaves only 5.  By contrast, of the 123 Facebook pages being tracked, 34 of them had daily activity.

Two of the most active pages involve recruiting by companies – and one of them has one of the larger followings of any of the pages.  The pages tracked were also classified as to their primary purpose. As mentioned above, 2 pages are dedicated to recruitment efforts.  The vast majority – 52 pages – were pages set up about the company, while 17 were geared to specific products with all but 5 of those being OTC products.  Of the 5 RX product-specific pages, all but 1 were inactive.  In some cases, companies may just be “owning the real estate” without every being active.

Looking at industry activity on Google+ and comparing it to Facebook one sees that despite the fact that in 2011 many thought Google+ offered industry some unique characteristics, engagement at this point appears at a much lower level than other social media platforms.

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Weekly Roundup – 10-25-13

Well, there is definitely a bite of autumn crispness in the air and I think we are on the verge of first frost.  The days are noticeably shorter. Daylight savings (always thought it a funny name for it) is upon us very soon when we will Fall Back.  There are increasing numbers of leaves tracked into the house.  I have begun to think about stews and meat pies instead of creative salads and chilled soups.

And the government is back to work.  One can see a whirl of activity out of NIH and CDC electronic streams as well as FDA. So while last week the Roundup went quiet, here it is some of the agency catch-up:

Move to Reclassify Hydrocodone – The agency issued a statement this week announcing plans for FDA to submit a formal recommendation to HHS to reclassify hydrocodone combination pain products to move to DEA Schedule II. The submission of the recommendation will begin the process for DEA to make a decision.  FDA said that it has become “increasingly concerned about the abuse and misuse of opioid products” and noted that abuse had reached epidemic proportions.  The agency noted that DEA asked for a recommendation regarding the move back in 2009.
FDA Opens New Twitter Feed - Taking the number up to an even dozen now by my count, FDA opened a new Twitter feed called @FDAfood that allows you to follow the latest information on FSMA, food, nutrition, food additives and dietary supplements.  The feed has been included on two of @eyeonfda twitter lists – the list of all FDA tweets and a list of twitter feeds on the subject of food safety.
New Draft Guidance on Chronic Hep C Drug Development – FDA is announcing availability of a new draft guidance, which revises and replaces an earlier version, entitled “Chronic Hepatitis C Virus Infection:  Developing Direct-Acting Antiviral Drugs for Treatment” to assist sponsors in the development of new treatments.  The agency stated that significant changes exist in the new version.
Goodbye CFC Inhalers – The completed phase-out of all inhalers medical products containing chlorofluorocarbons (CFCs) will occur by December 31 of this year, said FDA in a release this week. CFCs were used as a means to propel drug from an inhaler into the patient – and have been mostly replaced over time with a substitute propellant.  FDA noted that while most inhaler products had already been phased out, there were two products still on the market – Combivent Inhalation Aerosol and Maxair Autohaler – which will no longer be available after the end of this year and the agency advised those using these products to talk to their health care professional about an alternative treatment.

I don’t know where the week went to.  I had all sorts of plans for postings.  But there is always next week.  In the meantime, have a good, relaxing, safe and fun weekend.

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Warning and NOV Letter Summary – 3rd Quarter 2013

Government shut down or no government shut down, the read for Warning and NOV letters out of the Office of Prescription Drug Promotion (OPDP) is slim pickings.

It is always a good idea at the end of the quarter to wait several days before doing the quarterly look-back because many times the agency posts the letters to the Web site several days after the date they were sent.  Since the shut down started at the beginning of October, that means that there could potentially be a posting that would involve letters from September.  But I’m going to take my chances and provide the look-back on what has been posted.

And that isn’t much.  FDA’s Office of Prescription Drug Promotion (OPDP) posted a total of three letters during the third quarter of 2013.  At an annualized rate that would mean that we would see a total of perhaps 17 letters this year, the lowest rate of any year since 1997 as near I can tell.  The chart contains 2013 numbers that are projected based on the rate of issuance so far this year.

Of the three letters from this quarter:

1 was a Warning Letter and 2 were Notice of Violation (NOV) letters;
1 letter involved an oncology product, one a product for MS and 1 was dermatological;
2 letters involved drugs with boxed warnings;
There were 4 communications vehicles involved in the violations – 2 digital – a Webpage and a banner ad,  and 2 non-digital – a Sales Aid and a DTC print ad

These letters involved a total of 10 violations, and here is how they stacked out:

3 Minimization or Omission of Risk Information
1 Superiority Claim
2 Overstatement of Efficacy
1 Unsubstantiated Claim
3 Other – including a Failure to Submit, Omission of Material Fact and a Misleading Claim

Lessons learned.  Amazingly, two of the letters involving omission of risk information were just that – omission of any risk information.  One, a print ad, failed to have any.  Another – a web page with banners had a link to full prescribing information which was demonstrated not to be sufficient back in 2009 when OPDP (then DDMAC) issued 14 letters regarding banner ads that made clear the agency did not accept links to risk information.

Once the government shut down is over, are we likely to see a recovery in the rate of letters?  There are a few factors to consider.  First, the slowdown in OPDP letters occurred way before the government shut down.  Despite the fact that these letters, along with guidance documents, are one of the few ways to gain insight into agency thinking, letters have simply not been forthcoming.  Second, OPDP does more than produce these letters – they review materials submitted by companies and there are thousands of pieces to review.  Third, presumably no one has been reviewing those pieces which means that when the government does return to some functional status, there may be a backlog to wade through.

Therefore, despite the fact that I have seen some communications materials that have surprised me, I would not to expect much of an uptick in the coming weeks or even months, perhaps making this the slowest year for regulatory action letters from FDA in many years.

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Weekly Roundup – 10-11-13

For Washington, it is real quiet.  This week on my way to work while driving past the Lincoln Memorial, there was a man with a lawn mower unofficially mowing the lawn.  The Federal Register which reports on all of the meetings and activities of the U.S. government is really tiny.  Surprisingly, traffic at rush hour does not seem to have lessened very much. Everyone seems perplexed by that.

Yet despite the inaction, there has been some limited activity, and here is a bit of it:

Approval for Pulmonary Hypertension Drug – The agency announced approval of Adempas (riociguat) for the treatment of adults with two types of pulmonary hypertension.  It is a first-in-class drug treatment – called soluble guanylate cyclase stimulators that help arteries to releax thereby increasing blood flow and decreasing blood pressure.  The drug carries a boxed warning and REMS program because the drug should not be used in pregnant women.
FDA Approves New Pediatric Use for Liposorber Apheresis System – FDA announced approval of Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before or after kidney transplantation where there is a recurrence of FSGS.  The condition as described in the release is one where there is scarring that develops on part of the kidneys causing a loss of protein from the blood into the urine.  A majority of children who have the condition will progress to end-stage renal disease and a high number of children affected who have a transplant experience a recurrence.
Senator Sends Letter to FDA Seeking Answers About Painkiller Meeting – Senator Joe Manchin of West Virginia sent a letter this week to FDA seeking answers to a series of questions in the wake of a Washington Post story regarding a meeting held to discuss painkiller clinical trials and efficacy standards that included academics, government officials and industry, but where industry was charged money to attend.  However, a spokesperson for FDA did make clear that the meeting was not initiated by FDA.

That’s it for me this rainy day in Washington.  Accept my wishes for a pleasant and restful weekend to you all.

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AdComms and the #Shutdown

People are looking for black and white answers about what government agencies in general are going to do during the shutdown respecting specific operations.  One of the specific areas of interest at FDA has been whether or not there will still be advisory committee meetings.

If you perform a Google search of “FDA Advisory Committees Government Shutdown” you will get a mixed bag in response – everything from FDA activities will continue to FDA postpones AdComms.  So it turns out the answer is not black and white.  It is gray.  It is maybe.  It is “it depends”.

FDA has put up a very nice and thorough page on “Medical Product Activities During the Federal Government Shutdown” that is meant to summarize agency activities during the “lapse period” as they have termed it.  In it, they state that FDA’s activities during the period will be limited to work involving eh safety of human life or the protection of property and activities funded by carryover user fee balances under PDUFA, GDUFA and MDUFA.

As to product reviews, the agency states that they “do not anticipate that the lapse in appropriations will affect our routine product review process submissions within the scope of PDUFA or GDUFA programs, provided that the applicable fees were paid before October 1, 2013.  This may lead some to report that the shutdown will not be affecting FDA Advisory Committee meetings.

But on October 8, FDA announced that it was postponing the Allergenic Products Advisory Committee set for November 5 and 6 “due to the government shutdown.”

Without knowing the specifics of that particular meeting, the bottom line would appear to be that AdComms regarding user fee products should still be able to continue if they were already paid for this year, though the logistics may be different or hampered in a way that makes them different from meetings in the normal course of things.  For example, the FDA press office has limited support at this time.  In the end, it would appear whether or not a meeting is going to occur is going to be assessed on a case by case basis, with the user fee question a key to that assessment.

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Final Guidance on Medical Apps

In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users.  Just over two years later in September of 2013 – after collecting and analyzing input, FDA released a final guidance regarding its approach to regulating medical apps.

Apps in support of patients are serving an increasingly important role and are a means by which medical product manufacturers can support patients as well as providers.  Apps are a way to provide personalized support that is also portable.  But the span of function that exists with apps is quite broad.  Identifying which categories apps get what kind of regulatory attention more specifically appears to be a way in which the final guidance differs from the draft guidance.

In the final guidance, FDA has created three primary categories:

Apps that are not medical devices – essentially apps that are informational or educational, but which are not used in making a diagnosis or medical determination  - FDA has created an explanation and provided examples in Appendix A of the Guidance;
Apps that are medical devices but over which FDA is going to exercise enforcement discretion – think of these as apps that go beyond information or education, but interact with the patient in a way to help them manage their condition.  An example from the Appendix might be the use of GPS to warn a patient about asthmatic conditions in the area in which they are currently located.  Here the agency says that it MAY exercise authority – but the key here appears to be the level of risk that the use of the app might pose to the patient if the app were faulty.  You can find examples in Appendix B of the Guidance or on this handy page put up by the agency.   
Apps that are medical devices over which FDA is going to exercise regulatory authority – these are those apps which are actually performing a medical function to diagnose and/or treat a patient – for example an app that might have a sensor or ability to interact that would allow the patient or provider to assess a condition.  You can find examples in Appendix C of the Guidance summarized on this page.

FDA has also provided a nice Q&A page and overview of medical apps. for those working in communications with manufacturers where apps may be a part of the plan, these three sections are key guides.

Those are the key differences for us communications folks, though there are some other new elements to explore for those interested such as provision for licensed providers who make their own app – and other technical legal aspects.  For those of us working in communications with manufacturers where apps may be part of a plan, the three sections above are key.

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Weekly Roundup – 10-4-13

What’s to round up during a week when there is a government shut-down and most FDA staff are off?  Well, not much, but I will go over a little and provide some thoughts about next week.

But first, remember a few weeks ago when I told you that a friend had named a newborn calf after me?  It was, and still is, quite exciting.  Here is my latest photo of Marky and as you can see, she is now sporting an earring proudly letting the world know her name.  I have the feeling Marky will be featured regularly in the Weekly Roundup!

The Federal Register carries daily updates on what federal agencies are doing – every meeting, etc.  It is usually notoriously long.  Now it is notoriously short.  No FDA mentions are contained in the Advance Federal Register and a notice on the landing page for the publication states that it will only be publishing notices related to activities that are necessary to protect against imminent threats to life or property.

There were no press releases, but there were some tweets from FDA this week.  You can follow the tweets of the agency on the Twitter List created on the Eye on FDA twitter feed, if you like that tracks all FDA twitter feeds and their tweets in one spot.

There is no way to know how long the shut down will last.  However, next week I will put up a few postings on the latest regarding the Med App Guidance and the warning letter summary, slim though it was, for the third quarter.  In the coming days, I will also post some insights from my pharma social media data base, as well as the warning letter data base.  So while FDA is furloughed, we will endeavor.

Photo of Marky by Anne Becker

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Keeping an Eye on FDA When There is No FDA

It would seem like an obvious challenge to write for a blog called Eye on FDA when in fact, there is a government shutdown.  That said, an agency that regulates one-quarter of the U.S. economy does not come to a complete stop.

Warning Letters. For example, as a subscriber to notices regarding warning letters, I did receive an email this morning stating that the Warning Letters page had been updated.  These were general FDA warning letters, not letters posted by the Office of Prescription Drug Promotion – for which the latest letter posted was July 31.  However, sure enough, the general warning letters page lists its last update as being October 1.

Twitter Feeds. There was a notice put out yesterday, via Twitter, that all U.S. government twitter feeds would be inactive during the shut down, which includes all of the 11 FDA sponsored feeds, it would seem.  However, a tweet did go out this morning from @FDA_Drug_Info.  If you would like to monitor any FDA twitter activity during the shutdown, the @eyeonfda twitter feed has a compilation list of all FDA tweets where you can follow them all in one place.  The @FDArecalls feed stated that it would be posting limited notices and would not be monitoring or responding to tweets.

Press Office. I am informed that the media office is quite minimally staffed and that they will be issuing press releases related to actions funded by user fee programs.

Drug Applications and User Fees. Speaking of user fees, in the Drugs section of the Website, under Information for Industry, there is the following statement – and please note that the emphasis by underscoring was added by me:

In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution (“lapse period”) agency operations will be limited to the following:

Emergency work involving the safety of human life or the protection of property;
Criminal law enforcement and work; and
Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Animal Generic Drug User Fee Act (AGDUFA) and Family Smoking, Prevention and Tobacco Control Act.  Carryover user fee balances will only be spent on activities for which fees are authorized under the Federal Food, Drug and Cosmetic Act (FD&C Act).

With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted.  This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.

Lapse Period. While new developments out of FDA may be difficult to report on, I will endeavor during the “lapse period” to shed light on (1) any changes and (2) looking at past FDA activities that could shed light on communications efforts for those working with industry by looking in-depth at the Warning Letters data base I have developed for any gems, among other things.

Let us hope that the lapse period lapses soon.

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Further Information on the Shutdown and CMS/HHS/FDA

While not a news breaking blog, when interesting and timely information comes my way – it is for the sharing.  This from my colleague Kip Piper of The Piper Report.

This is, of course, in the event that the Congress fails to pass a continuing resolution in time to become law for October 1, there are some specifics – via Kip – regarding how CMS and FDA might be affected.  There are functions that have been deemed essential functions that will continue – and still others that have separate funding that will not be affected.  From Kip:

Sixty-five percent of CMS will be placed on unpaid leave which comes to 3,881 of 5,994 staff.
Federal Medicaid and CHIP funding continues due to an advance appropriation received.  Medicaid and CHIP are mandatory programs with annual appropriations whereas Medicare does not have such an appropriation);
Medicare will continue largely without interruption if the shutdown remains in the short term – a longer term shut down could impact operations;
Center for Medicare and Medicaid Innovation grant programs are not affected;
Forty-fuive percent of FDA staff will be on furlough;
Most FDA drug and device related functions will continue since they are largely funds through fees;
Critical consumer protection functions will be continued on a select, priority basis with examples being public health emergencies, high risk recalls, import entry review and civil and criminal investigations;
Most FDA activities on food safety, nutrition and cosmetics stop, including routine inspections and monitoring
And large portions of the Affordable Care Act will continue.

Thanks Kip!

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