Upcoming AdComms By Subject Matter

In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so often.  It is just a different way of viewing the very useful calendar put up by FDA.  The February posting was notable because there were so few new product considerations while April saw a bump  up in that regard.  This time around there are NDAs, BLAs and PMAs.


  • Combination Drugs – On September 10, the Cardiovascular and Renal Drugs Advisory Committee will meet to discuss the potential clinical utility of fixed-combination prescription drugs that are composed of an an anti-hypertensive with a statin and aspirin to reduce cardiovascular events and death in patients with a CV history, focusing in particular whether such a product would have a benefit and various other questions related to the possible use.


  • NDA Approval Consideration – On August 14, the Pulmonary-Allergy Drugs Advisory Committeee will meet to consider an NDA submitted by Boehringer Ingleheim for tiotripium bromide inhalation sprace for the proposed indication of long-term, once-daily maintenance treatment of bronchospasms associated with COPD.


  • Regulatory Classification - On July 31, the Gasteroenterology and Urology Devices Panel of the Medical Devices AdComm will meet to make recommendations regarding the classification of a number of devices considered pre-amendments devices since they were in commercial distribution prior to May 28, 1976 when the Medical Devices Amendements became effective.  FDA is seeking input on the safety and effectiveness of the devices and the regulatory classification.  The devices include Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electical Sperm Collection, Erectile Dysfunction Devices and Alloplastic Spermatoceles.



  • BLA Approval Consideration – This week on the morning of July 31 the Blood Products Advisory Committee will meet to discuss the biologics license application of Baxter Healthcare for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune disorders.  During an afternoon session, the committee will be meeting in open session to discuss reentry of blood donors who had been deferred based on Chagas disease test results.




  • Adverse Event Discussion – There will be a joint meeting of the Drug Safety and Risk Management and the Psychopharmacologic Drugs Advisory Committee to discuss the risk of serious neuropsychiatric adverse events with CHANTIX tablets as well as options for addressing risk.



  • Safety Issues – There will be a joint meeting of the Bone, Reproductive and Urologic Drugs AdComm with the Drug Safety and Risk Management AdComm on September 17 to discuss the appropriate indicated population and potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
  • NDA Approval Consideration - On the following day, September 18, there will again be a joint meeting of the two committees to consider an NDA submitted by Clarus Therapeutics for a investigative oral testosterone replacement therapy treatment.
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Weekly Roundup 7.25.14

We sit on the cusp of August – the month when America goes on vacation.  Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the laziness of the season to an abrupt end.

But before that happens, let’s examine a few things from the week that might be of interest:

  • Link to Webinar on FDA and Social Media – On July 17 I gave a Webinar entitled “In More Than 140 Characters:  FDA’s Social Media Guidance Past, Present and Future” to which there was a large turnout, but also some folks who had signed up and could not make it.  For those, and for others who may have wanted to sign up but had a conflict, here is a link to a playback of the Webinar. To those of you who came, thanks for joining me!
  • FDA Approves Oxycodone with Abuse Deterrent – In a long-standing effort to create circumstances that make needed pain medication available that does not feed abuse as well, FDA this week announced approval of an oxycodone product that has abuse deterrent properties.  The product is an extended release/long-acting opioid analgesic called Targiniq ER and works by including naloxone so that when the tablet is crushed in any way for use, the naloxone blocs the euphoric effects being sought.  This does not preclude its abuse when taken orally.  The product is indicated to treat pain that requires daily, around-the-clock, long-term opioid treatment for which alternatives are inadequate and is not indicated for as-needed pain relief.  It is the second approval for extended release/long acting product approved since the agency’s 2013 draft guidance on Abuse-Deterent Opioids.
  • US and Mexico Sign Statement of Intent on Produce Safety – For those who remember the 2008 Tomato scare when tons of tomatoes from Mexico were destroyed in the belief that they were connected to an outbreak of salmonella – well there was a lot of criticism to go around.  This week FDA announced that FDA Commissioner Hamburg met this week with Mexican counterparts to discuss ways to strengthen cooperation in support of produce safety.  The news release outlines several areas of cooperation meant to put into place preventive practices which appeared more to be aims and goals than actual policies and procedures – an observation seemingly affirmed by the posting on FDA’s blog about the two-page statement of intent between the two countries.

It is a beautiful day here in Washington, D.C. and I hope that it is for you wherever you are as well.  Have a wonderful weekend.

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Developing a Policy for Correcting Third Party Misinformation

Last week I held my Webinar on FDA’s Regulation of Social Media called “In More than 140 Characters…”  During the 1 hour presentation, I attempted to cover a lot of ground, wanting not only to focus on the latest two guidance documents from this past June, but also to provide a comprehensive overview on where we are with the five questions raised by FDA in the November 2009 meeting.  It was an ambitious agenda and there were things that I wanted to cover in the presentation that had to end up on the cutting room floor.  Now there is time to take a look at a few of them and this is one.

One of the guidance documents was on a topic that had long been of interest to stakeholders of all kinds.  Can a company correct misinformation posted by independent third parties and if so, how to go about it?  Until now, many companies have been fearful of the unknown consequences of correcting misinformation and have opted to steer clear.

The guidance document issued by FDA in June on that topic made clear that a company can correct misinformation, but is not required to.  Moreover, if a company decides to correct misinformation, the agency also prescribed principles that must be met in order for a company to do so and be compliant.  In other words, whether or not to correct is a decision being left entirely up to the company – at least from the regulatory perspective. The presence of some degree of regulatory risk if one does act to correct misinformation means that companies will need to develop a policy for its approach.  The beginning of that approach is deciding what misinformation should be corrected.  Should it be all of which the company becomes aware?  Should it be none?  Is there an in-between?

This is not simple and there are a lot of considerations going into the development of a policy.  Here is one way to look at assessing the situation.

Let’s put it on an X-Y axis.  On one side of it – the X axis – let’s put a measurement of the severity of the misinformation.  This would involve creating a scale to assess the severity. Factors included in creating that scale might include- how many people are affected, the degree to which the misinformation could cause a harm and the seriousness of the harm.  The greater the potential gravity of the misinformation the further along the scale it would move.

On the opposing Y axis, we might consider the reach of the communicator.  If the misinformation was conveyed by someone in a venue that has only a small audience, it may not be particularly important to correct the misinformation.  However, a small audience is not the only factor to consider.  A small audience can nevertheless be extremely important if it is a potent one- i.e., that those people getting the message are likely to repeat it to a larger audience. It will be important to consider how to assess influence.

The end result may look something like this. There may be less of a compelling case to correct misinformation that falls into the green quadrant where audience exposure is low and the severity of the misinformation is also low.  Whereas a case could be made for that in yellow and that which falls into the red quadrant where both exposure and resulting risk is high might be misinformation of such a consequence that it is worth correcting.  In other words, this sort of exercise helps a company in assessing the risk/benefit ratio for correcting any particular incidence of misinformation.  A company has to develop its own criteria each of the axes.

This is not to suggest that this is the paradigm by which companies should operate.  Some may seek to correct all misinformation, others may decide to hold back until they see how FDA enforces the principles laid out in the guidance document on correcting misinformation, while others may choose to move forward.  Nor does this pretend to address all of the procedural issues associated with developing a protocol for correcting misinformation.

But the bottom line is this.  With the existence of the guidance, there is now a corresponding need for the development of some internal protocol by companies.  That protocol would not only cover which misinformation should be corrected (discussed here) – but also the matter of how that is internally executed – on how such information is monitored, and how it is corrected, and the record-keeping that should go along with it.

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Weekly Roundup 7.18.14

Well, the “poor man’s polar vortex blew through and frankly, while it did make life overall more bearable.  But the dogs, the lawn and the flowers all seem happier so that makes it ok by me.  I also had my Webinar this week and will be posting a link to a live replay for those who may have been interested and could not make it.   Hopefully I will have that by Monday.

In the meantime, here is a bit of what happened this week that was newsworthy:

  • Non-OPDP Warning Letter Issued Involving Social Media – Warning letters come from more places than the Office of Prescription Drug Promotion (OPDP) – an office which this year has issued only 5, the lowest rate in two decades – and many more are issued by FDA itself.  One such letter involved social media – as happens from time to time.  There are two primary sources for understanding FDA’s evolving point of view regarding practices related to social media – one is guidances which despite the recent flurry – have been not very forthcoming over the years – and the other is through warning letters, both from OPDP and from FDA.  This particular warning letter came out in June.  It is notable to the issue of firm responsibility for content – one of the 5 areas explored during the November 2009 FDA hearing on the Internet, Social Media and promotion.  Here this non-OPDP letter cited a number of issues associated with therapeutic claims the company made on its website, Facebook page and Twitter page.  But the thing to draw your attention to is the fact that the company “liked” testimonial comments for uses for their products which were not FDA-sanctioned, demonstrating an example of when a company can be held responsible for third party generated content.
  • FDA’s “OpenFDA” Provides Access to Recall Data – FDA’s blog FDAVoice carried a posting this week that announced that the agency is opening up access to information regarding recalls and enforcement reports.  Apparently at present the agency provided different ways to access information on recalls, including the RSS feed, but is now providing a new Application Programming Interface (API) that provides comprehensive access to the agency’s entire enforcement archive. There is a learning curve associated with its use, but it is interesting and covers prescription drugs, OTC products and more.
  • A Followup to the Smallpox Vials Issue – Earlier in the month it was reported that some leftover smallpox vials had been discovered dating apparently from the 1950′s in FDA facilities that had been transferred to the agency from NIH in 1972.  This week FDA provided an update on the situation, including the numbers of vials discovered and the fact that agents other than smallpox were included in the discovery as well as a statement on steps moving forward.
  • Dr. Woodcock Testifies on Modernizing Clinical Trials – This actually happened last week but the posting was not immediate – last week Dr. Janet Woodcock, the director of CDER, provided testimony before the House Energy and Commerce Committee’s Subcommittee on Health entitled “21st Century Cures:  Modernizing Clinical Trials and Incorporating the Patient Perspective” and it is worth the read on many fronts, including giving you a good idea of the rate of approvals in different markets around the world and the current state of approvals, among other things.

That’s it for me this week folks.  Have a wonderful summer weekend.

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Collection of FDA and Social Media Resources

Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going.  In June the most substantive guidance yet was released by the agency addressing two critical areas that were outstanding – the correction of misinformation by third parties about prescription products and medical devices, and addressing the challenges of including risk information in product specific communications where there are character limitations.

With the passage of so much time, however, and since digital and social media are expansive topics, it is somewhat difficult to keep track of everything that has occurred.  To help in that regard, I’ve put together a tab on the Eye on FDA blog site that contains the following:

  • Compilation of all relevant guidances
  • Links to relevant Warning and Untitled Letters
  • A link to my White Paper on the Regulation of Digital Media by FDA which compares enforcement patterns by OPDP for digital and non-digital communications vehicles;
  • Links to relevant pages on the FDA site that pertain to the regulation of digital media

If there are any other resources on the FDA site that I have overlooked, by all means I welcome suggestions.  In the meantime, I hope you will find this a useful resource.

Also, if you haven’t done so yet, there is still time to sign up for my free Webinar being given this Thursday, July 17 at 12 Noon E.S.T. – “In More than 140 Characters – FDA’s Social Media Guidance:  Past, Present and Future” where I will be taking a comprehensive look at FDA’s approach to regulating social media by examining each of the five questions raised in the November 2009 hearing held on the topic.

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