Eye on FDA

Is FDA Picking Up the Regulatory Pace?

It seems early in the oversight of the new FDA Commissioner and Deputy Commissioner to the agency turning a corner, or maybe not.

There have been two indications of possible increased enforcement that have emerged in the past few days that lead one to at least wonder if the FDA is getting more serious about enforcement. 

First, as mentioned in the Weekly Roundup on Friday, Caraco Pharmaceuticals experienced a seizure by U.S. Marshalls of product.  This occurred after a long period of regulatory interaction.  

Second, in the same week, the FDA issued a Notice of Intent to Revokethe biologics manufacturing license to Immucor regarding a facility in Georgia, also following regulatory interactions. 

Regulatory actions take time to organize and move in the bureacratic machinery and it could be that these efforts were in the works for a while and it is perhaps too early to determine if the FDA is picking up the regulatory pace.  But if we start seeing Consent Decrees, then we may be in fact seeing a sea change in enforcement.

Weekly Roundup - 6/26/09

We have had 3 days in a row without rain.  That is most welcome.  Today, I fear, we may lose our streak.  It has heated up in Washington and so has the debate on healthcare reform.  Another public figure who favors the sentiments of the Defense of Marriage Act goes down in lusty carnal flames. They are dropping like flies.   Meanwhile, here is a little of what happened in our world this week:

• Caraco Pharmaceuticals Has Seizure!  - The FDA announced that it had U.S. Marshals seize drug products manufactured by Caraco.  The action followed a number of voluntary recalls and was based on the fact that in the FDA's estimation, the company's current Good Manufacturing Practices (cGMPs) were not up to standard after an inspection in May found unresolved violations.   According to the company release on the matter, Caraco stated that "the company believes that corrective actions have been made and improvements are in are in process."  The company also stated that this only affects products from its Michigan facilities, though it is a Detroit based company and the release does not state where the company has other manufacturing facilities.  
• Schizophrenia Candidate Gets Complete Response Letter - In the very difficult category of mental health, H. Lundbeck announced that the company received a Complete Response Letter for its investigative compound Serdolect to treat schizophrenia.  While it does not appear that the agency was seeking safety or efficacy information, according to the company release, they did ask for additional data on the target population for the drug.  
• GSK Receives Complete Response Letter -  In a press release that was curiously titled "GSK Update for Rezonic", GSK announced receipt of a Complete Response Letter from the FDA for its candidate drug to treat nausea and vomiting following chemotherapy.  In what seems to be a standard statement style when receiving these letters, the company did not say if the FDA was asking for further safety or efficacy studies.  
• New Healthcare/Pharma Folks on Twitter - Genentech began a Twitter-feed in May that just came to my attention.  They have already developed a healthy number of followers since that time.  Also joining the ranks of Twitter is Siemen's Health.   By my count, there are now almost 20 companies on Twitter.   

Time for me to hit the trail.  Not the Appalachian one, I'm afraid.   

_____________________________________

By way of disclosure, it should be noted that Siemen's Health is a client.  

Opps for Apps

It is no state secret that the pharmaceutical industry is seriously lagging behind other industries - even other highly regulated industries - in making use of digital media to engage and support their stakeholders.  There are still many, if not most, that are not even using RSS feeds to issue news or to communicate internally with staff.   And as mentioned yesterday, there is a less than overwhelming presence on Twitter.  There is often the excuse put forth that pharma is hobbled by regulations (or lack thereof).  Ok.

A few days ago, I came across a new app for iPhone that I thought was amazing.  Dunkin Donuts, already recognized as a pioneer in its use of digital and social media, has come up with an iPhone app that is designed to help you organize group runs for coffee and donuts to the nearest Dunkin Donuts store and have your order ready for pickup.  It's called Dunkin Run.  Yes, that's right.   Brace yourself.  This is only the beginning.  Before too long I would imagine that there will be an app that takes you to any chain restaurant and helps you order and pay for your meal - lines will become a thing of the past.

What the hell am I talking about?  

Well, here it is.  It seems to me that as pharmaceutical companies are mostly being very shy little creatures about engaging in social media, they may want to start thinking a little beyond the most obvious ways to engage consumers in the social media to some that are less obvious.  Here are the things that pharma companies can and should be exploring.  How about some smart phone applications that 

- support and track a person's diabetes needs - from diet to levels;

- offer the capacity to help a person stay on a complex drug regimen (better than those branded little pill boxes they give out)

- support as part of a REMS program

- support to tell if a drug and/or OTC product and/or supplement might have dangerous interactions

- dietary weight loss compliance

- help in working with particular medical devices

Outreach to patients doesn't have to be limited to twitter, blogs and other forms of social media.  The realm of digital media is complex, evolving and increasingly integrated.  Pharmaceutical companies are light years behind, but with some innovative thought, the industry doesn't have to stay that way.  A patient might find a Facebook page engaging, but an app that helps her out on a daily basis would be more than engaging, it would be essential support and position the pharmaceutical company as more than a drug manufacturer, but a partner in care. 

There could even be apps for other stakeholders, like investors.  

Does everyone have a smart phone?  No.  But 20 years ago, most people didn't have a mobile phone and if they did, it was the size of a shoe box.  Smart phones are here and their presence and influence in commerce will be huge.  This is an opportunity for the pharmaceutical industry which should not continue to be the laggard in the race to innovate in digital media and by all means, should not wait for the FDA to find which way the wind is blowing in digital media.  The first to figure this out will make the others increase in irrelevance.  

FDA's Transparency Meeting

Tomorrow, the FDA is holding a hearing on transparency here in Washington, D.C and have issued their ground rules for participation.   The event is certainly a noble gesture and one does not have reason to expect that this time around, FDA is anything less than serious about the effort.  The FDA Transparency Blog has also opened up to take questions.  I have to admit, I have been so consumed with work and the blog that I haven't had time to enter a question to the Blog about transparency.

But as you may guess, my question would focus on why FDA's DDMAC issued untitled letters against 14 companies, about 45 brands, but (i) did not signal ahead of time any regulatory parameters for the action taken; (ii) has steadfastly refused to issue such parameters about emerging media; and (iii) refuses to discuss the matter and open the agency up to reasonable questions about same? 

The Internet has evolved considerably.  Why won't the FDA?

So that would be my question.  Sadly, I won't be there.  But I hope others ask something along these lines of reasonable question.

Good luck FDA and all who attend. 

The Growing Importance of Twitter

I happen to think that no element of new and emerging media is more important than Twitter - something that should be apparent to anyone involved in communications.

Enter into evidence the role that Twitter played in many recent news events - the Olympics in Beijing; the reporting when Lance Armstrong broke his collarbone; and of course the recent terrorist events in Mumbai.  The role of Twitter as a communications device reached an extraordinary standard when last week the U.S. government asked Twitter to put off a shut down for maintenance in light of the events unfolding in Iran.  

It is not just the astronomical growth of Twitter - the increasing number of users, but the growing applications of Twitter that are going to make it such a central function of mainstream communications in the future.   In fact, so many applications have been built for Twitter - allowing one to assess a person's influence, growth and importance, e.g., that an entire database and site called Twitdom has sprung up to help one assess and employ applications.  

Despite the enormous growth of Twitter, there are only about 16 pharmaceutical or device companies using it, which is astounding.  Those who are using it are employing it for purposes of a news feed (which is what many members of Congress are doing), while others are using it as a listening post (looking to see what others are saying) and still others are actually generating original content.  In my mind, it doesn't matter how you use it, just use it.

Or, if you think you can maintain a competitive advantage by relying on traditional media and read and be part of news today that happened yesterday, instead of news today as it happens, then suit yourself.  But in that case, I would remind you of a statement that a colleague of mine recently brought to my attention.  It is a quote from General Eric Shineski, Retired Chief of Staff of the U.S. Army -

 "If you don't like change, you're going to like irrelevance even less."