Eye on FDA

FDA Pioneers New Level of Transparency - An Interview with Dr. Joshua Sharfstein

No kidding.  I mean it.

Transparency is one of those buzz words that doesn't really mean much to people, because it means so many things to so many people.  As a result, in some ways, the word has lost its relevancy.  So one is hesitant to even use the word "transparency" to describe the new effort launched by FDA earlier this month called FDA Track.  It is transparency, but it is so much more.  And to those of us whose lives and livelihoods revolve around the workings of this agency, FDA Track is an incredible new tool filled with a great deal of promise.

This is more than transparency, it is really about program accountability.  With FDA Track, you will be able to look in on your pertinent parts of the agency to see how they are tracking by checking out one of the many dashboards that has been formed for the many FDA program offices that will be reporting through the program.  For example, I zeroed in on CDER, which has ten reporting dashboards, including one for the Office of New Drugs.  Using this, one can track investigational new drug applications as well as NDAs and BLAs to see the numbers on how the FDA is doing.  Here is a screenshot of what that looks like and some of the metrics involved:

Not interested in new drugs, but more interested in generics?  There is a dashboard for that as well.   In fact, there are a few dozen dashboards that convey a lot of information on the progress of the agency over time.  

You can see that there are a lot of N/A's and TBD's, but the numbers should start rolling in soon. And if there is a metric not there that might be useful, the agency is apparently open to suggestion at any rate, on the possibility of adding new measurements.   

In looking it over, I had to wonder if any other federal agency has gone so far in publishing some of the areas in which it was already collecting data on  how the agency itself is doing.  That is why I think this might be somewhat pioneering.  

I had the opportunity last Friday to sit down with Dr. Joshua Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration to discuss FDA Track. We talked about the genesis of the program, how they are doing it, what those of us in the public who are interested can expect of the program, and the process and timeframe for bringing it entirely up and running.  Check it out.

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A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0

At the bottom of this posting is a podcast with the FDA on Web 2.0 and pharma, making it an important posting for anyone connected with communications by pharmaceutical companies - advertisers, regulatory and legal departments and marketing whether in the U.S. or not.

As a highly regulated industry, the pharmaceutical industry has been highly reticent about participation in Web 2.0 though social and digital media to reach out to patients, physicians and other stakeholders. But there are many moving parts that, taken together, really demand the digital presence of the pharmaceutical industry or risk brand dilution:

• The Communications Revolution - First, traditional means of communications are changing rapidly.  Broadcast and print journalism that offers pre-packaged news to broad audiences do not offer the consumer the ability to pick and choose the news he or she can use. Broadcast and print are often aimed at the lowest common denominator. Socially, large institutions have lost the trust of the general population and there is a drive and an ability in the digital realm to pick and choose news and news sources as well as topics from sources that you trust - with the added feature that you as the consumer are also a participant in dialog, rather than old world news that was a one-way street.  There is also a speed to digital to which traditional media cannot match.  A blogger, for example, has no editor traps to run through which, while it might be a two-sided coin, certainly means that the blogger is more fleet of pen.  The bottom line here is that there has been a huge and continuing shift to new and social media for both news and conversation.  People no longer just read news, they are now more active in spreading it.  Meanwhile, revenues in traditional journalism are down, papers are declaring bankruptcy, paring down issues or going completely digital.

• The Policy Environment- Second, for pharmaceutical companies, the policy environment is poised to change, significantly altering two main routes of communication to patients - one being Direct-to-Consumer (DTC) and one being the relationships that pharmaceutical companies develop with prescribers through their professional medical societies and through direct marketing.  As Congress moves to reform these areas, the only alternative for pharmaceutical companies is to communicate with both of these audiences in the digital environment.  

• Patients Seek Information Online - According to the Pew Internet and American Life Project, not only do people use the Internet to seek information about healthcare options, but people with chronic illnesses are more likely to access and act on information they get from the Internet.   If people are going to that space for Web 2.0 communications and the pharmaceutical industry is only up to Web 1.0, well - then they are leaving their brand to be shaped by almost entirely by outside forces.  And one need only look at the proliferation of medical on-line sources and communities such as Medpedia, Wikipedia, Sermo and Physician Connect to know that the conversation has moved.    

Despite the crushing amount of incentives to go digital, the pharmaceutical utilization of social media and Web 2.0 has been hobbled by regulatory concerns that participation might necessarily trigger FDA action in the form of a warning letter.   There have been a few pioneers in the space, but the majority of pharmaceutical firms are not engaged and sit paralyzed as control over their brands ebbs away into the ether.

To date, FDA and the Division for Drug Marketing, Advertising and Communications (DDMAC)has been relatively quiet on the subject.  While the agency has a number of guidances on a wide variety of topics, there is nothing on this topic.  In such a vacuum, many have made assumptions about the use of social media and for many, any time the subject comes up - it is a non-starter.

To help to begin to clarify the situation, it seemed like a good idea to sit down with FDA to get some of their thinking about Web 2.0  The result is the following podcast with Dr. Jean Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development.  

 

There was no expectation, of course, that the FDA was going to issue a guidance in the context of a podcast, but it did seem important to start getting some definition to the environment where there has largely been only speculation.  So I began by asking about the appropriateness of social media engagement by  pharmaceutical companies; about the nature of multi-media releases; about the real fear among many companies that if they generate and post original materials that they may later be changed by others; about the FDA's plans and how companies can get help in making their own.  

 

Obviously, understanding the complete FDA point of view about Web 2.0 and pharmaceutical companies is going to be a process, not an event.  A comprehensive set of answers to the many outstanding questions cannot be gotten in one sitting.  But this is a good beginning for gaining some insights into this most important communications, marketing and regulatory issue.  

The podcast runs 15 minutes, but it will be time well-spent.

By the way, I absolutely expect waves of love for this...

 

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J&J and Social Media - How'd They Do It? A Conversation with J&J

Johnson & Johnson has gone far in establishing a digital footprint that has both breadth and depth to it.  The company's YouTube channel now has over 90 videos - not branded, but patient educational. That is more than SanofiPasteurTV, GSKVision and the AbbottChannel combined.  They have multiple Facebook pages that are geared to special audiences, consumer products and conditions.  They have a corporate blog - JNJBTW.  The blog was begun with the simple question that serves as a premise - Everyone else is talking about our company, so why can't we? 

Generally these media are linked to one another, driving traffic back and forth.  And the company is establishing relationships and communications with other stakeholders.  

There continues to be concern about a highly regulated industry like pharma becoming involved in social media.  The regulatory cultures of some companies are so conservative that employees aren't permitted to view social media.  Other companies, like J&J have tested the waters.  Curiously, no regulatory wires have been tripped solely for the reason of the medium.  

Marc Monseau is the Director of Corporate Communications for Social Media at J&J and Rob Halper is the Director of Video Communications.  Just the fact that such titles exist at a company that makes pharmaceutical products is a testament to vision.  I have had it in my head for some time to get the opportunity to have them talk about their experiences in developing their company's digital footprint.  Yesterday, we got to do it.  We talked about what motivated them in the first place - how they began - and what they encountered along the way.  I hope you find it useful and informative.

What Would Congress Do? - A Conversation With Dick Gephardt

There is a lot of change going on.  Driving past the mall today, one could see lines of tents being erected on the mall.  I recently took a photo while walking past the Capitol of the scaffolding as it was being constructed.  The new Congress is already seated and next Tuesday begins a new era.  What will it look like?   What is change?

On December 15, I attended a forum held at the Franklin Institute in Philadelphia called Best and the Brightest Forum on Medical Innovation.  There were two panels for the day - the first to talk about obstacles to medical innovation for the future, the second to suggest solutions.

The first panel did do an excellent job of pointing out many of the obstacles, including the looming financial crisis and its impact on the U.S. to recruit and retain good scientific talent.  I was not able to stay for the entire second panel, but from what I heard, they were less successful in identifying solutions.

The moderator of the panels was Congressman Dick Gephardt.  Congressman Gephardt was a member of Congress from 1977 until 2005, during which time he served as both the House Majority and Minority leader.  We sat down together for a few moments to discuss some of the topic of the day - specifically what would the priorities be in the new Congress and do the issues of the day stand to stifle rather than enable medical innovation. 

Congressman Gephardt offered his view about whether or not the financial crisis would take prioritiy and thought that the Congress and the new Administration would act in a way that would support innovation and provide solutions to existing problems.   It is a short, succinct podcast and I thank the Congressman for taking the time to spend with me on a busy day.  I was delayed by a computer problem from posting the interview sooner than today, but it is nevertheless, quite timely.

Weekly Roundup - 09-12/08

Well, Congress is back.  You may be relieved that your representation is back at the seat of government, doing that voodoo that they do so well.  For me, it means a longer commute and more bad drivers on the road.  We had torrential, biblical rains here in DC from Hurricane Hanna.  We begin to turn our attention to the change of seasons.  Mums are for sale everywhere.  And today, I start Motorcycle Class man.  I'm too cool for school.

In the meantime, here is a little of what happened this week:

• Podcast with Wayne Pines - If you have anything to do with FDA, then you know Wayne Pines, a consultant to many healthcare interests on matters dealing with the FDA and media.  I had the chance to sit down with him this week and we talked about how quickly both the regulations that govern FDA and modes of communication are changing the face of what healthcare communicators do and what they need to know about.  Enjoy.

• FDA Issues Alert Over Chinese Infant Formula - In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.  The FDA is advising caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States as mentioned below. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.
• Job with My Employer Fleishman-Hillard - I don't usually do this sort of thing, but since I've been writing so much about digital and healthcare, here is a job available that involves both for those qualified and interested.  Here is the job information on the position.

It has been a rather unpleasant week for me, so I'm signing off. 

A Conversation with Dr. David Kessler, Former FDA Commissioner

Last week, my employer - Fleishman-Hillard, held a public affairs briefing in Washington, D.C. that included several of the members of the International Advisory Board (IAB) for the firm.  The event was co-hosted by the Capitol Hill newspaper  Roll Call and was moderated by Morton M. Kondracke, political commentator and executive editor.  The IAB is made up of people from various industries and past administrations and some of them were assembled to discuss the challenges and priorities that exist for the next elected Administration on several fronts - from healthcare to foreign affairs to finance to trade.

I sat down with several of the IAB participants that day to record their thoughts, and one of them was Dr. David Kessler, former FDA Commissioner from 1990 until 1997, appointed first by President George H.W. Bush and re-appointed by President Bill Clinton. 

It seemed to me that Dr. Kessler led the FDA during much happier times, when the agency was indeed the gold standard.  I asked him to compare the level of scrutiny and Congressional oversight of the FDA today to the time when he was Commissioner.  We also, naturally, discussed the challenges that the FDA faces now, the questions of credibility and the role of leadership, the evolving role of the FDA in a global economy and the prospect of FDA reforms.

Enjoy.

Does Cholesterol Matter? A Conversation with John Carey of BusinessWeek

Every time I hear the sound of my recorded voice, I am reminded why I write so much.  I am still quite rough at the edges.  Nevertheless, I've had the courage to do another podcast, this time with John Carey, senior correspondent at BusinessWeek. 

Cholesterol and statins have been in the news a good deal lately.  Last week, I wrote about the study release about Vytorin, calling into question whether or not it was effective in preventing heart attacks.  The Forbes article headline was that "Study Shows Vytorin Has No Benefit" even though there are emerging studies that demonstrate or suggest other possibilities. 

The January 28, 2008 cover story of BusinessWeek ran a story the title of which raises the question without having the same conviction as the Forbes article.  It is by John Carey entitled "Do Cholesterol Drugs Do Any Good?"

It is a provocative article that does ask important questions.  In it, John Carey explores the efficacy claims of cholesterol drugs when viewed through the lens of the "Number Needed to Treat" (NNT) - which means how many people actually have to take a drug before there is someone who sees a benefit.

The article suggests that the way we traditionally evaluate and promote efficacy may be by means of  too blunt an instrument.   

On the other hand, also this month, data was released to show that deaths from heart attacks and stroke have plummeted in this country - as well as studies that speculate whether there is a role for statins in cancer prevention.  Coincident with that drop has been an uptake in the long-term use of statins among other things, such as improvements in treatment of heart attack and stroke patients. 

Few public health messages have been pounded into consumers heads more than that which says lower cholesterol lowers your risk for heart attack.  I invite you to listen to Mr. Carey as we discuss his article, the role of blockbuster drugs and what this might mean for the future.

And for communicators, whether you agree with the points raised in the article or not, the discussion raises new questions about how we talk about benefits and efficacy - questions that need to be answered.  Will, for example, NNT capture the role of statins, if any, in the longer term statistics (from 1999-2005) that show a 25% drop in heart attack and stroke deaths?  What should be included in the mix when we define benefit and when we define risk?

I had the opportunity, thanks to colleague Ben Finzel, to sit down with Mr. Carey and discuss just a few of the ramifications of these questions: 

Dr. David Acheson

Last week, I had the good fortune to sit down with Dr. David Acheson, Assistant Commissioner for Food Safety at the Food and Drug Administration. I had wanted to meet him ever since reading about him in the Washington Post in July, 2007 in an article entitled "Meet David Acheson:  Your Stomach's Best Friend"

Since then, there have been a number of issues emerging connected with food safety - imports from China, e-coli outbreaks and the like.  As 2008 approaches, it seemed like an opportune time to get his thoughts on the FDA's priorities for food safety in the coming year.

During out discussion he outlined plans by the FDA for future protections and he covered ground related to consumer confidence - what has shaken it and what it will take to restore it.  We talked about Chinese imports in the context of today's global trade environment. 

I think that in the wake of some of the FDA reform aimed at the pharmaceutical side of the FDA mission has taken place this year, in the coming year, there may be a shift by policy-makers to addressing the issue of food safety, with reform perhaps being the creation of a single food agency, rather than the current system of food jurisdiction split between FDA and USDA.  You will hear his thoughts on that front as well. 

He is an extremely eloquent and interesting individual.  Enjoy the podcast.

A Conversation with Jim Greenwood - BIO CEO and President

The newly passed legislation in Congress that will reform FDA and reauthorize the Prescription Drug User Fee Act for another five years is just one example of dynamic change that is occurring in the marketplace. 

This week, I was able to speak with Jim Greenwood, President and CEO of BIO,(representing over 1100 biotechnology companies) to talk about the impact of the reforms - what went into them, and what did not (i.e., a regulatory pathway for follow-on biologics).   We also discussed public perceptions of drug safety standards and how the COX-2 safety scares have shaped the public and policy maker psyche.  Lastly, we discussed how the struggling image of the medicines industry affects public policy outcomes. 

Mr. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005 where he served as a senior member of the Energy and Commerce Committee.  From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's vast jurisdiction.

A Conversation with Pill Book Editor - Dr. Harold Silverman

I had occasion to have a conversation with Dr. Harold Silverman, editor of The Pill Book - a perennially popular resource for consumers to learn about the medicines they are taking,  now in its 12th edition. 

We of course talked about the book and some of its aspects that make it so useful for people, in spite of the advent of the Internet.  We also talked a bit about the development of new drugs and whether or not the FDA has become too risk averse.