Something very good happened and something kinda bad for me yesterday.  The good part is that I had the opportunity to sit down again with Dr. David Acheson, Assistant Commissioner for the FDA in charge of Food Safety.  The bad part is that during our conversation, my digital audio recorder malfunctioned and I lost the very first few moments of our conversation.  Total bummer.  Fortunately, the malfunction occurred within a few minutes of our talk and the bulk of it was in the second, signaled by me saying "go on" to Dr. Acheson.  What can I do?  I don't make the recorders.

I sat down with Dr. Acheson not because the salmonella issue is still hot news.  It, like the summer, is over, at least according to the CDC on the latter front.  But it seemed like a good time to look back at what happened.  And there is little doubt in my mind, that it will serve as a milestone in coming discussions on the Hill about the reform of FDA.  After all, the salmonella crisis was serious - tomato producers lost money, there was a sickening loss of crop and the American public and key stakeholders and policy makers were doubting whether or not the FDA was in a position to really protect the public health on food.

What followed were hearings and lots of news coverage.  What I saw was Lou Dobbs criticizing the FDA and those who work for it and congresspeople hammering questions to representatives of the FDA.  As anyone who reads this blog knows, I am a critic of the agency and the way it has handled itself the past few years.  But, the efforts of media and members of Congress struck me as particularly unfair.  I think that the FDA has had little opportunity to communicate what happened.  That is why I interviewed Dr. Acheson.

Now, then my recorder had it's Rose Mary Woods moment.  Here is what we talked about during the first few minutes of our interview.

Dr. Acheson outlined what happens at the beginning of an outbreak like salmonella.  First, a few people eat an infected food.  From all of those that eat that food, a relatively small number will be sick enough to go to the doctor.  When they go to the doctor, he/she may take tests such as a stool sample, that then come back to the physician.  The physician then makes a diagnosis.  The number of those diagnoses, if there are enough, become a signal.  From the time of that signal, public health officials then take notice and let us know that there is a problem, where the CDC. the government arm that monitors outbreaks and covers epidemiology, takes note of an emergent pathogen.  The CDC then tells the FDA that there is an issue.  At that point, the FDA begins the investigation into where the problem originated and begins to talk to the patients about what they ate. 

Listen to the podcast.  It is long, but if you are interested in this issue, it is illuminating.  My apologies to Dr. Acheson for my recorder, but the meat is here.

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By way of disclosure, during the salmonella crisis this summer, I worked with a member of the produce industry. 

In any case, today, J&J has launched a new Facebook presence with VISTAKON®,  part of the J&J empire and maker of ACUVUE® Brand Contact Lenses, today announced the launch of ACUMINDER™ .  This from the press release:

ACUMINDER™ was introduced last year as a complimentary online service designed to help improve contact lens compliance and eye health for the nation’s 38 million contact lens wearers. Now available as a Facebook application, ACUMINDER™ users can receive reminder messages via e-mail and/or alerts in their Facebook newsfeed.  In addition to helping consumers with contact lens compliance to help avoid potential eye health complications, ACUMINDER™ Facebook reminders can pertain to just about anything, including taking daily medications, doctors’ visits, work deadlines, important social events and more. Reminders also can easily be sent to other Facebook users

Contact lens wearers who do not use Facebook can still register for the free service at www.acuminder.com and elect to receive an automatic reminder about changing or ordering new contact lenses via e-mail, cell phone text message, and/or a computer desktop prompt.

This might be seen by some as risky, especially if a problem emerged with contact lens use.  In fact, the FDA has an entire set of resources for contact lens wearers to help make decisions about which lens makes sense, etc.   But I would argue that by engaging the digital community so completely, J&J is poised to communicate more effectively and efficiently with consumers during any possible crisis as they move into a more interactive level of communication than they could with a plain old Web site.  Plus, the move engenders the trust of consumers and brings the brand closer to them.

One last smart thing they are beginning to do.  They are integrating their communications approach digitally speaking.  The blog carries news of the Facebook developments and the players of each are moving amongst each of the media.  Advice on the YouTube channel may also appear on the blog.  It is only a matter of time, I think, before J&J begins to twitter as well.  It is, after all, much faster than a press release.  And there are a few media outlets now following me on Twitter. 

For those slower to move into this space, speed up.  You are behind.  For those in it, start figuring out what you are going to do - develop a strategy (let me help you even!).  And for those too reluctant to try, go home and watch your black and white television and ponder retirement.

Even given the time of year though, there are a few things going on that I want to report, and I want to use the Weekly Roundup to regularly update readers as to what is new on the Eye on FDA YouTube channel, which in one week has picked up more subscribers than any of the pharmaceutical companies posting vids and more than the FDA.  Woo hoo!  Thanks everyone!

And, I also have a new personal record of the number of folks following me on Twitter, among whom are PRWeek, WUSA9 in Washington and NBC4.  Thanks everyone!

Here is a little bit of news:

• FDA Set to Hold Public Meeting on Children's OTC Cold Medicines - A joint meeting of the Pediatric Drugs Advisory Committee and the Non-prescription Drugs Advisory Committee will occur to discuss the safety and efficacy of over-the-counter (OTC) cough and cold products marketed for pediatric use. held on August 25 that it is holding a public meeting on OTC cold medicines for children. The meeting will be held on October 18 and 19, 2007,
  from 8 a.m. to 5 p.m. at  the National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Ave., Silver Spring.
• FDA Clears Test to Help Doctors Manage Heart Transplant Patients - The agency announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.  XDx Inc. of Brisbane, California developed the device called AlloMap using blood and biopsy samples and other information collected from heart transplant recipients at nine U.S. heart transplants centers participating in the Cardiac Allograft Rejection Gene expression Observational study (CARGO). CARGO provided data from 153 patients on 300 medical visits at various times after heart transplant study. 
• FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts - Also this week, the agency approved Amgen's Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.  This approval demonstrates a company successfully managing the RiskMap process - see this from the FDA's press release about the approval.

  During six months of treatment, patients who received Nplate had significantly higher platelet counts and maintained those higher counts compared to those who did not receive the drug. The response to Nplate was higher in those patients who still had their spleen than in those patients who had undergone a splenectomy. In those patients who did not receive Nplate, only one experienced a sustained increase in platelet counts.

  Safety concerns with Nplate include fibrous deposits in the bone marrow and the possibility that once Nplate is stopped, platelet counts could drop below what they were before beginning treatment.

  Additional risks include blood clots due to excessive increases in platelets and, if Nplate were given to patients with an abnormal blood condition known as myelodysplasia, a risk for a form of blood cancer known as acute leukemia. Myelodysplasia, which is associated with low platelet counts, predisposes some patients to leukemia. In a study of 44 patients who had myelodysplasia and received Nplate, four patients developed leukemia. Further clinical trials in patients with predisposing conditions for leukemia will be needed to determine whether the development of leukemia may relate to the use of Nplate. Nplate is approved only for use among patients with chronic ITP.

  A Risk Evaluation and Mitigation Strategy (REMS) has been developed to address the risks of Nplate therapy. Under the Food and Drug Administration Amendments Act of 2007, FDA has determined that a REMS is necessary for the benefits of Nplate to outweigh the risks of the product. The REMS will include a Medication Guide for patients and requires that all prescribers and patients enroll in a special program to track the long term safety of Nplate therapy.

• Several New Vid Posted to EyeonFDA YouTube Channel - I'm not going to list each individually, especially right now as I'm aggregating health videos from several sources to build a large collection of vids on a variety of topics.  However, this week I added about two dozen vids and added a new playlist on Alzheimer's Disease.  I also added several diabetes vids, especially in the wake of the fact that the LillyDiabetes channel got pulled.  And I've added several corporate vids to the playlist, especially those of Abbott.   I also issued a Web News Release about the launch of the YouTube channel - check it out .

That's it for me today folks.  Have a good long weekend.  Next week we're back to school and Congress will be returning and all in all, life in Washington will CHANGE!

The Abbott channel only has a few vids posted to it, specifically 8 - 3 of which are about their stent product, one about baby nutrition, one on diabetes and a few HIV-related PSAs from their I Stand with Magic campaign.  It is a pretty soft offering, but perhaps one that will improve with time as they find their voice.   There has obviously been no launch, apparently not even an internal one with only 7 subscribers, so I would repeat the advice I outlined in my posting about LillyDiabetes. 

This is the second Complete Response Letter that J&J has received this month, the first being for Doribax.   By comparison, the information in the press release issued today for the NDA for paliperidone palmitate was far less forthcoming than that of the earlier CRL received by the company for Doribax. 

Text of today's press release:

FDA ISSUES COMPLETE RESPONSE LETTER FOR PALIPERIDONE PALMITATE FOR THE TREATMENT OF SCHIZOPHRENIA - Titusville, NJ (Aug 26, 2008) - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional data before it will approve the company's New Drug Application (NDA) for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for treating schizophrenia and preventing recurrence of its symptoms.

The letter outlined remaining questions that need to be addressed prior to granting approval for paliperidone palmitate. The agency does not require any additional studies.

J&JPRD is currently evaluating the FDA complete response and intends to work with the agency to resolve any outstanding questions. The NDA for paliperidone palmitate was submitted in October 2007.

Paliperidone palmitate utilizes the NanoCrystal® Technology patented by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.

Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the U.S. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

The contents of approvable and not approvable letters were proprietary, but receiving one over the other at least signaled the FDA's point of view about the NDA to some degree (though products that received not approvable letters sometimes did go on to achieve approval status).  The content of CRLs is also going to be proprietary.  That means that outside observers are reliant on what the company says about the CRL for insight into the drug product's future and for investors, there is less certainty as the name of the FDA's response is much more generic than the previous Approvable/Not Approvable status.

A CRL is supposed to outline a pathway to approval, unless the NDA is thought beyond redemption by the FDA.  But what that pathway is will not be apparent to outside observers.  What the company says about what the letter says may have a great deal of impact on the company's stock and on the view of analysts. Saying too much may be discouraging and may give competitors an advantage, but saying too little may indicate that the company is fearful or that there was no pathway outlined because the FDA deemed the NDA to be so insufficient.

For companies associated with drug production rather than biologics production, it is a good idea to begin to formulate a policy and set of standards for how the company is going to communicate about the contents of CRLs.  There should be a process in place for assessing and making decisions about a CRL communication before one is received, not after.    Perhaps some lessons can be derived from biologics companies that have received them, but in any case, be aware that the way that a company communicates the contents can make all the difference to its stock value on the day of the announcement.

For investors, you will need to develop a way to read the tea leaves of the press releases from companies.  According to the excellent RPM report, you may want to consider whether the company mentions site inspections or brand name approval for why would the FDA approve the brand name or bother to inspect a site if it weren't intent on eventual approval.  There will be a great deal of nuance in the letters, and you would do well to look at the press releases of biologics companies who have received CRLs in the past to get a feel for what is communicated.

It is not a matter of potato/potahto, tomato/tomahto....

And speaking of RPM Report, see Tracking Troubled NDAs:  New FDA Regs Mean Less Clarity for Investors by Cole Werble for an excellent discussion of CDER's new final rule.   

According to the press release, this is a "strategic production alliance."  The aim of the agreement would appear to allow the Chinese company to manufacture chemical intermediates for eventual use in eventual drug products. 

There is nothing surprising about this, and in fact, it is done already and makes perfect sense in today's globalized economy.  But I think for companies doing this, in the wake of the heparin issue, there is both a challenge and an opportunity for companies as they embark on these kinds of agreements. 

Challenges first.  If components of compounds are being made in foreign countries, then some in the U.S. might ask what could be the problem in individuals purchasing their drugs from outside of the U.S. at lower prices.  Second, in the wake of the heparin issue, the FDA went to great lengths to announce that it was opening offices in China and sending personnel there. 

That leads to the opportunity.  There is no question that the volume of work to be done through foreign inspections will quickly outstrip any capacity on the part of FDA to inspect foreign manufacturing facilities, meaning that private industry using foreign companies for the supply of raw materials will need to step up to ensure quality and safety under these circumstances.  Again, from the press release:

From September 2008 onwards, Boehringer Ingelheim will supply know-how as well as technical support for production to Hisoar. Hisoar in turn will invest into new specific production facilities for Boehringer Ingelheim at its new site in Chuannan. The production for Boehringer Ingelheim in Chuannan is planned to start in early 2009.

Mr. Bangpeng Luo, the Chairman of Hisoar commented: We are very pleased to have the opportunity to cooperate with Boehringer Ingelheim, a large multinational pharmaceutical company. This cooperation, both from the technical and the management level, will raise Hisoar’s market positioning and standing and it will create an unusual benefit for Hisoar to enter the international level of raw material suppliers, and indicates that Hisoar has come a big step forward towards internationalization.”

The announcement of the cooperation agreement is a good step at demonstrating the company's role, though it might have gone further in specifically addressing quality control and standards.  And it might not be a bad idea to provide updates that specifically allude to quality control that can bolster the case for what has become in today's economy, a standard practice of manufacturing. 

I owe an apology - this one was started back in June and escaped my notice, and looking at the number of subscribers, has escaped everyone's notice.  I didn't expect Lilly to enter this space so early, given the fact that they still send out their press release updates by email and not RSS Feed like most large pharmaceutical companies.  (That is like using the U.S. Postal Service snail mail instead of email.)  But, what they have done is brilliant in notion, if not execution.

Lilly has started a disease-specific channel to appeal on diabetes called LillyDiabetes.  This is frankly a great idea and exactly the kind of thing I've been preaching here.  If you want to see them, go to LillyDiabetes, or join me on the Eye on FDA channel, where I've placed them into a special Diabetes Playlist.

But opening a channel is not enough.  The Lilly channel only has 3 subscribers, I became the 4th this morning, even though it has been open for 8 weeks.  I opened the Eye on FDA YouTube channel on Tuesday and have 16 and there have been 233 channel viewings and 133 video viewings.  By comparison, the LillyDiabetes channel has had only 43 viewings and 53 vids viewed. All I have so far done is mention the channel here and on my Twitter account.  But there is far more to effective promotion.

Bear in mind, YouTube is going to only grow further in its significance and influence and ability to reach disease-specific populations with key messages about prevention and treatment.  Right now, a pharma detractor or conspiracy theorist can post a video making outlandish claims about a product and get tens of thousands of hits in a week.  Pharma has to master this communications channel and promotion techniques as well.  Believe me, Twitter and YouTube are going to be key tools in future crisis communications efforts.  I already use them regularly in my own work in that space.   

If you are going to start a YouTube channel (and you should before your competitors do), simply opening it does not do enough to attract viewers.  That is like getting a cable channel and then not letting anyone know that it is there until they happened to channel hop onto it.  Here are just a few things you need to do:

• Issue an Web News Release (WNR) about the launch of the channel.  If you don't know what a WNR is, call me.
• Do some online editorial outreach (OEO) to key bloggers in this space to let them know of the launch and offer interviews with those behind it in print or podcast form regarding the launch, the objectives and the makeup of the channel.  If you don't know how to do OEO, call me.
• Get a linkage strategy going.  Consider creating a widget with a link to your channel for putting up on key sites - like Lilly should have a Diabetes Channel Widget made up that could go onto the sites of large diabetes organizations and places where people with diabetes or at risk go for information, that would link them to the vids.  If you don't know how to do a linkage strategy or make a widget, call me.
• Consider allowing partners to post their vids on your channel.  Are you going to be a C-Span, where you just show your own vids - or a Bravo - a channel that buys programming and puts it on their channel?  By combining partners, you combine appeal and following of others to your own cache.  Of Lilly's 28 vids, most  of them are vids produced by other sites.  Perhaps you lose control over message, but you allow consumers/patients choice and variety.   
• Put together an editorial calendar to let us know what's coming, kind of like a TV Guide, so we can look forward to it and promote it ahead of time.
• Mention the channel on your blog, if you have one, like Johnson & Johnson's blog - JNJBTW.
• Put it on your Web site (duh)  prominently.
• Open a Twitter account (see my paper on New Media and Public Affairs).  Twitter about your YouTube channel.  (My twitter account is followed by several media outlets and even some government outlets). 
• And oh, if you don't know how to set up an RSS Feed for your press releases - yes, call me!
• And oh yeah, send out a press release.

In other words, putting together a YouTube channel is not exactly a "if you build it they will come" proposition.  Get busy, you are all light years behind.   And if your MedReg folks are concerned, by all means CALL ME!  I have a whole slide show for them.