Sanofi announces FDA approval of Sklice for treating head lice

I’m not big on tooting my own horn. But I can’t pass up the opportunity to publicize something that has been this important a part of my professional life coming to fruition.

This morning, Sanofi announced that the FDA has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. The product will be commercialized by Sanofi Pasteur U.S., the vaccines division of Sanofi-Aventis Group. Last October, Sanofi-Pasteur acquired Topaz Pharmaceuticals, Inc., my former employer and the company that conducted Sklice’s R&D program, including all of its clinical trials.

I had the great privilege of working on this project for nearly two years. In addition to getting to work on a product that provides a novel method of treating a public health condition affecting millions of U.S. children each year, I got to work with terrific people who are some of the best around at what they do. I learned a lot from them and enjoyed working with them. Some of the people there spent nearly five years working to bring about this day – admittedly far less than the average time it takes to get a new drug through the entire R&D and FDA approval processes, but still a very long period of time. While larger pharmaceutical companies do this frequently, it’s quite a feat for a company that had 10 employees.

I’m very happy for them that they got to see this dream come to fruition.

You can read the entire press release here.

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FDA pharma social media ‘guidelines’ leave pharma wanting

While most of us (myself included) were preoccupied with our holiday celebrations, the FDA quietly released a Social Media guidance.

Sort of, anyway.

Ad Age‘s Rich Thomaselli reported last Friday that the FDA announced new Social Media marketing guidelines for pharmaceutical companies. But the document, titled “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” only covers the discussion of off-label information.

For that reason alone, it falls far short of what the pharmaceutical industry not only was looking for, but needs.

“What everybody was expecting was actual guidelines around social media,” Jim Dayton, senior director of emerging media for Overland Park, Kan.-based InTouch Solutions, a pharma-centric digital-marketing agency, told Ad Age.

“I still think it’s monumental,” he added. “The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn’t happen here.”

The document provides pharma companies with instructions for responding to consumers who use Social Media to ask about potential off-label uses for prescription drugs. A thorough, complete Social Media guidance – the kind the FDA held a public hearing more than two years ago to develop – would have been far more encompassing. Perhaps it’s no wonder then that the FDA released these guidelines during the Holidays (when they’re less likely to get noticed) and did so without even a press release.

“We understand the level of interest and wanted to get out what we had available to provide guidance,” FDA spokeswoman Karen Mahoney told Ad Age. She also added that this was just “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009.”

But when will those guidances come? And why does it have to be done piecemeal? This is all the FDA could get done in 2+ years?

 

What is to come in 2012?

It’s hard to believe, but another year is almost over. Christmas is only a few days a way, and a week after that, we’ll flip the calendar to 2012.

What will happen in the year to come in communication? In healthcare? In public relations? What new technology (or technologies) will emerge? Which existing technologies will be relegated to the dustbin of history, like coin-operated pay phones? What great advances will happen in healthcare and healthcare delivery? Which organization will build a strong foundation for years to come with strong, carefully planned and executed public relations efforts? Which organizations will be tarnished by bungling their public relations, particularly in a crisis situation?

We can ask those questions at this time every year. But here are some unique ones to think about as 2011 comes to a close:

1. Will Google+ seriously challenge Facebook? I was not impressed with it when I first got on, and I still use it only rarely. But it does appear to slowly be catching on. Will it become real competition for Facebook in 2012?

2. Will organizations reevaluate and improve their crisis communication plans? We saw the tattoo scandal at Ohio State and the horrible sexual molestation scandal at Penn State – they were just two examples this year of poor crisis PR. It’s an area to which many organizations do not devote sufficient resources or planning, and they can and have paid a huge price for that. Hopefully this year’s prominent crisis PR disasters taught them a lesson.

3. Will more pharmaceutical companies get serious about social media, even with no FDA guidance on the horizon? One of my favorite reads in the area of pharmaceutical marketing – Rich Meyer’s World of DTC Marketing blog – praised Sanofi’s “Why Insulin?” Social Media campaign as an example of how pharma companies can creatively and effectively use Social Media while not running afoul of the FDA. With no specific FDA guidance likely to come anytime soon, pharma companies can and should learn from Sanofi’s example. Will they? The cutbacks to marketing that many pharma companies made this year won’t help any.

4. Which Presidential candidate will do the best job crafting and selling his/her story? Next year will be a presidential election year (the Iowa Caucus is on Jan. 3!). Which candidate will put forth the best story? Which candidate will be the most effective at selling that story? And how much of an impact will the stories told by PACs and outside groups – who were greatly enabled by last year’s Citizens United ruling by the Supreme Court – have on the election? While I do find the partisan bickering in Washington to be tiresome, I do find campaigns themselves to be fascinating, and the upcoming election will definitely be fascinating, no matter which side you want to win.

That’s all for me in 2011. It’s been an interesting year for me in many ways – finishing my masters degree, helping build a start-up pharmaceutical company into a tangible product that could attract a merger with a major pharmaceutical company and now looking for the next opportunity.  I leave you with what, in my opinion, is an underrated holiday song from an underrated movie. Happy Holidays, and all the best for 2012.

Clinical trial sponsors, investigators must now account for social media in study designs

The Pink Sheet is a newsletter on the pharmaceutical industry read by many drug manufacturers. One recent issue had a report discussing the impact of Social Media, such as Facebook, on the design and execution of clinical trials.

You can read the whole story here: Social Networks in Clinical Trial Design

Clinical trials, in particular the all-important Phase 3 Pivotal trials, cost many millions of dollars to execute. They are designed meticulously, especially when it comes to blinding and randomization controls. Study subjects can’t know whether they took the study drug, the placebo (or, if applicable, the comparative drug) until after the trial is completed. If they did, they might not react naturally or adhere to the study protocol, and the trial results could be compromised.

Derrick Gingery reports:

Craig Lipset, Pfizer senior director in clinical research, said patients are using chat rooms and forums directed at specific diseases, in some cases talking about the clinical trials in which they are participating and their experiences with the study drugs. The online talk could threaten a trial’s blinding and randomization, especially as patients are more able to interact with other trial participants, he noted.

At the same time, as Lipset says later in the story, asking clinical trial subjects to refrain from using Social Media is not realistic. Recruiting subjects for clinical trials and getting them to follow existing protocols is hard enough as it is. So trial sponsors and investigators need to account for these tools in designing clinical trials.

Lipset’s employer, Pfizer, took a step in this direction this past June by conducting a virtual clinical trial for the long-acting formulation of Detrol LA. Other drug sponsors, investigators and CROs (contract research organizations) will likewise need to design clinical trials with Social Media in mind.

At the same time, researchers and pharmaceutical companies can also use Social Media to their advantage. While comments on a Facebook page or an internet message board are not statistically reliable or a substitute for the FDA’s adverse events reporting guidelines, they can provide hints of problems  before they become catastrophic public relations disasters. On a more positive note, sponsors can, as Gingery reports, tap into social media to recruit subjects for clinical trials.

 

Study: Pharma journal ads are often not FDA-compliant

The journal PLoS One released a study yesterday on the adherence of pharmaceutical advertising in medical journals to the FDA’s guidelines. And the findings suggest that there may be a problem with the FDA’s regulations regarding drug advertising.

According to the study, less than 20% of the advertisements studied were completely compliant with FDA regulations. In addition, nearly half of the 89 advertisements from November 2008 issues of leading U.S. biomedical journals were non-compliant with at least one of the FDA’s descriptions of bias and a third were found to be possibly non-compliant due to incomplete information.

The full report on the study is available here.

I admit that 89 advertisements isn’t a very large sample size. And determining whether something is FDA-compliant or not is a somewhat subjective process. But these figures suggest that the FDA may need to make its regulations of drug advertising simpler and easier to understand.

The large pharmaceutical companies have staffs dedicated to ensuring compliance with the regulations put forth and enforced by DDMAC, the FDA sub-agency that governs this area. Even the smaller companies take great care to stay in compliance. They thoroughly vet all advertising and other promotional materials. Then they vet them again, and even more times still, before they go out in the public domain. With fines of hundreds of thousands, if not millions, of dollars on the line, you don’t want to mess around with this.

Yet in spite of all that, a sizable majority of ads appear to be non-compliant. And this makes me wonder if the FDA should make its regulations clearer and more concise. I’m all for the FDA requiring drug ads to be responsible, accurate, truthful and fair and balanced. But all the regulations in the world do no good if companies can’t comply with them.

I believe that content should have what I call “the 4 Cs:” it should be clear, compelling, complete and concise. No one expects government regulations to be compelling (that’s not what regulation is for after all!). But it would only help drug manufacturers and marketers if those regulations were clear, complete and concise. Regulate what needs to be regulated, but make the regulations as clear and simple as possible.

Pharma Facebook Pages: Did Facebook kill the Social Media star?

OK, I know that headline was a bad 80’s music pun. But John “Pharmaguy” Mack, author of the Pharma Marketing Blog, raises another great point in his post on Wednesday when he notes the timing of Facebook opening up commenting on Facebook fan pages (effective August 15) and two large pharma companies moving to shut down Facebook communities.

First, a little context here: the pharmaceutical industry has been waiting for almost two years for the FDA to issue a guidance on the use of Social Media in the industry. Yet that guidance has not come and, as I noted here months ago, isn’t expected to come until 2013, if then. So pharmaceutical companies have slowly begun dipping their toes into the water, understandably moving very carefully due to their uncertainty over how the FDA’s extensive and complicated drug advertising and marketing rules apply to these new communication tools.

One aspect of Social Media that they have great concern about is user commenting. The FDA has very specific rules regarding the reporting of adverse events, and those rules don’t include posting those tales in a public forum like a Facebook fan page. In addition, like any business, pharmaceutical companies are very protective of their reputation and don’t want one nasty, ill-informed comment to jeopardize a product that they have spent hundreds of million dollars and many years researching, developing, testing and bringing through the FDA’s new drug approval process. So they moderate user comments carefully in the Facebook communities that they set up.

Now that Facebook is opening up user commenting on Facebook pages, several pharmaceutical companies are getting cold feet about engaging patients (ie, their customers) in this space. As Mack notes, Jannsen Pharmaceuticals is shutting down its ADHD Moms community, abandoning almost 24,000 followers. And Sanofi-Aventis is shutting down its “Voices” page, redirecting patients to its Sanofi US page.

Are these companies being prudent in response to Facebook’s changes? Are they overreacting? Or, as Mack suggests at the end of his piece, is this just a cover story for other reasons to shut down these communities?

Pfizer’s “virtual” clinical trial intrigues, but leaves lots of questions

Clinical trials are the backbone of the new drug development process. Without them, you can’t get FDA approval to market your drug. Pharmaceutical companies spend millions, of dollars designing, recruiting for and executing even a single clinical trial, and you need at least three, if not more, to get approval.

Recruiting for clinical trials is challenging. Getting enough patients to completely adhere to the clinical trial’s protocol to have a sufficient data pool may be even more challenging. All of this makes Pfizer’s starting of the first “virtual” clinical trial in the United States an intriguing story, although one that still leaves questions to be answered.

Instead of residing in or regularly visiting a research facility for the entire length of the trial, patients would administer the study drug (Detrol LA, Pfizer’s long-acting formulation of its overactive bladder treatment), as well as monitor and report the necessary vital signs and results, on their own. Pfizer’s project, which goes by the acronym “REMOTE,” is aimed at expanding access to clinical trials, and therefore diversifying the pool of participants, which currently is limited to whoever happens to live near the participating research facilities.

It’s a very interesting idea. And if it works, it could have some very positive results. In addition to improving access to clinical trials, it could save trial sponsors money by not having to compensate participants to repeatedly travel to the research facility.

But there are some very important questions that need to be answered:

  • How many drugs will this type of clinical trial be able to be used for? I imagine that drugs that need to be administered by a medical professional (such as intravenous chemotherapy drugs for cancer) won’t work for virtual clinical trials.
  • How do you go about training participants to correctly monitor and obtain the required data on their own?
  • Do they need to use exactly the same equipment to monitor and obtain vitals?
  • How do you protect the blinding and the confidentiality of the patient data when conducting a trial virtually? Blinding is vital to clinical trials. And patient data must be kept confidential to comply with HIPAA and FDA policy.
  • Would a virtual clinical trial shut out demographic groups that don’t have easy access to the necessary technology? How would this affect the reliability of the data?

I’ll be very interested to see how this project turns out. It could present a major revolution in the pharmaceutical research and development process. Or it could be yet another idea that sounds good in theory but doesn’t work in reality. We’ll see what happens.

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