Upward Mobility – The Great Migration Into Optimizing

One of the many noteworthy milestones with respect to digital has been around the transition to mobile search. As was recently reported, Google’s Amit Singhal speaking at a conference noted that Google is getting over 100 billion searches each month and that over half of them are taking place on screens that are less than six inches on mobile devices. Despite that, as noted here, there is no guidance from FDA about how pharma companies should design a branded site for mobile.

This past Spring, I did a few posts around mobile. In a June posting Regulatory Considerations for Optimizing a Site for Mobile” I took a quick look at 10 brand name drug sites and found that only 5 were optimized for mobile. That has changed.

In December 2013, I wrote a posting that also looked at medical societies and optimization for mobile – “Optimizing for Mobile – Do It!”  At that time a quick survey of 10 top medical societies found that only 4 had optimized for mobile despite the fact that when you attend a medical meeting you have to jump out of the way of people who are walking while looking at a hand held or tablet. That same posting noted that a Manhattan Research report had indicated that only a third of pharma sites were optimized for mobile. That too has changed.

This is not a scientific survey, but I took a look at the sites for pharma companies, drug brands and medical societies and found that while mobilization is still not universal, it is on the up. Not going to name names here:

  • A look at 16 top pharmaceutical companies found 11 had sites that were friendly to a phone search, 5 did not;
  • A look at 19 brand sites found that 15 were optimized for mobile and only 4 were not;
  • Examining 13 sites of large medical societies found that only 1 was not optimized for mobile

Given that seeking health information is a primary use of the Internet and given that more searches are happening on mobile devices, it would make sense that optimization is on an upward trajectory, but it still may be surprising that it is not universal. After all, even www.fda.gov is now optimized for mobile (so is NIH).

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Weekly Roundup 10.30.15

If you are like me, you have raided – at least once – the stash of candy you have squirreled away to give out this weekend. It happens every year. I am weak. Fortunately, tomorrow they will arrive and take the tempting morsels away.

I had intended on some postings this week between the Weekly Roundup, but time simply did not permit. I will try harder next week. In the meantime, here is a bit of what happened.

  • Novel New Approval in Melanoma – It was announced this week that FDA had approved Imlygic™ (talimogene laherparepvec) for the treatment of melanoma lesions in the skin and lymph nodes which cannot be removed completely with surgery. The treatment is the first FDA-approved oncolytic virus therapy. The therapy is injected directly into melanoma lesions where it replicates inside cancer cells and causes their death. The company noted in its press release that the therapy has not been shown to improve overall survival or have an effect on visceral metastases.
  • Second Melanoma Development - In addition to the above novel treatment, FDA also announced the expanded approval of Yervoy (ipilimumab) for its inclusion as an adjuvant therapy for patients with stage III melanoma to lower the risk of recurrence of the condition following surgery. Yervoy, a monoclonal antibody, was originally approved in 2011 to treat late-stage melanoma. Yervoy blocks a particular molecule that may play a role in slowing down the body’s immune system and therefore affecting the ability to fight off cancerous cells. In clinical studies, 49 percent of participants who were administered Yervoy saw their cancer return after an average of 26 months compared to 62 percent of those who received placebo who saw their cancer return on average in seventeen months. The label includes a Boxed Warning and it will be accompanied by a Medication Guide. The company press release can be seen here.
  • Polling Public Outlook on FDA Review of Drug Ads - This week the Kaiser Family Foundation released a poll on a number of aspects of prescription drugs – involving issues ranging from pricing to advertising. On the latter, the poll found that a majority of people – in fact 90 percent – felt that FDA should review prescription drug ads before they air. According to the KHN story (“Majority of American Agree That The FDA Should Review Drug Ads Before They Air“, by Shefali Luthra, October 28, 2015). The piece has some very interesting data on how many viewers of such ads then act on the information to talk to their doctor and the results of that interaction.

That’s it for me this week folks. Have a fun and safe Halloween and enjoy the weekend.

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Weekly Roundup 10.23.15

There was no Weekly Roundup last week due to a confluence of circumstances, including the fact that it seemed a very quiet week last week when it comes to many of the things I watch. But this week, there was quite a bit of activity and a lot of it was good stuff – and so here it is:

  • FDA Approves Anticoagulant Reversal Agent – The agency announced that accelerated approval was granted to Praxbind (idarucizumab) for use in patients who are taking anticoagulant Pradaxa (dabigatan) during emergency situations where there is a need to reverse the blood-thinning effects of the treatment. FDA noted that while the treatment with Pradaxa is life-saving for some patients, reversal is sometimes medically necessary. Need a refresher on the difference between Accelerated Approval, Fast Track, Breakthrough Therapy and Priority Review? FDA provides it here.
  • Approval of Pancreatic Cancer Treatment - A new approval in an area with limited current options – FDA announced approval Onivyde (irinotecan lipsome injection) in combination with fluorouracil and leucovorin to treat patients with advanced pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency stated that in clinical trials, the patients receiving Onivude plus fluorouracil/leucovorin had a delay in average amount of time to tumor growth of 3.1 months compared to 1.5 months for those receiving flueoouracil/leucovorin. The National Cancer Institute estimates that there will be nearly 50,000 pancreatic cancer cases diagnosed in the U.S. in 2015. Onivyde had Priority Review and orphan drug designations. You can check out  the multimedia press release from the company Merrimack here.
  • New Treatment Approved for Potassium Buildup – Hyperkalemia – a condition in which the amount of potassium in the blood is high leading to dangerous and even fatal changes in heart rhythm, has a new treatment available with the FDA approval of Veltassa (patiromer for oral suspension). The buildup of potassium can occur when the kidneys are not able to remove enough potassium from the body. The new medication works by binding potassium in the gastrointestinal tract thereby decreasing its absorption. It will carry a boxed warning because it also can bind to other orally administered drugs and will also have a Medication Guide. The company’s press release can be found here.
  • FDA Seeks Consumer Reps for AdComms – Last week Eye on FDA carried a posting about the vacancy rates on AdComms (and the inconsistent way FDA tracks and reports them) and this week the agency is seeking to fill them – at least some of them. The FDA blog FDAVoice carried an appeal for those who might be interested. Having set through scores of AdComms in my time, I can assure you that the voice of the consumer representative is an important one bringing some real world perspective to the proceedings that is often needed. Reps are often from consumer/patient organizations, but they don’t have to be. The posting on the FDA blog carries a list of the current vacancies as well as links to the application process.

Photo courtesy of Anne Becker

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A Look Back at Regulatory Enforcement by Therapeutic Category

In past years, I have always provided quarterly updates of the Warning and Untitled Letters that the Office of Prescription Drug Promotion (formerly DDMAC) puts out, regulating the promotion of pharmaceutical products. However, with only one letter issued each month so far this year through August – and none posted for September or October, enforcement appears at a near standstill. It seemed like a good time to look back at past letters in the aggregate for some insights.

Keeping all of the letters in a database that is regularly updated allows me to sort on a number of fields. Fields tracked include the type of communications vehicle (digital or non-digital), the specific communications vehicle (brochure, website) and pertinent to this posting, the treatment area for the indication, among other things. This accumulation not only provides perspective – but it also a great source to use as a training tool.

The Warning/Untitled letter database spans back through 2004 (inclusive) and covers the contents of 307 letters which address communications carried by pharma companies in over 400 different communications vehicles (sometimes a letter will address violations across more than one communications vehicle produced by a company). The total number of violations over that period of time is nearly 1100.

I thought that a good place to start in a retrospective might be whether or not therapeutic categories stand out in any way from one another.

And the answer is yes. If for no other reason than by volume.

Treatment areas are broadly categorized as follows:

  • Antiviral/Antimicrobial
  • CKD/Renal
  • CNS
  • Cardiovascular
  • Dermatologic
  • Endo/Metabolic
  • Gastrointestinal
  • Imaging Agents
  • Oncology
  • Ophthalmic
  • Pain
  • Pulmonary
  • Reproductive
  • Urologic
  • Other

As you can see CNS is a big category involving the treatment of a broad spectrum of conditions, including depression, Alzheimer’s, schizophrenia, bipolar, ADHD, smoking cessation products and others. While CNS would normally include Pain – Pain is such a large sub-category that it is backed out and made its own for these purposes. Oncology spanned all types of cancers. Cardiovascular included treatments for hypertension, cholesterol, blood thinners and related conditions. And AntiInfective includes antivirals such as HIV medications, hepatitis and herpes as well as antibiotics and antifungals. (Note sub-categories can also be sorted so that one can look only at HIV-related issues.)

Looking back to all the letters over the years, what we see is that those drugs in the CNS area garnered by far the most letters (58), probably mainly due to the fact that the category is so broad and varied in terms of products (not implying that CNS is a riskier area – the numbers alone don’t tell that story).

It was also interesting that the pain category, while fourth in total letter volume overall, had a very large proportion of its letters coming in the form of a Warning Letter (represented in red), as did Dermatology. This perhaps indicates that when it comes to the these particular categories there may be an argument for taking extra care in devising communications – or at least being highly conversant with the circumstances by which other pain and derma meds have received letters. By contrast, the lowest proportion of Warning Letters went to Endocrinologic (which includes diabetes, osteoporisis) were only 2 out of 11 letters were Warning Letters.

On average, the percentage of violations overall cited in Warning Letters across all treatment areas was about 25 percent). The treatment areas that had proportions of Warning Letters higher than that included Anti-Infective, Cardiovascular, Dermatological (nearly half!), Gastrointestinal, Pain and Pulmonary. Surprisingly, CNS – with its many black box warning labels – and Oncology were below the average.

The real value comes in characterizing the reasons for violations in these categories. But it is clear, not all therapeutic categories are equal.

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Advisory Committee – Vacancies and Transparencies

The FDA has a total of 33 Advisory Committees, 17 of which are focused on Drugs and 5 of which are focused on blood, vaccines and other biologics. For our purposes today, we are going to focus on those dedicated to drugs – see how well we are doing on keeping track of vacancies (remember, FDA is almost always looking for people to serve on an AdComm) and on transparency – specifically the ability to understand the range of expertise on the committee by knowing the background of the members.

Vacancies. Recruiting qualified experts to serve on advisory committees who do not have conflicts of interest has got to be one monumental job. As such, there are frequently vacancies and in fact, there have been times in the past where a committee could have more vacancies than members.

By last count per the FDA Track dashboard, there was a 13 percent vacancy rate (the goal is 10 percent) as of March 2015 (the date it was last updated) – and it has generally hovered around that number for many months.

Vacancies are important for a couple of reasons – first there may be good candidates for filling the vacancies and second because companies that will have drugs up for consideration before the committees generally like to know the makeup of the committee before a meeting. While there can always be added consultants to a committee meeting, having too many vacancies introduces a wild card element to the proceeding.

Here is a list of the committees that have current vacancies.  Unfortunately, you will see two sets of numbers. The first number is the number of vacancies that are listed on the individual roster of each of the Advisory Committees, which you can see by clicking on the individual link/while the second number is the number of vacancies listed on the page FDA maintains to overview vacancies on the advisory committees. It is also interesting to note that while the roster page for the Non-Prescription Drugs Advisory Committee states that there are zero vacancies, where the name of the Chairperson should be is the word “Vacant” – so the body of the roster differs from the heading of the roster.

As you will see, there is frequent disagreement between the two sources of advisory committee information on vacancies making it uncertain as to exactly how many vacancies exist at present :

In the end, determining the vacancies on committees appears to depend where you go for the information on the FDA site.

Transparency. The rosters for each of the AdComms not only provides us with the list of who is (and who is not) on the committee, but it also contains links to the curriculum vitae of each member. Usually.

For the sake not only of transparency and assessment of conflict of interest, but also again because companies should know the makeup and background of the committee before whom they are going to appear, the information should be readily available to the public. In the distant past, there were high numbers of members who did not have such links, sometimes comprising half of a committee. The numbers are much better, but the links are still not universal. Here is where there are deficits:

  • Cardiovascular and Renal AdComm – 3 unlinked members
  • Dermatologic AdComm – 2 unlinked members
  • Drug Safety and Risk Management – 3 unlinked members
  • Oncologic Drugs AdComm – 2 unlinked members
  • Pharmaceutical Science AdComm - 3 unlinked members
  • Psychopharmacologic AdComm – 1 unlinked member

As far as providing transparency – FDA is doing a much improved job over the past, but still has some work to do.

Keeping up the FDA website has to be a great big job to coordinate – there are so many moving parts. And these may seem like a few small issues, but for the sake of accuracy, credibility and transparency when it comes to the drug approval and monitoring process, they are worth noting and worth fixing.

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