Weekly Roundup 7.22.16

Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I may cover this week, came from last, but was really interesting and so we are including it here. I am liable to be just as dull in August.

That said, there were some things of note:

  • Advisory Committee Recommendations and the Psoriasis Landscape – Two different AdComms were held that were of note. In meetings of the Arthritis Drugs Advisory Committee on the 12th and 13th, it was recommended that two new biosimilars be recommended for approval for several indications held by the reference products.  If these are both approved by FDA it would double the number of FDA approved biosimilars. Both applications sought approval of multiple indications, one of which included treatment for moderate to severe plaque psoriasis and both had unanimous approval of the committee.  And in a related development, another biologic that sought approval for the treatment of moderate to severe plaque psoriasis received a recommendation of approval during a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee on June 19, also with unanimous approval.
  • Advisory Committee Calendar Light on NDA Deliberations – On a related note, right now the FDA calendar of upcoming advisory committee meetings has six scheduled during the balance of July through October, but only one of these is to consider a new product for market. As noted in a recent posting about FDA press releases, fewer approvals have been announced by FDA this year compared to last year’s banner year of approvals. Not every drug has an advisory committee hearing, but it nevertheless is one of the indicators about the approval rate moving forward. It could certainly change in the remainder of this year, but the limited and early indications are that this year may not meet the level of last year’s approvals.
  • HIV Developments – The International AIDS Conference was held this week in Durban, South Africa. It is the second time the conference has been held there and the first time was not long after the introduction of anti-retroviral therapy (ART). At that time, the challenge was to get people treatment with ART as a means to save their lives – a goal that is still a work in progress. Since then the role of treatment as a prevention has emerged with important data published in the New England Journal of Medicine - Antiretroviral Therapy for the Prevention of HIV-1 Transmission. On a related note, NIH announced this week that it was expanding investment into basic medical research aimed at a cure for HIV.

Stay as cool as you can this weekend and take care.

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More or Less – A Look at FDA Press Releases at Half Year

What do FDA press releases for the year say about the rate of new approvals for 2016?

Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I provided an overview of the first quarter look at the press releases sent out by FDA. What we saw then was announcements of approvals – both for devices and drugs – were down from the previous year. As we cross the mid-year mark, it is time to update and see where we are in terms of FDA pronouncements.

It is important to note here that official announcements of FDA approval actions are just that – not every approval gets a press release. By my observation, they are generally focused primarily on matters that are noteworthy because they are just that – and this year have included a number of compounds that have had one or more of the following – breakthrough therapy designation, priority review status, accelerated approval and/or orphan drug status. You don’t usually see releases for drugs that are fifth in class, unless they bring something new to the table.

Here is an overview of letters comparing the first six months of approvals for the years 2013-2016.

The purple line at the top shows us the total number of press releases for the first half-year period of each year from 2013-2016. One can see that while there were more in 2013, the past few years appear relatively even, though slightly under the past few years.

However, when looking at the green line which denotes combined approval announcements (drugs, devices, and other -which includes tobacco, apps, food-related approvals), at 32 total approvals (drug, device and one in food) the number for the first half of this year was down quite a bit from last year, when FDA had a banner year of approvals of new molecular entities.

Both drugs (signified by the red line) and devices (signified by the blue line) are down, however, the drug approvals experienced a greater drop than did devices. By mid-year last year there were 28 new drug approvals compared to 19 so far in 2016. That said, when you look back to last year’s banner year of approvals, the bulk of the new drug approval announcements occurred in the second half of the year (47).

The other categories tracked – legal actions such as consent decrees, recalls and public health alerts and general announcements were all at similar levels to years gone by , though the issuance of new policy through rules is higher, with 14 issued so far this year, compared to only 7 at this time last year.

Again, approval announcements are not the same as approvals – many approvals have no FDA announcement. But using the press releases as an indicator of the current approval rate of new molecular entities, unless the second half of this year follows the same pattern as last year, there may be indications that 2016 is not the banner year in approvals that marked 2015.

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Weekly Roundup 7.8.16

Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer is well along when in my  mind, the buds have just pushed and daffodils were in bloom. July 4th came and went already when it seems like we just had Memorial Day. Before you know it, we will be back to school.

You may still be away from the long Fourth of July weekend or enjoying a shorter work week if you are back. Just prior, a lot happened last week and some this and since there was no Weekly Roundup last week, we are coving two weeks.  Here is some of what I found interesting:

  • FDA Launches Oncology Center of Excellence – Both public and private institutions are in the process of responding to President Obama’s “Cancer Moonshot” announced in this year’s State of the Union message and headed by Vice President Biden. The gist of the effort is to better coordinate resources focused on cancer treatment and research to effect outcomes more quickly by concentrating efforts across the board. As part of its response this week FDA named Dr. Richard Pazdur as the Acting Head of FDA’s Oncology Center of Excellence (OCE). According to the agency release, Dr. Pazdur will be working to bring closer collaboration across the FDA centers (devices, biologics, drugs) to develop greater coordination and review of new advances. In his blog posting on the topic, Dr. Pazdur also stressed that the effort will also engage outside FDA as well, ensuring that patients have a voice. Many aspects of Dr. Pazdur’s professional experience and personal life went into the choice. While often FDA communications are in FDA-speak, you can read a very nice 2016 New York Times article about him here.
  • FDA Chips in to Move the Needle in Precision Medicine - In his 2015 State of the Union message President Obama launched the Precision Medicine Initiative aimed at speeding up the process by which we would be able to deliver therapies for patients that are determined to be the right ones rather than treatment by trial and error. Fundamental to success in that goal is the development of genetic testing. There are many moving parts, but this week FDA added a contribution with the announcement that the agency was issuing two guidance documents to provide a “streamlined approach” for oversight of genetic testing. According to FDA’s release, new sequencing technologies will allow for the examination of millions of DNA variants at a time, rather than taking a more piecemeal approach.  NIH urged researchers to adopt the best practices outlined in the draft guidance documents which the release states were developed to enhance test development while maintaining safety. The two draft guidance documents can be found here and here.
  • Zika, NIH and the Olympics – A lot is being written, and a lot more is likely to be written, about Zika and the upcoming Olympics in Brazil. This week NIH announced that it was funding a Zika study of the U.S. Olympic team to monitor potential infections among them. The stated goal of the study is to better understand how the virus persists in the human body as well as to identify personal factors that may influence the course of the infection. In another Zika development, FDA announced an Emergency Use Authorization for an In Vitro diagnostic device for use in the detection of Zika virus.

There is more of interest, but that’s it for me this week folks. Next week I will provide you with an update on what FDA had to say during the first half of 2016 and how it compares to other years. Until then, have a good weekend!

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Pharma Twitter Activity

I recall a time when the head of a regulatory department of a pharmaceutical company told me that the company would never, ever, ever under any circumstances be involved in social media. By my count, today that company has twenty-one different twitter feeds running, nine of them in the U.S. and the rest around the world. It is not an atypical history when it comes to pharma and social media. In the beginning there were few. Today there are many.

For some time now, I have monitored the activity of pharma across several social media platforms in a database that tracks what companies are doing on Twitter, Facebook, YouTube, Pinterest, Google+ and Periscope. An activity gets logged and characterized as I become aware of it and during regular concerted efforts to discover activity and log it in. Therefore the database where I store this information is not perfect, and has some rough edges – the numbers should not be construed as absolute, but they do serve as a healthy observation and characterization of activity where we can sort by company, country, frequency of updates, and purpose for which the activity is undertaken.

Recently I worked to update the Twitter feeds and added in about 40 of which I had not been aware. Nearly all of them are listed here on my Twitter list of pharmas.

  • How many? Looking first to numbers – the numbers have grown even if the strategy may not seem all that apparent. The total number of Twitter feeds in the data base is 335 being run by 69 companies making prescription products – removing those that are aimed at supporting over-the-counter products. Obviously there are some pharma company brands that run multiple feeds. Some run over 20.
  • How busy? One of the fields tracked is how often the feed is used and only 201 had “regular” or “daily” updates with another 8 having rare updates. The balance were inactive/dormant accounts. (See posting “Abandoned Properties“) Of the active feeds, the pharmas are following about 190,000 others and being followed by 2.7 million, though it should be noted that this census represents numbers from last summer as those numbers are only recorded once a year.
  • What for? The feeds in the data base are characterized by primary purpose. Of the active 201 – what is the activity?  Overwhelmingly the purpose is a corporate one with 141 of the Twitter feeds serving some direct corporate purpose, including corporate social responsibility (CSR) – of which 9 appear directly related to CSR and about another half dozen could be characterized as being involved in advocacy. There are also a fairly large number that have been devoted to the issue of a disease or condition (39 overall, 23 among the active). A few are even dealing in product-specific work to varying degrees. Finally, there are a number of Twitter feeds devoted to recruitment. Looking for a job?  There are 36 such feeds and you can see just those recruiting tweets here.
  • Where are they? What may surprise some is that 58 percent of the active Twitter feeds were outside of the United States. That appears largely because many of the multinational firms have developed feeds that are country and language specific.

The FDA guidance and/or lack thereof and the FDA OPDP enforcement and/or lack thereof, may have chilled entry into the Twittersphere by many, but that has not lasted. The numbers have increased, but industry may be a ways off from finding its stride here entirely, But Twitter is a news platform see my updated list of Healthcare reporters on twitter) –  it reports news and drives traffic. While many companies are still not there, others realize that engagement here is important. In short, pharma has emerged on Twitter in healthy numbers. In the next phase, many companies will likely be working to more closely coordinate their efforts while others may still contemplate whether to take the plunge.

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Weekly Roundup 6.17.16

We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy:

  • Tragedy in Orlando and FDA Blood Policy – In the wake of the Orlando tragedy that so heavily involved the LGBTQ community, most members of the community were barred by FDA policy from donating needed blood to help treat survivors. In a guidance document issued last year, FDA had revised its extreme policy of defacto deferral of all donations from gay men to one that deferred donations from gay men who had had sex within the past year. (See “The Guidance that Dare Not Speak its Name“).  Other countries have followed suit. The tragedy drew scrutiny on the latest deferral policy raising question as to whether or not the new construct was in fact justified. From an issues management perspective as well as a policy perspective, FDA would do well to convene another public forum on the matter and cast the net widely for input.
  • FDA Approves Cholera Vaccine - This week FDA announced approval of a new vaccine to protect against cholera. Called Vaxchora, it had fast track designation and priority review status and is the first such FDA approved vaccine. While the FDA release states that the vaccine is intended for travelers, in fact cholera can occur in settings where there has been a breakdown in sanitation, such as in the wake of a natural disaster.
  • Device to Treat Obesity Approved – A tube that is surgically inserted into the patient that drains a portion of stomach contents after every meal was approved this week by FDA.  The approval is meant to provide another device/surgical alternative for patients who do not respond to non-surgical means of weight loss and the release states that it is intended for use in adults with a body mass index between 35 and 55 over the age of 22 years. According to the FDA, the device will allow patients to remove approximately thirty percent of the calories that were consumed during the meal when used 20-30 minutes afterwards.

That’s all for me this week. I had intended to have a posting with an update on pharma and twitter use, but it is now scheduled for next week. Until then, be well and be safe.

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