Weekly Roundup 3.28.14

You know I’m busy when I don’t even have time for the Weekly Roundup.  I have had a very heavy travel schedule and a workload that has been quite a heavy one.  And sadly, there is no letup in sight for the next few weeks.  On the bright side, we seem to be past the weekly snowstorm conditions, at least here in the Mid-Atlantic states.

Fortunately this seems to coincide with the fact that FDA is running at a particularly slow pace.  The Office of Prescription Drug Promotion (OPDP) has managed to only eek out 2 letters so far this year.  There hasn’t been a press release all week until today, and there have not been any interesting speeches or testimonies submitted for quite a while.  So while I’ve been distracted, it has come perhaps at a good time.  I will be including some of the events from the week prior given that last week, I missed the Weekly Roundup.

  • New Hemophilia B Agent with Less Frequent DosingFDA today approved the first long-acting recombinant coagulation Factor IX for use in adult Hemophilia B patients.  The product, Alprolix, was approved to help control bleeding episodes and as a prophylaxis to prevent them.  Alprolix is another in what has been a long line of orphan drug approvals recently by FDA, with Hemophilia B affecting approximately 3300 patients in the U.S.
  • Migraine Prevention Drug for Adolescents - Also today, the agency announced approval of a drug for use in the prevention of migraines in adolescents called Topamax.  First approved in 1996 to prevent seizures and then approved in 2004 for prevention of migraines in adults, it is now being authorized for adolescents.  The product will come with a MedGuide.
  • Approval for Patients with Psoriatic Arthritis - From last week, a new treatment option was approved for patients with psoriasis who develop arthritis. Treatment options until now included corticosteroids, TNF blockers and an interleukin inhibitor.  Otzela is an inhibitor of phosphodieasterase-4 (PDE-4). The release advises that patients who are on the treatment should be monitored for weight loss during use.

That’s it for me.  Hopefully soon I will have more time.

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Weekly Roundup 3.14.14

The nation is on the lookout for Spring.  And so am I.

Despite the harsh, harsh and cold winds of this week, and the redundant snowfall last week, there nevertheless appear daffodil buds above the dirt, some quite robust in appearance, as if emboldened by the lack of warm days.  They seem to cope better than I.

I have been distracted from reporting by a heavy travel and work schedule, but also FDA itself seems to be somewhat quiet.  Until the 11th, there had not been a press release since February 27 and there have been only two letters issued by the Office of Prescription Drug Promotion (OPDP) all year.  Perhaps the cold is bothering them as well.

Here is a bit of what caught my eye.

  • Pew Creates Excellent World Wide Web Timeline – That never-ending font of all things good related to knowledge and research involving the Internet – the Pew Internet Research Project – put together a most excellent timeline to mark the 25 year anniversary of the World Wide Web.  The web, which involved a whole bunch of information made foundable by the development of search and about which we wanted to talk about in via our new interconnectedness that began with email and instant messaging and went on to all forms of social media, bears some remarkable milestones, many of which were relatively recent.  A few of my favorites – 1990 – 42% of American adults have used a computer; 1996 – 77% of online users send or receive an email every few weeks; 1997 – Google registers as a domain… and there are many more gems.  Check it out here.
  • Migraine Device Approved – If you saw this, you might have been confused like I was at first.  On March 11, FDA issued a press release entitled “FDA Allows Marketing of First Medical Device to Prevent Migraine Headaches“.  Why confused?  Because it said “First” and yet I had a tremendous sense of having seen this before.  So, I consulted my new, handy, dandy data base that I made of FDA press releases and did a sort on “Approvals, Devices and Migraine” and there it was from December 2013 – “FDA Allows Marketing of First Device to Relieve Migraine Headache Pain“.  And so, mystery solved – the most recent was to prevent migraines and the earlier was to relieve.  Two different devices, two different companies, one prevent and one relieve.  One interesting thing of note here – the December 2013 announcement on the device to relieve migraine pain was also released in Spanish.  The 2014 announcement about the device to prevent migraines was only released in English.  It is a challenge to those of us trying to discern the pattern here.

That’s it for me this week.  I hope everyone has a great and trending warmer weekend.

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OPDP Issues Untitled Letter Involving Social Media

Sort of.

There is, of course, a difference between a regulatory action letter that is issued because of a social media use and a regulatory action letter that is issued the communication happens to involve a social media platform.  In the former, there is something about the unique aspect of the social media platform chosen that has caused there to be a violation. That was the case in 2010 when FDA issued a letter regarding the use of a Facebook share widget that did not convey the risk information with it.  The latter, however, involves the use of a social media platform to convey a communication that would have been a violation if it had been via social media or if it had been written on a piece of paper in a brochure.

This week FDA’s OPDP issued only the second violation letter of the year.  It was an untitled letter to a company because of the use of its Facebook page. It was not the fact that Facebook was being used, but rather the fact that there was a statement on the page that advised the reader  - if you had been diagnosed with the condition for which the drug was indicated, you should talk to your doctor about a prescription.  The mention of the indication and the drug, which has a boxed warning on the label, included no risk information about the drug.

In addition, the Facebook page failed to mention some of the limitations of the use of the drug – the boundaries of its indication.  For these reasons – failure to include risk information and omission of material facts, FDA stated that the page was violative.  FDA directed that the company cease the violation.  A response could be amending the page with the edifying information or taking the page down.  Following the link provided in the letter to the Facebook page, apparently the page was taken down.  FDA, however, provided a shot of the Facebook page with the material on it here.

It is worth noting because there is sometimes a hypersensitivity to risk involving social media that leads some to believe that any use of social media is inherently risky.  But in this case, the medium did not provide the risk.   It is not unlike videos that have been cited in violations on YouTube where risk information was not conveyed.  Like them, it was the classic case where – as FDA stated in the podcast here on Eye on FDA in April 2009 – it was the message, not the medium.

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Weekly Roundup 2.28.14

Last weekend was so warm I got to take my first bike ride and went around the Mall. It was delightful with temps in the 60′s.  Early in the week, I was excited to find a blooming crocus where just a few days before, there had been a huge drift of snow.  There it was on my dog walk, blooming purple against dark earth.

Later in the week I took the same picture.  Here it is.

This weekend is slated to be in the teens.  Definitely no bike ride.

But on the chance that you are more interested in FDA-related stuff, here is some of what happened this week that was notable:

  • Proposal for New Food Labels – FDA announced that it was proposing changes to food labeling that would reflect current nutritional science to help consumers make more informed choices.  The proposed changes to the label include formatting changes that emphasize some aspects of the same information that was included on the earlier version such as number of calories and the serving size.  The proposed new version also seeks to add new information not present before, such as including the amount of “added sugars” .  The release has links to a wealth of information about the new proposed label.

  • New Hispanic Health Data – Ok, it is not FDA, but it is significant – NIH released comprehensive data on Hispanic/Latino health and habits derived from a study that enrolled over 16,000 adults in geographically diverse cities around the U.S. and who had origins that included Central America, Cuba, Dominican Republic, Mexico, Puerto Rico and South America.  The study contains a good deal of information and some of it that was highlighted in the press release included the percentage of people who reported having asthma ranged from 7.4 among those of Mexican ancestry to 35.8 among those of Puerto Rican ancestry.  You can see the full data book here.
  • Another Approval for a Rare Condition - FDA seems to be on a roll when it comes to approving drugs intended to treat conditions that are rare.  This week it was a drug called Myalept marketed by Amylin Pharmaceuticals intended to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized, or acquired generalized lipodystrophy – a condition associated with a deficit of fat tissue.  According to the press release from FDA, the product has a REMS program that will require prescribers to enroll and certified after completing training.  By my count, that appears to be the fifth approval for a rare condition this year.
  • First Stop Sale Order for Tobacco Products – While tobacco products used to come on and off the market without oversight, under the authority of the Tobacco Control Act, FDA now as the authority to review products and determine which may be sold on the market by determining if market entries are substantially equivalent to a valid predicate product.  According to the press release, FDA identified four products for removal from the market.

That’s it for me this week.  A little more than one more week until Daylight Savings!

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FDA Press Releases – What They Say

Keeping my eye on FDA, and being most interested in communications, AND having a penchant for looking at patterns through databases, I started categorizing FDA press releases to see what they talked about and in what way.  I only started as of January 1, 2013 and tracked them by category.  What was the subject matter – an approval? A legal action? Rule making? Then I looked at what sector was affected – Drug, Device, Food/Beverage?  Some of the releases are in Spanish, so we tracked that too. Lastly we tracked the product area/use/indication affected and the product name, if there was one involved. In this way, I can look solely at approvals, or approvals in a particular treatment area.

A little of what i found. I counted 165 press releases for 2013 with 49 of them being co-produced in Spanish. What you find in many respects is what you might expect – the largest category was related to approvals. But there are some unexpected things as well – the second largest category was about FDA enforcement actions. About half of all press releases were about product approvals, which one might expect. However, the number of bilingual releases varies considerably by category. In the end, while each press release is important, it is also good to get perspective about the body of communications issued by the agency. A piece of pie is great, but one should appreciate the whole as well.

And here is a breakout as the releases affected different sectors:

Approvals (81)

  • 61 Drug Approvals
  • 19 Device Approvals
  • 1 Tobacco-related Approval
  • 26 of these were also produced in Spanish

Alerts (9)

  • 6 Regarding Drugs
  • 2 Regarding Food and Beverage
  • 1 Device
  • 3 of these were also produced in Spanish

Legal Actions (26)

  • 10 related to Drugs
  • 10 related to Food and Beverage
  • 5 related to a Supplement
  • 1 realted to Devices
  • 3 of these were also produced in Spanish

Recalls (12)

  • 10 Drug recalls
  • 1 Device recall
  • 1 Pet food recall
  • 1 of these was also produced in Spanish

Rule Making (23)

  • 7 related to Drugs
  • 7 related to Devices
  • 7 related to Food/Beverage
  • 1 related to Soap
  • 1 related to Tobacco
  • 12 of these were also produced in Spanish

Grant Making (3)

  • 1 related to Drugs
  • 2 related to Devices
  • None of these were also produced in Spanish

The balance fell into a category I called General Announcements which was a collecting place for miscellaneous releases.

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