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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Weekly Roundup – 2.21.14

The snow has melted and the ground is soggy.  Looking at the ground there are daffodil tops poking out of the dirt and this morning on my dog walk, I spotted my first two crocus blooming purple.  The volume of birdsong has definitely increased.  And I find myself in moments where there is a quick mental break, with a wandering mind considering the scheduling and destinations of spring vacations.  Daylight savings is just 16 days away…

In the meantime, it looks like it was a fairly eventful week and here is a bit of what happened:

  • Supply Chain Pilot Program for Drugs Launched - In August 2013, FDA published a notice in the federal register seeking pharmaceutical company participation in a pilot program aimed at bolstering the security of the supply chain for drugs imported into the U.S.  The participating companies would agree to have in place a supply chain protocol validated by U.S. Customs-Trade Partnership Against Terrorism; a plan in place to quickly address potential problems; effective recall plans in place and maintenance of control over the drugs from time of manufacture through entry into the U.S.  Participants are permitted to have up to five drugs receive expedited priority import entry review.  You can see the thirteen companies that have been “pre-qualified” to participate in the FDA press release and there is a Web page on the FDA site devoted to the topic.
  • Another Orphan Product ApprovalThis week FDA approved Chelsea Therapeutics’ Northera for the treatment of neurogenic orthostatic hypertension which is a rare, chronic and debilitating condition often affecting people with Parkinson’s Disease.  People with the condition face a sudden drop in blood pressure upon standing.  The product was approved with a boxed warning and under FDA’s accelerated approval process.
  • FDA Looking to Overhaul OTC Monograph SystemFDA announced this week that it would be holding a public hearing on March 25-26 at the agency’s White Oak campus with an eye toward modernizing the process and regulatory framework for OTC Drug Review under the Monograph Process to make it more responsive.  The purpose of the hearing is to solicit opinions about how to better position the system in today’s environment.  The OTC Monograph system currently provides for the ability to categorically set standards for OTC products so that they do not have to get approval under the new drug approval process individually.  However this process put into place four decades ago is somewhat cumbersome.  FDA cites particular challenges including the fact that there are a large number of products marketed for which there is not a final monograph available.   FDA has set up a meeting information site on the Web site.  This will likely be the most important meeting regarding OTC drugs in many years.

That’s it for me this week.  The weekend feels like it was a long time in coming.  I plan to greet it with open arms.  Enjoy.

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Building a Case, FDA AdComm Prep – Part 3 (final)

In Part 1, we covered the need for good communications planning, in Part 2, a little bit about how to go about it and in Part 3, some thoughts about the day of your meeting.

You have developed your narrative and from it derived the individual components of the presentation on need, safety, efficacy and any other considerations.  You have looked at the warts – and asked the hard questions about the data and issues that relate to the risk/balance ratio – like the number needed to treat and the possible safety issues, the potential for a REMS program, how special populations might be affected, how the trials were conducted and recruited, the makeup of the clinical trials, etc.

Now you have chosen your presentation team.  It may be a combination of internal and external team members.  External consultants can be very useful and credible, particularly if they have a background associated with the drug approval process or connection with a major medical society related to the treatment area.  You establish “leads” for responses in key areas, with back up experts to be called upon for highly specific information.

The presentation team needs training not only in presentation technique, but in question response.  Speakers particularly need to be taught flagging and headlining as it related to providing the answer in a meaningful way; and need to be practiced and rehearsed on a range of questions.  In fact, the presentation team should be prepared not only with mock panels made up of outside experts to simulate the day of experience, but drilled frequently on the range of potential questions they will face.  And conduct as many mock panels as are necessary.

In addition, a sponsor must identify those people who will be responsible for speaking with the media and they must be media trained – not the same as presentation training. Which brings us to an important point.

The AdComm meeting is not just a scientific meeting about the approval of a compound – it is also where the baton gets handed off from the regulatory side of an organization to the marketing side.  The AdComm meeting is where the branding of the product draws its first breath – it is the public unveiling of the drug – warts and all, and therefore it is important that there be a coordination of communication between regulatory and marketing at this time.

A good deal of sponsor thought goes into the Open Public Comment (OPC) period of a meeting when third parties and patients can state a point of view.  Should a sponsor encourage third parties to participate?  Support and connections of sponsors for third parties need to be disclosed at the time.  Such connections have an impact.  Purely organic commentary is perhaps the most desirable.  However, in any case, OPC should be considered carefully.  No panel is interested in being condescended to or patronized during this part of the meeting.  The most useful kind of OPC participation occurs when those offering commentary are shedding real light on an issue – particularly the human face to the condition.  If the condition is one commonly understood by everyone, that is probably not necessary.  If, on the other hand, it is a condition that needs a human face, it can be quite useful.  I have seen good examples of this and bad.  Each must be assessed on a case by case basis.

Finally, from a media point of view, it is a good idea to understand the media environment for your day.  Are there other FDA AdComms meeting that day – unusual, but not unheard of – that could overshadow or blunt your coverage?  Are there hearings on the Hill that could do the same?  Look at the social media commentary from the last meeting in this space and develop your own social media listening approach to the meeting.

In the end, it is about data, data and data.  But good skills, good planning and even good luck still are factors not to be ignored.

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Weekly Roundup 2.14.14

Well, I am really tardy with this posting – the Weekly Roundup is not only late, it is real late.  Sorry, it was not Valentine’s Day festivities, nor was it a result of the snow storms – some of which left my herd grazing on snow.   It was just really busy and I was a bit stretched.  And I didn’t think in the end, anyone would truly mind.

But there were a few things of note, particularly this first item, so here it is, better late than never:

  • FDA Seeking Public Comment on DTC – The agency announced this week in the Federal Register that it would be seeking public comment on its research related to “Disclosure Regarding Additional Risks in DTC Prescription Drug Television Ads”.   The comment is on the collection of information, but in this notice FDA lays out its hypothesis about DTC ads as currently implemented with the “major statement” are too long thereby undermining patient comprehension.  In other words by being thorough and complete one is being boring and uncommunicative.  The ad warnings may be so long and involved that it does not penetrate with the audience.  On the other hand, how to get the information that is important into the ears and minds of patients?  How to solve the issue?  FDA is going to embark on a study with participants who have been diagnosed with one of three possible medical conditions who will view different versions of ads to assess risk comprehension.  Should be interesting.  You can see more about the study design in the Federal Register notice.
  • First Drug to Receive Rare Pediatric Disease Priority Review Voucher Approved - The agency announced approval of Vimizim to treat a rare congenital enzyme disorder called Morquio A syndrome.  The condition is caused by a deficiency in a particular enzyme which can lead to problems with bone development, growth and mobility and is so rare that the press release states that there are only 800 patients diagnosed in the United States.  The drug got priority review designation and prior to the approval there were no approved drug treatment options.
  • New Approval to Treat CLL - A new treatment for chronic lymphocytic leukemia called Imbruvica was approved under accelerated approval  to treat patients who have received at least one previous therapy.  In addition to being approved under accelerated approval, the new treatment was orphan-product designation.  According to the press release, CLL is a rare disease of the blood and bone marrow that gets increasingly worse over time and causes a gradual increase in white blood cells.

There (finally) is the Weekly Roundup for this week.  For those of you having a long weekend due to the holiday, I hope you have a good and restful one.

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