Weekly Roundup 3.27.15

Another busy week – hence a day late with the Weekly Roundup.

This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems.  They took them away today.  It is a good feeling. There are about 100 bags left to fill. That is a bad feeling.

It is the time of year where there are crazy temperature ranges. It was 75 degrees this week here in Washington and there is a call for snow mixed with rain. There was a thunderstorm forecast. But the daffodils are up and about to strut their stuff.

It was a relatively quiet week comparatively speaking on the FDA front, but here are a few tidbits.

  • FDA Approves Inhalation Anthrax Treatment – This week the agency announced its approval of Anthasil in inhalation form to treat inhaled anthrax exposure in combination with other appropriate antibacterial drugs after rare exposure to infected animals or other exposure to spores. This product had been purchased under the authority the Biomedical Advanced Research and Development Authority (BARDA)  - and the approval by FDA means that emergency authorization for its use would no longer be required. The nature of the condition being studied meant that this approval was based on animal studies and the product is made from the plasma of persons who have been vaccinated against anthrax exposure because their plasma has antibodies that act to neutralize the toxins generated by exposure.
  • Blood Pump Approval – The agency announced approval of a new blood pump system for use with patients suffering effects of coronary artery disease (CAD) who are undergoing high risk procedures such as stent placement or angioplasty, known as high risk percutaneous coronary intervention. The pump is introduced prior to a procedure through a catheter. Heart function is measured and externally monitored and the pump is employed as necessary to help maintain stable heart function during the procedure. The company press release can be found here.
  • Draft Guidance Development and FDA – For those who have waited for the development and issuance of a specific guidance by the agency – and waited, and waited, and waited, you may think it is just you being impatient, or just your guidance that is taking a long time to develop. In that case, you may want to take a peek at the nice overview Ed Silverman did at Pharmalot that describes just how long some guidance documents have taken to develop. As often said here, these guidance documents, along with warning letters, are the only windows into the agency’s current thinking. With the documents taking a long, long time and warning letters having slowed to a trifle the result is less transparency, not more.

That’s it for me this week folks. Have a good weekend.

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Is Bigger Safer? OPDP Enforcement Patterns and Company Size

Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued by the agency, are one of the ways that industry can gain insight into FDA’s thinking on a wide array of topics, including the regulation of speech related to drugs and biologics.

In the past few years, enforcement by OPDP has dropped off considerably – at least as measured in the number of regulatory action letters that were issued. Not so very long ago, the agency used to issue scores of letters in any given year – in 1998 there were over 150 letters issued. Thereafter the number of letters fell off though in 2009 – 2011, there was a slight increase. But then last year, OPDP slowed to a crawl, sending out letters to ten companies, less than half of the 22 sent the previous year and only about a third of those sent out in 2012.

But looking beyond the numbers at the letters sent the past few years, one can also readily see that the recipients of the letters tended to not be the pharma and biotech companies that you might readily be able to name. Smaller companies seemed to be predominant when it came to enforcement.

To see if this impression was correct, I used as a yardstick of company size the Pharma 50 published in Pharmaceutical Executive which lists the top 50 companies by sales.  I cross-referenced the names there with the names of recipients of the regulatory action letters over the past few years from my Warning Letter Database.  Here is what I found:

  • 2015 – There have been only three letters issued by OPDP this year. Of those three, zero were included in the Top 50.
  • 2014 – Of the 10 letters, one (10%) was received by a company in the Top 50.
  • 2013 – Of the 22 letters in this year, five (23%) of the letters were sent to companies in the Top 50.
  • 2012 – During this year, there were 28 letters sent out by OPDP ten (36%) were sent out to the Top 50.
  • 2011 – OPDP sent out 31 letters, eight (26%) of which went to companies in the Top 50.

That is a total of 94 letters in all.  Twenty-four (25.5%) of which went to companies in the Top 50.

What does that say? On its face, nothing conclusive. Large companies are likely to have much more promotional language about more products but also likely to have more experience and probably more internal controls than less experienced companies.

However, one note – in 2010, there were 52 letters issued by OPDP.  Half of them went to companies in the Top 50.

Perhaps the reason is that there have been a number of emerging companies on the horizon, so the pool of smaller companies is expanding. In any case, it has represented an interesting trend of note in OPDP enforcement.

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Weekly Roundup 3.20.15

There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that Spring starts today.  As to that though, you wouldn’t know it to look around Washington, D.C. or anywhere around the East Coast I should think – where we see snow falling outside the window today, though Spring does not officially start until 6:45 this evening here. And tomorrow promises sunshine and moderate temps.

Here is a bit of what happened this week:

  • FDA Approves New Drug for Bile Acid Synthesis Disorders – Another in what has been a long string of FDA approvals for new products that treat rare disorders, the agency announced this week approval of Cholbam for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects. People with this disorder experience a reduced bile flow and accumulation of potentially toxic bile acid intermediates in the liver and malabsorption of fats resulting in possible liver injury.
  • Opioid Abuse Hearing – The House Energy and Commerce, Subcommittee on Oversights and Investigations announced that it has set March 26 for a hearing “Examining the Growing Problems of Prescription Drug and Heroin Abuse:  State and Local Perspectives“. The slate of speakers has not yet been posted but will be found here. Also this week in related news, it was reported that members were applying pressure to FDA to issue its guidance on abuse-deterrent opioids.
  • Ebola Vaccine AdComm - A meeting of the Vaccines and Related Biological Products Advisory Committee was announced this week for May 12 to consider the development and licensing of vaccines for Ebola. When posted, meeting materials will be found here. On a related note, there was also a posting on FDA’s Voice Blog called Turning the Tide on Ebola describing on the ground work in Liberia.

I have some good stuff coming up if I can just get time to tend to it. In the meantime, enjoy this first weekend of Spring!

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Weekly Roundup 3.13.15

On the road this week left little time for posting, though some interesting things happened. And meanwhile, back in Washington, D.C., the last vestiges of snow have departed and on my dog walk, I spotted blooming purple crocuses which was nothing short of thrilling. Daffodil spikes also appeared quite robust. My mood lightened considerably.

And here is some of the important stuff:

  • FDA Approves First Therapy for High Risk Neuroblastoma – Neurobalstoma is a rare, but tragic cancer primarily affecting children under the age of five years. Despite aggressive therapy, patients have only a 40-50 percent chance of long-term survival. FDA announced this week the first approval for a therapy against it. Unituxin (dinutuximab) is an antibody that binds to the surface of neuroblastoma cells and is being approved to use as part of a multimodality regimen that includes surgery, chemotherapy and radiation therapy who have achieved at least a partial response to prior first-line multiagent, multimodality therapy. The approval is yet another in a recent stream of medical treatments that are directed to rare conditions and had orphan product designation along with priority review. The company press release is here.
  • Reusable Medical Device Guidance – A final industry guidance was announced by FDA this week aimed at reducing the risk of spreading infectious conditions through the use of reusable medical devices entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling“. The guidance lists criteria for the instructions that come from manufacturers to ensure that end users understand how to reprocess durable medical equipment for reuse. The guidance also recommends that manufacturers consider reprocessing challenges early in device design. In its press release, FDA emphasizes that the risk of acquiring an infection from a reprocessed device is low though within the same release refer to an upcoming meeting of the Gastroenterology and Urology Devices Panel to discuss recent reports and investigations into transmission of infections with particular device use.

That’s it for me this week.  Hope to be more freed up next week. In the meantime, have a good weekend – the first on Daylight Savings Time!

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Weekly Roundup 3.6.15

I found myself dreaming about picking herbs from my herb garden and thinking of expanding my efforts there this year to include new items. I imagined flowers blooming out on back deck. And these whimsical thoughts all occurred while I prepped the porches for the latest onslaught of snow and ice with shovels and salt.

Soon. Spring is only a few weeks away and this weekend, Daylight Savings is upon us!

In the meantime, here is a bit of what happened this week that caught my eye in case you missed it.

  • First Mobile App Launched by FDA - Catching up to the times, FDA announced this week that it was launching the agency’s first mobil app that was designed to speed public access to information about drug shortages.  Apparently aimed at health care professionals and pharmacists to give them real time information about drug shortages to support informed medical decision making. Certainly for the many physician offices are turning to pad based technologies to support them in their offices the app should serve a convenient role to expedite information gathering. The app is available for free download via iTunes and the Google Play Store by searching “FDA Drug Shortages” or presumably just “FDA”.
  • FDA Spotlights Testosterone Products - The agency issued a drug safety communication this week regarding testosterone products. The agency was cautioning about the use of products for low testosterone due to aging and was requiring a label change to inform of the possibility of increased risk for heart attack and stroke. The agency noted that the products are approved only for low T-levels due to particular medical conditions – not aging. The communication was issued following an advisory committee meeting held on the topic and following a review of studies where some demonstrated a risk and others did not.

That’s it for me this week folks.  Let’s hope this is the last snowy, icy weekend. Don’t forget to Spring Forward Sunday morning at 2 AM.!

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