Weekly Roundup 4.8.16

I put the herbs into the garden on a warm and balmy day last weekend only to fall victim to freeze warnings a day later so brought them in the house. Warms up. Put them back outside and then another freeze warning. Bring them back in the house. Warms up. They are outside now but tomorrow there is a prediction for some snow…. Am seriously now thinking of just turning the dining room into my new herb garden….

Wherever you are, I hope there is Spring in your present, if not your near future. In the meantime, some interesting stuff happened this week and here is a little bit of it.

  • Help for Making a Mobile Health App – If you are trying to create a mobile health app you may find yourself needing help in sorting out the various regulatory compliance issues. FTC?  FDA?  HIPAA?  Alphabet soup?  This week, FTC came to your rescue when it posted on its website an interactive tool designed to help you find out which federal laws you need to follow. Produced in cooperation with HHS, the Office of the National Coordinator of Health Information Technology, the Office for Civil Rights and the FDA, the tool sets forth a series of yes/no questions that inform a developer of which laws apply to the project in question.
  • FDA Approves New Biosimilar – For only the second time, FDA announced this week the approval of a new biosimilar for use in the U.S.  Called Inflectra (infliximab-dyyb), it was approved for multiple indications – all of which were the same as the indications approved for the reference product Remicade (infliximab) which includes moderate to severe Crohn’s disease, moderate to severe ulcerative colitis and rheumatoid arthritis, and others. Indicating the need to educate the public about this emergent area of medicine, in its press release, FDA went out of its way to explain the nature of a biologic and a biosimilar and the approval process (though did not explain the naming). You can see the company press release here.
  • Growth in Number of Organic Food Producers – Not an FDA story, but an interesting food story nonetheless – USDA reports that according to data from the Agricultural Marketing Service National Organic Program, he number of U.S. certified organic operations has increased nearly 300 percent since 2002 and 12 percent between 2014 and 2015. As almost anyone who shops for food can tell you the number of stores offering organic choices has certainly increased. In the release on the topic, USDA also referenced a resource – the Organic Integrity Database run by the agency where you can look up specific organic operators and see what products are certified as organic.

That’s it for me this week. On Monday I will be sharing some thoughts with you about an important emerging issue and the real need to be planning ahead of the curve. Until then, have a good weekend everyone.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

More or Less – FDA Press Releases 1st Quarter 2016

There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not one of those times, but the volume of material slowed this year compared to the same period in 2015.

Keeping track of what the agency says and when it says it is just one means of monitoring activity. I track the releases and categorize them and have 520 of them going back through 2013. I just went through a lengthy process of updating and correcting entries going back through last year and thought it would be a good idea to provide you with a comparison of last year at this time with the beginning of this year. There were a few things of note:

  • Looking back to the first quarter of 2015, the agency issued 46 press releases, compared with the same quarter a year later when 32 were issued.
  • Perhaps most noteworthy were the announcements involving approvals. In the first quarter of 2015 when it was a record year for approvals, FDA announced 31 during the first quarter – 11 were devices 19 were drugs and 1 was an app. In 2016 during the same period, the agency announced only 13 approvals – 4 were devices and 9 were drugs.
  • Otherwise, the announcements were very much on par with last year. In 2015, there were 6 general type announcements, 7 related to legal issues (seizures, consent decrees, e.g.) and 2 rule/guidance related releases. In 2016 there were 9 general announcements, 6 legal and 3 policy or rule announcements.

Does the drop off in approval announcements for the first quarter of this year signify that this year will not see as many approvals as were seen during the banner year that was last year?  A single quarter is only a short measure in time and lots can change over 3 quarters, but it is an early indicator that we should continue to look at – and will.

(So far in April, there has been another approval announcement.)

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in FDA Image, FDA Policy | Comments Off

Weekly Roundup 4.1.16

The year is now officially one-fourth done. We have a long, hot summer to slog through that will no doubt be followed by a tumultuous autumn election cycle, so it is perhaps best now to take time and enjoy the budding green, the delicate blossoms, the fragrant breezes and appreciate them fully.

That’s my advice anyway. And here is a bit of what was interesting in an very interesting week:

  • Revised Labeling for Mifepristone – First approved in 2000 for use in terminating  an early pregnancy, mifeprisone has had a label change to reflect the experience with the drug since it came to the market. This week, the label was revised to update both the dosing regimen and the route of administration as well including a modification to the gestational age up to which the drug has been shown to be safe and effective and the process for follow-up administration of the drug. The REMS program associated with the use of the drug was also updated. FDA set up a Q&A page regarding the changes.
  • Zika Blood Screening Test Made Available- As mosquito-summer months approach, another plank has been added to the public health platform being built around the potential for Zika transmission in the U.S.  This week FDA announced that an investigational test was cleared for use to screen donated blood for Zika to be utilized in areas where there has been active transmission. Making this screening tool available follows on the heels of the issuance of a guidance last month on donor screening and protecting the blood supply. On a related note, the World Health Organization announced this week that it had received notification of the first cases of transmission in Cuba and Domenica (which had resulted in the CDC posting a notice for those traveling to Cuba.
  • AdComm Recommends Approval for Parkinson’s Psychosis Drug – This week at a meeting of the Psychopharmacologic Drugs Advisory Committee members considered a new drug application for NUPLAZID (pimavanserin) for use in treating psychosis in patients with Parkinson’s. The drug application has Priority Review and has been designated as a Breakthrough Therapy. The ultimate vote on benefit/risk for the drug was 12-2 and the date for FDA action was acknowledged in the company release to be May 1, 2016. Background documents from the meeting can be found here.

That’s it for me this week folks. Have a good weekend and don’t fall for any April fool’s jokes!

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

Once and Future AdComms Affecting Drug Applications

One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To that end, I have a little database that tracks activity going back through 2009 – looking only at those advisory committees that are listed under the “Drugs” tab on the FDA website.

Let’s begin by looking back to last year, then we’ll look forward to this next month.

During the first quarter of 2015, FDA held 8 advisory committee meetings, 6 of which involved new drug or supplemental new drug applications. Of those 6 meetings, the advisory committees recommended approval in 5 of them. Of those 5, FDA went on to approve 4.

By contrast, we are off to a bit of a slower start in the first quarter of 2016. There have been a total of 4 AdComms this quarter, all of which involved new drug considerations. Of those, the Advisory Committees recommended approval in all four of them, including one which was a biosimilar to reference product Remicade and in one that occurred yesterday. With regard to approvals, FDA final decisions as of this writing and the PDUFA date for one of the products has been extended by the agency. As you know, FDA is not bound by the determination of an advisory committee.

As for upcoming meetings, in April there are three meetings scheduled to consider new drugs:

There will also be a meeting of a few device panels in April as well as the Pediatric Advisory Committee – All meetings are listed here.

At the conclusion of this quarter in a few days, we’ll review FDA press releases compared to last year at this time, including approval announcements.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Advisory Committee Prepapartion | Comments Off

Weekly Roundup 3.25.16

Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week.

And here is what was blooming this week involving FDA – there were a cluster of new approvals, coincidentally – all monoclonal antibodies:

  • Anthrax Treatment Approved – First off, on Monday the agency announced the Friday approval (unusual timing) of a new treatment for inhalation anthrax. The treatment, Anthim, is a monoclonal antibody that neutralizes toxins from the anthrax and was approved under the “Animal Rule” which allows the consideration of testing on animals in lieu of humans where it is not feasible to do them in humans. The company press release can be found here.
  • New Plaque Psoriasis Drug Approved - Taltz, a monoclonal antibody, was approved this week by FDA for the treatment of moderate to severe psoriasis, FDA announced. Taltz acts to counter the effects of psoriasis, an autoimmune disorder, by binding to the protein that causes inflammation in psoriasis and thereby inhibits an inflammatory response. For a more in-depth discussion about the clinical trials leading to the approval, see the company press release here.
  • New Asthma Option Approved – People suffering from severe asthma despite treatment now have a new option with the approval announcement from FDA this week of Cinqair. The treatment is administered by a health care professional once every four weeks and works by reducing the amount of blood eosinophils, a white blood cell that contributes to the development of asthma. The company press release can be found here.

That’s all for me this week – I’m taking a little Spring Break. Have a good weekend everyone.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off