Weekly Roundup 1.23.15

It seems 2015 is moving even faster than 2014 as we prepare for the last week of January even though it feels as if the holidays were only last week. It has been that time of year for reflection, looking back at what we’ve done and forward to what needs to be done. And looking forward as well to Daylight Savings which is March 8 this year. Counting the moments….

In the meantime, a bit of reflection on some events of this week:

  • FDA Clarity on Wearables - In 2011 the agency had issued a draft guidance with respect to medical apps and a final guidance in 2013. In that guidance, FDA stated that it was aiming for functionality and not platform in its approach to regulating apps. In that guidance, the agency said that many mobile apps aimed at health were not devices and would not be regulated and many might be devices, but would not be regulated because they were low risk. The guidance aimed regulation at those apps which were devices and could pose risk if they failed and termed these regulated devices as mobile medical apps. This week FDA issued a draft guidance on the policy for low risk devices (wearables) which expresses it a bit differently but the effect is the same – FDA is not looking to regulate general wellness products and present low risk. The agency outlines the parameters in the draft guidance very clearly and provides not only examples, but a decision-tree as well in the draft entitled “General Wellness: Policy for Low Risk Devices”.

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

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Review of Warning and Untitled Letters for 2014

Earlier this month, I had posted about the steep decline in FDA’s OPDP enforcement rates as the number of Warning and Untitled letters for 2014 hit a new low of only ten for the year. In the posting, I had mentioned that while I usually do a quarterly overview of the letters, this year there were insufficient numbers to do that – so here is an annual review of the types of violations and also a comparison to those issued in 2013.

As regular readers know, the data comes from a data base of warning and untitled letters I maintain that includes all letters going back through 2004. It now profiles over 300 letters, characterizing them along a number of fields including treatment area, communications vehicle type, digital or non-digital, whether the product had a boxed warning, and of course types of violations.

In 2013 there were over twice as many letters (24) compared to 2014 (only 10). The letters in 2013 included 63 violations (2.7 violations per letter) compared to 2014 when there were a total of 25 violations (2.5 violations per letter).  Do fewer letters and fewer violations in 2014 connotate a better ability of industry to devise communications within regulatory guidelines?

Not only are there fewer letters (for both years) but it would appear that there are fewer Warning Letters, the more serious missive from OPDP.  And despite the fact that digital communications are on the rise, the proportion of digital versus non-digital communications vehicles has not increased.

Finally – what types of violations occurred?  As usual, risk minimization was the most frequent violation, followed by claims of superiority and unsubstantiated claims.  The following is profile by proportion by year:

One of the striking things about both years is that nearly all of the letters were directed to smaller-sized companies – not the ones that are generally considered household names, particularly when looking at 2014.

So in sum, fewer letters, fewer violations per letter, fewer expressions of serious violations, fewer large companies involved. If the volume picks up, Eye on FDA will go back to quarterly reviews.

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Weekly Roundup 1.16.15

It is a three-day weekend! Granted we just had the holidays, but they are very filled with exhausting activity – decorating, receiving guests, being a guest, wrapping.  We need some recover time and in the spirit of the weekend, to take stock of the ways in which we can make the world a more peaceful place. Here is a bit of what happened this week:

  • A Device to Treat Obesity?  FDA Approves One. FDA announced approval this week of the first-of-its kind device to treat obesity. The device – the Maestro Rechargeable System – is also the first device approved by FDA for obesity since 2007.  It consists of a rechargeable electrical pulse generator, wire leads and electrodes which are implanted surgically into the abdomen and then sends electrical pulses to the abdominal vagus nerve which is involved in regulating stomach emptying and signaling to the brain that the stomach is full. The approval came despite the fact that the clinical study did not meet its original endpoint of having the treatment group lose at least 10 percent more weight than the control group.
  • Drugs and Driving – FDA Draft Guidance - This week FDA issued a draft guidance Evaluating Drug Effects on the Ability to Operate a Motor Vehicle” with the purpose of assisting drug sponsors to evaluate the effects of psychoactive drugs on the range of activities necessary to drive – cognitive and perceptual. Public comment is being opened and those interested in viewing and providing comment can do so at www.regulations.gov - when you get to the site, perform a search for the draft and the docket.
  • Senator Schumer Calls for Greater Transparency and Heightened Inspection on Food Violations -  The Office of Senator Charles Schumer (D-NY) announced this week that it had sent FDA a letter urging FDA to implement new steps that would address recent reports of rat-invested warehouses that supply food materials across the country to restaurants. In particular, concerns focused not only on the unsanitary conditions, but the lack of transparency that left the customers for these goods largely unaware of the violations at the time they are cited, meaning that purchases could continue while uninformed by the circumstances.  Among other things, he called for a readily searchable database to better inform the environment, increased inspections and greater penalty for violations.
  • A New Congress Opens Up for Business – In case you missed them, most of Congress has returned and opened up the 114th Congress, bringing with them new members and, in the case of the Senate, new leadership. Committee chairs are being occupied by new members and new legislation is already being introduced.  Accordingly on the Eye on FDA Website, there is a tab – “Proposed Federal Legislation – 114th Congress”  that will overview new legislation that is introduced that would have an impact on agency policy or industry practice.

That’s it for me this week.  Taking Monday off and wishing you all a good, safe weekend. Peace to all.

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FDA Press Releases – 2014 What They Said and How They Said It

Last year, Eye on FDA had a posting that examined the press releases of the previous year, relying on a new tracking system I had implemented for that purpose.  This being the second year of the database, we can not only see what FDA had to say about what – but we can now compare some of the numbers to 2013.

Looking first at volume, the numbers were very similar.  In 2013 the agency issued 165 press releases, slightly more than the 161 released in 2014.  Reflecting the significant number of approvals during 2014, however, a higher percentage of the announcements were regarding approvals (represented in dark blue).

There were fewer alerts issued and fewer recalls in 2014 than in 2013.  There were approximately the same number of legal actions.  On the approval side, when it comes to types of approvals, there were actually roughly the same number of drug/vaccine approval announcements in 2014 as in 2013 (60 versus 61 respectively), however the number of announcement involving devices/tests grew considerably from 20 in 2013 to 30 in 2014. As with 2013, legal actions was the second highest category after approval announcements.

The number of press releases that were translated into Spanish rose slightly in number and proportion this year.  In 2013, 29.7 percent (49) of the FDA press releases were bilingual and in 2014 there were 33.5 percent (54) also available in Spanish. Still not discernible is any pattern to predict when a release would be translated.  For example, many, but not all, approval announcements are translated.

That’s the look back at what FDA had to say in 2014 and how they said it.

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Weekly Roundup 1.9.15

The New Year has gotten off to a very chilly start here in Washington, D.C. But we have a new Congress that has been sworn in as the 114th.  I have cleared the Eye on FDA tab on the blog site to pave the way for new proposed legislation that would impact the FDA and the medical products industry. We are also poised for turning some additional corners at FDA as noted below.  And it is that time when we put our resolve to the test regarding our resolutions to make our own changes.

  • FDA’s ODAC Recommends Approval for Biosimilar -While generic chemical drugs have long been available, providing access to treatment at a reduced cost, the equivalent for biologic treatments has long been awaited.  As part of the Affordable Care Act, FDA has been constructing a regulatory pathway for the consideration and approval of biosimilars.  This week, a meeting of FDA’s Oncologic Drugs Advisory Committee (ODAC) considered an application to approve a drug that would be marketed as a biosimilar to Neupogen.  The panel voted 14-0 to recommend approval and if FDA accepts that recommendation and approves the drug, it would be the first biosimilar to enter the U.S. market. The proposed name for the new biosimilar for Neupogen is Zarxio and you can read additional media coverage of the meeting here and see the company press release here.
  • FDA Announces Ambitious List of Guidance Docs for 2015 - Each year FDA publishes a list of those guidance documents that it is aiming to put out for the year. It is a goal – some do not make it – and it is possible that there will be others not listed here that end up coming out.  In any case, there are a LOT of them and the list categorizes them.  It is notable that 6 are in the category of advertising, including one related to social media – Use of Links to Third Party Sites.  In addition, related to the story above, there are 4 related to biosimilars. Check it out.
  • Approval for Multiple Indications for Savaysa – The agency made its first approval announcement for 2015 for Savaysa, made by Daiichi Sankyo.  The anti-clotting drug was approved for multiple indications to reduce the risk of stroke and blood clots in patients with atrial fibrillation that is not caused by a heart valve problem and to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug administered by injection or infusion for five to ten days. The drug comes with Boxed Warning and it will be dispensed with a Medication Guide.

That’s it for me this week folks.  Hope that 2015 has gotten off to a good start for you and remains so throughout the year.  And, if you are in one of the areas affected by extreme cold – stay warm and cozy up.

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