Goodbye Dr. Hamburg

In lieu of the Weekly Roundup this week, the report is dedicated to a sole development – the announcement by Dr. Margaret Hamburg of her departure from FDA after six years as FDA Commissioner. She leaves behind a number of accomplishments and an FDA that is in considerably better shape than the one she took over in 2009.

Prior to her arrival, the agency that regulates approximately one-quarter of the U.S. economy had seen a series of commissioners, some with very short tenures. Between 2000 and 2008 there were many months where there was only a commissioner in an “acting” capacity. In addition, during that time, there were many high profile issues that served to shake public confidence in the organization – high profile drug recalls, an episode where politics appeared to interfere with science to keep at bay an RX to OTC switch of a contraceptive; influenza vaccine found contaminated by British authorities rather than FDA; a salmonella outbreak where it took months to resolve the source.

Since taking over the helm of FDA, Dr. Hamburg has taken steps to restore confidence and provide a continuity of leadership the likes of which the agency has not seen for a long time. Early on she instituted an expansion of transparency within FDA with the launch of FDATrack.  During her tenure FDA moved to new quarters that could more reasonably house the activities and staff of the agency. The agency saw its authority extended to regulate tobacco and has been putting into place the machinery for doing so. FDA responded to the burgeoning area of medical app and wearable device development by carving out responsible oversight. Legislation paved the way for the construction of a regulatory pathway for biosimilars which is now underway. But perhaps most importantly, FDA has put into place mechanisms to not only facilitate drug approvals, but the approval of drugs for rare and life-threatening conditions with the advent of Breakthrough Therapy status and Priority Review. During 2014, FDA had approved the most drugs of any year in the past ten and more approved during the past five years by far than the five previous to her arrival.

That leaves some big shoes to fill for the next Commissioner.The biosimilars regulatory landscape needs to be filled out, with policy questions open on that front. Proposals are being floated to take the F out FDA and move food safety to an independent agency. And even though the pace of drug approval has hastened, and there are calls among many policy makers for measures that would speed development up even further, a goal always challenged by concern for safety.

The work has doubtless been difficult, but rewarding. Congratulations to Dr. Hamburg and best wishes.

You can see a list of past FDA Commissioners here.

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How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement

One of the benefits of tracking the regulatory actions of FDA through the Office of Prescription Drug Promotion (OPDP) is that it allows you to take the information and view it from different perspectives to look for interesting lessons and insights.

Having tracked Warning and Untitled letters for the years 2004-2015 inclusive (though there have not been any yet this year) in a database, one of the fields noted is the communications vehicle involved in a violation cited by the agency – everything from websites to sales aids to videos and more. The database now has over 300 letters and over 1000 violations.

While there are numerous communications vehicles involved, I chose to look at 4 specific fields: Websites, Video, DTC and Oral Statements. What we can see is that the profile of violations for Websites, Video and DTC are relatively consistent – with risk minimization or omission being the most common violation across the three – when it comes to oral statements, Risk Minimization/Omission is on par with promotion of an unapproved use (PUU – ORANGE SLICE), which had had a very low or non-existent profile with the other vehicles. Other areas that stood out, with DTC there as a much higher profile for making a Superiority Claim (RED SLICE) while in video there was a higher profile for Overstatement of Efficacy (GREEN SLICE).

Websites are obvious – those digital properties where material is posted and refers specifically to printed copy on the Website.

Video refers to video properties that were either placed on YouTube or resided on a Website. If the latter, it was not counted in the Website statistics.

DTC is a broad category and can include print or broadcast.

Finally oral statements are comprised of statements made by various representatives of manufacturers and include sales reps in doctors offices, personnel in exhibit booths at conferences, researchers and even CEOs in media interviews.

There are many insights one can draw from the information and further insights may merit delving further down into the specific examples within each grouping.  But clearly communications vehicles tend have different regulatory enforcement profiles. Some vehicles – like oral statements – where you see a greater propensity for PUU – great care needs to be taken to ensure strong messaging and training of speakers. Video also has its own unique profile and clearly the more latitude the means of communication, the more chance there is of making statements that take one into troubled territory. In short, knowing the regulatory profile of your communications vehicle can help you plan and prepare to take steps that might minimize regulatory risk.

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FDA’s Novel Year of Novel Drug Approvals – 2014

Of course it is more than a roll of the dice. A lot of work and effort goes into medical treatment applications for approval and into evaluating them for consideration. As was widely discussed in FDA-watching circles, the agency approved a total of 41 novel new drugs in 2014 – the most in a decade. Novel new drugs are are a subset of the overall number of new product approvals and often represent those drugs which offer an advancement in patient care  and public health in some way.

In January FDA published a report – Novel New Drugs 2014 Summary – that provides a very comprehensive overview profiling the new drugs approved in 2014. Here are the highlights:

  • Over the past decade, the number of novel new drugs approved each year was 25. This year FDA approved 41 – if I’m not mistaken that would be a 64 percent increase over the average;
  • 17 (41 percent) of the 41 NMEs approved were first-in-class drugs;
  • 17 (41 percent) were for rare diseases;
  • There were 4 new approvals for Type 2 diabetes and 3 for acute bacterial skin structure infections
  • 17 of the drugs were on FDA’s Fast Track
  • 9 were given Breakthrough status
  • 25 of the drugs had Priority Review
  • 8 of the new approvals were under Accelerated Approval (note that these classifications are not mutually exclusive and a drug could have been given more then one of these designations – for a definition of each, see here)
  • The agency met PDUFA dates in 40 of the 41 NME approvals (98 percent)
  • 26 (63 percent) of the drugs were first approved in the U.S.

In the report, FDA provides an overview chart for each drug that ticks off the various characteristics of its approval and even lists the dosage form. In addition, there is further more detailed information about the approvals.

Overall, a banner year for the agency with respect to NMEs – one that may be tough to beat. So far January has seen several approvals for drugs and one for a novel device to treat obesity.  We’ll keep our eye on it.

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Weekly Roundup 1.30.15

2015 is already 1/12th over with. Frightening. A winter storm came and went from the East Coast. Here in Washington, we are still waiting for our first serious snowfall and it is not yet on the horizon. We are done taking stock of the year past, and now looking fully forward to the year to come.

And here is a bit of what happened this week of interest, along with a personal note:

  • Esomeprazole Goes GenericFDA announced this week that esomeprazole had been approved by the agency for its first generic version in 20 and 40 milligram doses. Esomeprazole is indicated for the treatment of gastroesophageal reflux disease (GERD). GERD is a highly prevalent condition and according to many studies, possibly increasing. Esomeprazole has been marketed under the brand name Nexium by AstraZeneca. According to the press release from Teva – the company launching the generic – IMS data reveal annual sales at $6 billion as of November 2014.
  • External Defibrillators Get Regulatory Overhaul – Taking steps to improve the overall quality and reliability of external defibrillators, FDA announced this week that it would be requiring manufacturers to undergo a more rigorous review of their product by submitting a premarket approval application (PMA). In its release on the subject, FDA said that between January 2005 and September 2014, the agency had received 72,000 medical device reports related to the failure of the devices and there have been 111 recalls of more than 2,000,000 defibrillator devices. The agency said that it will not enforce the requirement for new devices until July 29, 2016 and for current devices the enforcement target date is January 29, 2020.
  • A New Blog – for the Single Cook - And on a personal note, I have started a new blog if you might be interested. In 1940, just over 7 percent of households were single person homes and by 2012 it was 27 percent – over one quarter. But recipes are written like it is 1940. So, as a single person, I have started a new blog aimed at the single cook called Setting for One. I am not a professional chef or even a great cook, but I do love food and preparing it and so I am sharing what I do in the form of a blog as a sort of “food diary”.  Setting for One is meant to destigmatize the idea of solo food prep and eating and to help individuals see their way to self appreciation through the cultivation of good meals. So if you are inclined, please check out Setting for One. You can see the inaugural posting here.

That’s it for me this week folks. Enjoy your weekend!

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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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