What They Said – FDA Press Releases 1st Quarter 2018

FDA has had a lot to say so far this year. A real lot. In fact, during the first three months of 2018, FDA issued 56 press releases, which is as many as they issued during the entire first half of 2017. It is also considerably more than were released during the first quarter of 2016.  If it keeps up at this rate, it is likely that this will be FDA’s most prolific year ever for communicating with the public. 

One of the many hallmarks of the era of Commissioner Gottlieb is the use of the “Statement from the Commissioner…” – as a vehicle to  convey FDA developments. These statements deliver a more in-depth discussion than a regular press release.  They also tend to highlight attention to a particular policy issue and also associate him very closely to the policy developments which are moving on a broad front to address a myriad of issues. During all of 2017, Commissioner Gottlieb issued 35 such statements, but in just the first quarter of this year, he has already done so 26 times (plus 2 others from other FDA officials) – which would annualize to over 100 for the year if they keep up at this rate. It is the volume of these statements that is accountable for the increase in volume of output in press releases.

In fact, as a vehicle, the Commissioner Statement has subsumed the role that press releases from the agency used to play. For example, FDA used to issue press releases about the issuance of new guidance documents. But this quarter, no press releases per se were issued, but rather guidance documents were announced by Commissioner Statements. So in the regular tally, you will now see the total number of such statements, but a subset of them will be parsed out by subject matter as if they were a press release for purposes of tracking subject matter. 

In addition to the bevy of Commissioner Statements, you can see that there have also been a higher number of rules, anticipated rules and guidances announced this first quarter, reflecting the policy push along a number of fronts – from nutrition and labeling to implementation of 21st Century Cures. We can probably continue to look for an increase volume for the balance of the year.

Otherwise, you can see that for approvals we are tracking with last year’s first quarter, though with a higher representation among devices.

But as noted in the beginning, this quarter is the culmination of change that has occurred in the agency – from a communications perspective and beyond. The press release is no longer the end – communicating a particular action of the agency – it has become a means to an end – to demonstrate momentum on the part of the agency overall. And combined with the prolific tweets of the new Commissioner (over 2800 from @SGottliebFDA so far), FDA has embarked on a new era of highly strategic communications.

An update to this report in early July.





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Weekly Roundup 3.30.18

It is hard to believe, but we have completed the first quarter of 2018. Time is flying. Spring is springing. And we are the cusp of the commencement of another election cycle.  It has been another busy week without a posting between Weekly Roundups, but I am aiming to have at least one for next week. The days just whizz by…

In the meantime, here is a bit of what happened this week which might interest you:

  • Pass  (on) the Salt – Gottlieb Talks Food – In a speech given at the National Food Policy Conference held March 29 here in Washington, Dr. Gottlieb gave an outline of how he sees FDA’s role in promoting good health respecting American dietary habits. While there has been progress in both heart disease and cancer in the US, obesity has continued to plague American consumers and he very much linked the public health interest with a governmental role citing a statistic from the American College of Cardiology that over 20 percent of deaths in the U.S. in 2015 were directly attributable to poor dietary factors – some of which he said are by choice and some are due to the conditions in which many must make their food choices. However, he also stressed that consumers want information by which they can make decisions and therefore (as the regulatory of 80 percent of the food supply) FDA was embarking on a comprehensive, multi-year Nutrition Innovation Strategy that builds upon the  Strategic Policy Roadmap laid out by FDA earlier this year. To that end, FDA will be working on labeling issues in particular to (1) modernize claims and help define “healthy” and “natural”; (2) modernizing ingredient labels that are clean, readable and understandable; (3) implementing nutrition facts and menu labeling; (4) modernizing standards of identity, i.e., what it means when a particular term is used to describe a food so that there is a reliable and common frame of reference; (5) reducing sodium content.  In short, it is a comprehensive and far-reaching effort and embodies many aspects which have long been goals, but where execution has been challenged. FDA has opened up a Webpage on the Food Innovation Strategy to follow the progress and developments. 
  • Congressional Research Service Report on REMS and Generics – Under certain conditions, FDA may have drugs to have risk evaluation and mitigation strategies (REMS) which may involve a range of tactics such as the development of a medication guide to patient registries to restrictions on prescribers.  Some stakeholders have expressed concerns that REMS programs have been used by brand name manufacturers to delay the entry of generic competition into the market place and legislation has been introduced in Congress to address that concern. The Congressional Research Service has issued a report – FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development that provides a detailed history of REMS with a focus on the development of same on generic drugs. 
  • First Fully Interoperable Continuous Glucose Monitoring System – It is a mouthful, but it meant something for diabetics this week when FDA authorized marketing for a device that would be the first type of continuous glucose monitoring system that can be utilized as part of an integrated system with other medical devices that may be used in the management of diabetes such as dosing systems, insulin pumps and other electronic devices. In addition, unlike other glucose monitoring systems that were reviewed as class III medical devices, this approval was a class II device approval offering a more streamlined pathway for future devices, which is a big deal according to diabetes friends of mine and will serve to speed innovation and progress significantly – (more “open development of the closed loop” – a funny turn of phrase). And finally, according to the company press release, new device this eliminates the need for fingersticks for calibration or treatment decisions. 

Upcoming Events to Keep an Eye on This Week

  • Congress is not in session, so no hearings
  • No FDA AdComms scheduled for this week
  • No Public Workshops or FDA related meetings

Regulatory Developments in Pharma/Biotech/Devices


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Weekly Roundup 3.23.18

Well Spring happened. Sorta. At least here in the East the first full day of Spring came with a winter storm warning for several inches of snow. Here in Washington, D.C. this coming weekend marks the beginning of the Cherry Blossom Festival. Not sure how it all works out together. Also this week, Congress sat poised on another budget impasse that would result in a partial shutdown with research funding for NIH threatened and then suddenly an agreement that provides a flow of support for important research across a broad number of categories. Spring and winter, blossoms and snow, cuts and funding. 

Sadly another week so busy I did not get to post between Roundups, but that’s the way it goes some weeks. And so here is a bit more of what happened this week:  

  • FDA Trial Program on Clinical Trial Reports Begins – There has long been a push for greater transparency related to clinical trials for the medicines we take. There has been strong advocacy in Europe and a less, but sustained pressure in the U.S. In January, Commissioner Gottlieb announced that FDA would embark on a pilot program designed to increase transparency, if only incrementally, by releasing more information from clinical study reports (CSRs). While some information has been provided through FDA reviewer summaries of data, which provide information but which are “packaged” in a manner that makes it challenging to digest. As part of the pilot program, FDA committed to publishing redacted company-generated CSRs of 9 volunteer companies. This week, in a blog post published by Center for Drug Evaluation and Research (CDER) head Dr. Janet Woodcock, FDA announced the posting of the first of such data. This first publication of data on FDA’s site comes from Janssen Biotech related to the approval of Erleada (apalutamide), the first FDA-approved treatment non-metastatic, castration-resistant prostate cancer. That leaves 8 more companies. Is it enough transparency or just enough?  Time will tell. 
  • House and Senate Pass Spending Bill – FDA saw increases in funding for fiscal year 2018 in the spending bill that cleared the House this week, with a Senate vote scheduled for today. The funding for FDA included an increase in discretionary funding for the agency of $135 million over last year to $2.9 billion and when user fees are added in the total becomes $5.15 billion.  This includes full funding for the Oncology Center for Excellence, additional funding for 21st Century Cures and funding to step up efforts related to the opioid crisis. The House Appropriations release on the funding bill can be found here.  There were also increases for NIH funding and a breakout can be found in this detailed reporting from the good folks at RAPS. The House passed the bill on Thursday and the Senate in the earliest hours of Friday morning.
  • Flavored Tobacco – FDA is changing the tobacco landscape as we have known it. Last week FDA announced steps to make cigarettes less addictive and this week followed up by beginning the process to make tobacco use less attractive, particularly to youth, by addressing the subject of flavored products, including menthol. The agency issued an Advance Notice of Proposed Rulemaking and will seek input from stakeholders regarding the role that flavored tobacco plays in the initiation of tobacco use as well as its ongoing use and impact on cessation. The effort is particularly focused on youth where flavor reportedly plays a role in starting tobacco use in the first place. 

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

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices


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Weekly Roundup 3.16.18

The calendar says that it will be Spring next week, but it did not feel like it to me while working in the cold, windy and rainy garden in the days leading up to this change in season.  However, it has been an interesting week on a number of fronts and here are a few things that I thought we should recap as we close out the week. 

  • A Survey of Professional Prescription Drug Promotion – As part of its ongoing study of promotional efforts, FDA has surveyed healthcare professionals about their opinions related to DTC and promotions aimed at patients. This week FDA announced that it would be conducting a survey of health care professionals to examine issues related to promotional efforts aimed at them specifically given that many health care professionals (HCPs) rely on such information to further their understanding of a particular treatment category and that industry has a wide variety of communications vehicles they employ in that regard. FDA wants to see how HCPs might be influenced in their decisions and practices by promotional materials. Of note, Dr. Gottlieb said in a tweet about the survey that it would include questions specific to opioid products and knowledge about abuse deterrent formulations, regarded by the agency as critical to the agency’s work in countering the opioid abuse and misuse crisis. 
  • Right to Try Fails – The legislation popularly known as “right to try” which was endorsed by the President in the State of the Union message and which has had the enthusiastic support of the Vice President and which has passed in the Senate failed to garner enough votes in the House of Representatives this week. Brought to a vote through a procedure that fast tracked the bill but which required a two-thirds majority, the legislation lacked the votes for passage. The object of the legislation is to give patients greater access to unapproved medications under particular circumstances, but which many argued would give a dangerous bypass of FDA and it was opposed by many patient groups and professionals who you might think would have favored it.  In fact,  over 70 of them submitted a letter  to Congress in opposition. . However, given this is an elected body that made several dozen fruitless resurrected attempts at repealing the Affordable Care Act, it is entirely likely that this issue will be revisited and under circumstances that may be more amenable to eventual passage. 
  • Move to Make Smoking Less Addictive – FDA announced this week that it was issuing an advance notice of proposed rule making (ANPRM) to consider approaches to lowering nicotine levels in cigarettes to minimally or non-addictive levels. The agency is seeking input into process, particularly around questions as to the appropriate maximum level of nicotine that should be present and whether or not new standards should be gradually lowered or not and to identify any potential unintended consequences that may result. FDA anticipates that the lowering of nicotine levels in cigarettes has the potential to help millions of people quit smoking within a short period of time. You can see an overview of the full scope and range of efforts FDA is taking on this issue in reading the Commissioner’s statement located here

That’s it for me this week folks. Have a good weekend – the last of Winter. 

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

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PDUFA Dates, AdComms and Approvals – 2018 So Far

There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), but also for generic approvals (1027).  And among those approvals, there were a number of “firsts” – such as first gene therapy and the first CAR-T therapies. In addition there were a significant number of approvals in oncology. A lot happened last year. That means a lot of eyes turn to this year to see what kind of year it is going to be in 2018. 

So how are we doing?  There are a few places to look when you are making that assessment that are kind of surrogate markers to tell us how things are going. First, of course, there would be the NME approvals. By the end of February this year, FDA had approved only 4 NMEs, which might sound discouraging, but in fact, it is only one less than was approved by the same time last year.  There is still a lot of time for a lot to happen in 2018.

Another place to look is at PDUFA dates, and in doing so there is perhaps reason for cheer. During January and February there were 15 PDUFA dates, 3 of which resulted in Complete Response Letters and 12 of which were approvals, some of which not only occurred early, but very early. At least three of these were approved in December 2017, two months before the PDUFA date. Of the approvals during the first two months, 9 of them were NDAs and 6 were sNDAs. 

And finally, if we take into consideration the activity among advisory committees – last year there was only 1 advisory committee meeting held during the January/February period to consider an NDA for a new drug.  During the entire year by my count there were 23 such meetings.  By contrast, during the January/February time period this year there were 5 advisory committee meetings held to consider NDAs and there have been 10 meetings scheduled so far this year, with more surely to come, particularly with the increase of drugs that have priority review.

Back to PDUFA, for the future, right now by my count, I am currently counting 60 more decision dates for 2018, 41 of which are for NDAs and the balance are sNDAs, and of course, there are more to come.  Five of these involve product NDAs in oncology, two of which FDA have already acted upon away before their actual PDUFA dates.  There are also five in cardiovascular, two in antimicrobial and six in pain.

In short, at this early juncture, judging by a look at these “surrogate endpoints” it would seem that there is a good chance this year will not be a slacker in terms of progress in approvals overall or in advances in major disease areas. 

(The figures on advisory committees and PDUFA dates come from separate databases I maintain on each topic, not from any official sources.)

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