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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Weekly Roundup 3.9.18

Another busy week – tried and failed to squeeze in a posting between the Weekly Roundup, but am well set up for next week. The Northeast had another Nor’easter. And yet here we are once again ready to Spring Ahead and set our clocks for Daylight Savings this weekend on March 11 at 2 AM. Our mornings will be a little less bright, but our evenings will be full of light. 

In fact, it was a busy week at FDA too. And speaking of light, here is what I wanted to shed some on:

  • Commissioner Gottlieb Remarks on Biosimilars Market – This week in a speech delivered before the American Health Insurance Plans’ (AHIP) National Health Policy Conference, Commissioner Gottlieb delivered remarks that for many reasons caught the attention of many and lit up the Twittersphere.  FDA does not regulate price, but in addressing market place conditions that limited access to biosimilars and which he stated disincentivize developers of biosimilars, the matter was one of public health and therefore in the purview of FDA.  He stated that the current economics of biosimilar development are “unstable”. He cited current rebating and contracting practices along with market consolidation as being factors that are undermining the market and in fact, leading some stakeholders to have an incentive to limit update of less expensive biosimilars when they become available meaning that both patients and biosimilar manufacturers. You can see the full text of his remarks here. 
  • FDA Clears First DTC Gene Test for Cancer– It is not only the first DTC genetic test for reporting on cancer mutations, but it is also one aimed at a specific population. This week FDA approved a test that analyzes DNA and produces a report that will indicate that a woman is at increased risk of developing breast and ovarian cancer or if a man is at increased risk of developing prostate cancer. Detecting only three out of the more than 1000 known BRCA1/BRCA2 mutation that increase cancer risk, the test reports on those mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. While providing this information, the test is limited in its applicability, not detecting other mutations that may cause cancer and so a negative test does not rule out the possibility of cancer risk. The test was approved through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate risk devices that are not substantially equivalent to an already legally marketed device. The company press release can be found here
  • More Flu Blues – One item not picked up before publication time from last week was that FDA issued a warning against fraudulent and unapproved flu products that have entered the market during what has been a particularly difficult flu season. The agency reminded the public that there were no OTC approved products that could prevent or reduce the length of tie one suffered from flu. This week in a hearing before the House Energy and Commerce Committee on the topic of flu preparedness, the FDA Commissioner also warned against high hopes with regard to the development of a universal flu vaccine which he said was “many years off”. Instead he outlined the need, and what progress there has been, in moving away from egg-based development of vaccine to cell-based and the steps FDA is taking to facilitate that migration. 

That’s it for me this week folks. Don’t forget to set the clocks and cheat yourselves out of an hour from the weekend. Have a good one!

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

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Weekly Roundup 3.2.18

Spring is definitely springing early. Buds are popping everywhere here in the mid-Atlantic region.  Heck in some places, they are more than buds, they are blossoms. Still, the flu season drags on and this week Commissioner Gottlieb mentioned that it may be with us through April. And a Nor’easter looms ahead with lots of wind. In fact, the federal government closed today due to wind. Have fun with that one – you’re welcome.  

But on to better things – a bit of what happened this week. 

  • Food and Nutrition – There have been a lot of starts and stops connected with food and nutrition following the 2016 election, resulting in an overall lack of clarity and obscurity with respect to intent. This week FDA moved to paint a clearer picture which begins with a newly modified label for food that delineates what sugar has been added from that which occurs naturally and will engage in a consumer education campaign to acclimate people to the new label. In addition, the agency moved on the guidance front.  This includes a final guidance on what can constitute dietary fiber for purposes of being included in labels – specifically to include those synthetic fibers that may have a benefit over those which do not; and a draft guidance applying to added sugars on the label of honey, maple syrup and some cranberry products; final guidance on how to determine appropriate reference amounts for what is an actual serving when used on the label. FDA states that it intends to issue a final rule this Spring on the timing for compliance by manufacturers. 
  • Flu Blues –  In a flu season that has been particularly active, much has been said about the efficacy of this year’s vaccine and this week FDA added to it. The predominant strain – H3N2 – is being studied by the agency to understand why effectiveness tends to be lower when facing this strain, per the statement from FDA Commissioner Gottlieb this week. He stated that they did not believe that the lack of effectiveness was due to a difference in the strains used to manufacture the vaccine from those in actual circulation and that effectiveness with both cell-based and egg-based vaccines was less than optimal. One theory is that this particular strain requires a higher antigen to evoke the appropriate immune response.  On a related note, NIAID announced this week a strategic plan for the development of a universal flu vaccine. 

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

That’s it for me this week folks!  Next week will be Daylight Savings!

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FDA’s Strategic Policy Roadmap, Part 3 – Improving Health Care, Access Issues and Public Health

In the last installment we looked at the first part of the Strategic Roadmap – Addiction which specifically focused on opioids and nicotine. However, the next part of the FDA Strategic Policy Roadmap is less specific and instead is focused on the very broad topics of Improving Health Care Access Issues and Public Health.  That means within this category ends up being a bit of a hodge-podge because just about any enhancements to regulatory oversight would arguably be likely accomplish these rather broad goals.  

  •  Improving Product Development and Strengthening FDA’s Gold Standard 
    • This is sort of what the 21st Century Cures Act was all about – reducing the regulatory burden without compromising safety and that phrase has become a mantra in the many missives from the Commissioner’s office and in FDA as it implements the Act. It also is a carry-over of a campaign theme for this Administration.  That said, the lowering of the regulatory hurdles has been less draconian than otherwise might have been and FDA has been taking a comprehensive, but measured approach;
    • Last year, FDA approved a record number of new molecular entities with 46 medicines getting the thumbs up; 
    • FDA unveiled a plan to eliminate the Orphan Drug designation backlog and announced its success by the Fall of 2017; 
    • Look for how this pans out given the budget proposal made by the Administration which shifts a greater role for user fee generated support for FDA than before and, if that is the way the budget does develop, how that impacts approval times and funding for safety and sentinel activity and programs; 
    • So far this year, FDA has only approved 4 new molecular entities, which would sound like it is off compared to 2017, but in fact by the end of February of last year, the agency had only approved 5 so the agency has lots of time if the pipeline supplies the applications;
  • Promoting Generic Drug Competition
    • Generics are the one area where FDA can impact pricing through its actions – the more generics approved for a treatment, the further down the price is supposed to go and generics account for a huge percentage of the prescriptions written in the U.S. and XX of these approvals involved “firsts” into the market;
    • In June of 2017 FDA published a list of off-patent drugs that did not have generic competition and implemented a new policy to expedite review of generic applications in categories where there are fewer than three generics approved in a category and in January of this year, issued a draft guidance on Good ANDA submission practices to add clarity to the approval process for generics; 
    • The agency also announced that 2017 was a record year for approval of generics;
    • Look for the possibility of FDA to address the perceived “gaming” of the system to delay generic entries in the market – in a blog posting last year, Commissioner Gottlieb alluded to efforts to work with the Federal Trade Commission in identifying and publicizing activities deemed to be anti-competitive and look for guidance documents in the first quarter on aspects of gaming, including potential abuses of the citizen petition process, restricting access to testing samples of branded drugs and abuses of the single, shared system REMS negotiation process;
    • Look also for a concentration on complex generics. 

In the next installment – Empowering Consumers. 

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