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

Photo by Shane Rounce on Unsplash


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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!

Photo by Stijn te Strake on Unsplash

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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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When Public Policy and Medical Science Are Misaligned

Two announcements last week were in startling contrast. One was a scientific development that moves the needle forward, the other a policy announcement that tries to pull it back. 

The first development came from Google AI researchers and a published study using a retina scan to assess an individual’s for cardiovascular risk. While still to be validated and done in a larger test population, the study demonstrated that by examining a persons retina, artificial intelligence could apply algorithms that could make determinations about whether or not a person might have high blood pressure or be a candidate for heart attack or stroke. The development of the AI ability still has a way to go, but it is huge development in offering a diagnostic capability that is quick, painless and does not involve drawing and testing blood. It is likely to get better, one would think. It is also part of an overall trend in healthcare – i.e., to simplify the collection and use of data to not only treat patients, but to educate them about their own status. Technology, digital health and artificial intelligence stand to deliver more information into the hands of patients than ever before. The consequence of that will achieve a public health priority – making people aware of their potential medical risks so that they can perhaps avoid or mitigate them through treatment or modification of the status quo. So you are at risk for cardiovascular disease, weight loss might avert the possibility.

But when you engage in a diagnostic screening, you have documented that you may be pre-disposed to a specific condition. Should you develop the condition, if you are insured with a plan that is not required to cover pre-existing conditions, when you then seek treatment for it it could be maintained that you were a person with a pre-existing condition and the treatment would not be covered by your insurance.  Fortunately, under the Affordable Care Act, people are not excluded from coverage for a pre-existing condition. 

That brings us to the second development. This week Health and Human Services announced a proposed rule that would allow greater leeway for the purchase of short-term healthcare plans. These are plans which do not meet the standards for insurance laid out in the Affordable Care Act – standards which include provision for coverage for pre-existing conditions.  Under the current structure, a person may purchase such a plan for a short-term period of three months, under the proposed rule it would expand to twelve months. If it becomes the new norm, assuming people take them up on it, the insurance that is purchased may not cover individuals who have raised their hand by taking a screening test, whether it be Google AI or any other, to assess their risk.  Screening potentially becomes a marker for discrimination if one’s insurance policy by insurance in  is not required to cover pre-existing condition. 

The first development opens the door to expand the options for people in assessing their risk for serious conditions, and perhaps avoiding it through effective prevention efforts. But the second development stands in potential misalignment to that objective. As we are on the cusp of an entire new era in self-monitoring and risk identification, the politics being played out in the healthcare debate may in fact discourage the use and uptake either of the new technologies, or the new insurance option. In the end, we will have to ask ourselves whether public policy should be so mixed with politics that the advancements we make in our medical care are to be undermined by our political scrambling. 

Photo by Heng Films on Unsplash


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Weekly Roundup 3.23.18

At least here in the mid-Atlantic region, the ground hog appears to have got it wrong, with a week that had quite moderate temperatures. In the herb garden, the chives have popped up, always a harbinger of Spring. I tried to get in a posting this week, but being a short one the week got away from me.  It was a short week in a short month and things have moved a bit slower. Even the FDA blog – FDA Voices – has not been updated since February 7.

Still, all that said, things still occur here is a bit of what happened this week that caught my eye, but like the week and month, will be short:

  • OPDP Issues First Letter of 2018 – The Office of Prescription Drug Promotion, which last year issued only a total of 5 regulatory action letters, eeked out their first for 2018. Given the enormous focus on opioids by FDA in the past year, it comes as perhaps little surprise that the product involved was an opioid. The communications vehicle was an Exhibit Panel and the violation – only one cited – had to do with supplying incomplete risk information as well as there being issues of placement. Apart from being the first, the letter is significant because it (1) demonstrates that despite the massive slowdown last year in enforcement there nevertheless continues to be activity vis a vis promotion of products and (2) that being the subject of so much scrutiny in this environment, the makers of pain killers and in particular opioid products should take extra care in the presentation of promotional language, especially regarding risk. 
  • The Destruction of Kratom – Sounds like a SciFi novel doesn’t it?  This week FDA announced the voluntary recall and destruction of supplies of the herbal supplement known as Kratom. Earlier in the month, FDA Commissioner Gottlieb released a statement regarding  a scientific examination of Kratom asserting that there were opioid compounds present in Kratom.  The effort included product under three brand names distributed by one company, but did not say whether there are other brands from other companies still that might be on the market.  And in a related development, the Centers for Disease Control also announced an multi-state outbreak of salmonella possibly associated with Kratom. The outbreak to date is reported to have caused 28 cases in 20 states and resulted in 11 hospitalizations. 
  • The Flu Season and FDA– By all reports, it has been a particularly difficult flu season with the vaccine that had been available this year apparently dipping in terms of its efficacy. Commissioner Gottlieb issued a long statement that details FDA’s involvement in the development of a vaccine each year and notes that the advisory committee meeting that will consider what strains go into the mix for the next season will be occurring  shortly – in fact on March 1. He also states that while the development a universal vaccine would be ideal, that it is also something that is likely many years away from reality. 

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

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

Photo by Frantisek Duris on Unsplash

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