Weekly Roundup 2.16.18

This week we had 70 degree temperatures and predictions of snow. It seems we are living in roller coaster times – at least for this month. For all the lovers out there, hope the Valentine’s Day was second to none. Here is a bit of what happened in our world this week.

  • Artificial Intelligence (AI) and Stroke – It is said that speed is everything in the wake of a stroke. This week FDA permitted the marketing of clinical decision support software that can alert providers when a stroke may have occurred with a patient. The software analyzes computed tomography results for indicators that a patient may have experienced a stroke and sends a notification to a neurovascular specialist if circumstances indicate a large vessel blockage. The application, which was approved through the De Novo premarket review pathway for new types of devices deemed low to moderate risk and have no legally marketed predicate device as an equivalent, is limited to analyzing data and not intended to be a replacement for a full patient evaluation or relied on solely to make a diagnosis. 
  • Multiple Guidance Docs on Drug Development – This week FDA issued an extraordinary number of guidance and draft guidance documents related to the development of range of drugs related to neurological conditions. This included guidance for Duchenne Muscular Dystrophy, ALS, Early Alzheimer’s, Migraine, and Partial Onset of Seizures. The issuance of the guidance documents was accompanied by a lengthy statement from the Commissioner  that said emphasized the need to modernize drug regulatory programs in the face of the urgent need in these areas. The term “modernize” appears to be emerging as code for removing regulatory hurdles. One of the aspects in modernizing is to speed up the guidance development process – one that has actually often taken years (as we learned on the social media front). On this front, he stated that more guidance documents would be forthcoming noting pointedly one for treatments for opioid dependence and addiction. He also assured that the changes made will also nevertheless maintain scientific integrity in addressing safety and efficacy. You can read an overview this development here at the RAPS site.  
  • Gottlieb Speech on OpioidsDr. Gottlieb delivered remarks at a public workshop on Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids. Comparing the opioid abuse epidemic to a pathogen, he concentrated on providing a concise overview of many of the steps FDA has taken to curb addiction. In addition, he said that FDA was taking a look at the use of gabapentinoids and the off-label prescribing patterns to use this FDA-approved medication as an alternative to opioids and stated that while increased use is not yet perceived as an issue, the agency was looking to see if there was an abuse/misuse problem emerging. In combination with actions taken against other non-opioid compounds in the past weeks, it is demonstrative of FDA’s approach encompassing addressing aspects of the problem from the edges. 

Upcoming Events to Keep an Eye on This Week 

Regulatory Developments in Pharma/Biotech/Devices

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FDA’s Strategic Policy Roadmap – Part 2 Addressing Addiction

With deaths rising each year, there is no question of the urgency that something needs to be done to address the opioid misuse epidemic in the United States. And in addition to mortality there are the lives touched by these deaths, splintering relationships and families, incurring enormous personal and financial cost. 

During his confirmation hearings, the opioid issue was a primary concern expressed among policy makers and Commissioner Gottlieb provided reassurance that it for him a top priority. The Strategic Policy Roadmap released by FDA in January has as its first stated area of concentration to reduce the burden of addiction crises. 

What the Strategic Policy Roadmap Lays Out and What It Might Mean- Addiction is naturally broader than the opioid epidemic, including nicotine addiction as well. The Roadmap begins by addressing opioids but also addresses nicotine related goals. Below are key principles derived from the document issued by FDA followed by notes on what has already been done by the agency under each category as well as thoughts about what might be expected.

  • People are inappropriately prescribed opioid drugs  
  • Durations of prescriptions are often out of sync with need  
    • In a special statement issued this month regarding OTC loperamide, Dr. Gottlieb discussed the use of blister packs to limit exposure in an OTC product and it is not unlikely that such packaging – and limited courses of treatment – be examined for use when there are circumstances where the pain being addressed is short term;
    • Look for the potential development of short-term use packaging options, such as blister packs where the number of pills dispensed is limited and exploration of any other means to limit the number of pills for specific circumstances. This echoed similar statements about packaging made in October 2017. 
  • Conversion of market to use of formulations with deterrence 
    • In late 2017, FDA issued a guidance doc meant to encourage the development of generic opioid medications with deterrent properties;
    • In addition to enhancing entry of deterrent formulations may be shunning those without deterrence away from the market.  In the February 12 Federal Register, FDA published a notice that it was not approving an instant release opioid formulation that lacked deterrent properties.
  • More options are needed to address addiction 
    • First off, FDA specifically states the need to approve more treatment options for addiction and in fact, in November the agency approved the first device with an indication for treating withdrawal symptoms;
    • In addition, in late September 2017 FDA provided an alert to medical providers on minimizing risks associated with medically assisted treatment (MAT) for patients seeking help;
    • Finally late last year, FDA approved the first monthly injectable  (MAT) for opioid use disorder having given the application both Priority Review and Fast Track designations; 
    • Look for a possible education effort to reduce stigma. Part of the Roadmap references the role that stigma might play in reducing access to therapy. This signals possible plans to address the issue through a formalized education effort, perhaps in conjunction with other federal agencies. 
  • Addressing Nicotine Addiction in Combustible Cigarettes
    • Here the Roadmap states that FDA is developing a comprehensive approach to regulating nicotine by regulating nicotine levels to make smoking less addictive. This is one area of the document with very few details on the actual route to achieving this goal. However, in December, FDA did launch a new campaign aimed at smokers called “Every Try Counts” as a print and ad campaign to support those who have tried and failed to quit within the past year. 
  • Helping More Smokers Quit and Stay Quit 
    • The plan states that FDA will take a fresh look at products that can deliver nicotine without burning tobacco. However, a recent advisory committee meeting reviewing a heated (not burning) tobacco product resulted not only in a sobering vote by the committee against recommending the product claims, but a letter from 10 U.S. Senators urging FDA not to approve the products in question. 
    • Look for a series of guidance documents and rules to implement a new framework on nicotine and for the encouragement of medicinal nicotine products that may support people in their efforts to quit smoking.

That’s it for the first arm of the plan. In the next installment, we will take a look at access issues and public health. 

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Weekly Roundup 2.9.18

February. When the inconvenient bursts of weird precipitation, the cold and the dark starts really getting on your nerves. They made it the shortest month for a reason. Facing the prospect of yet another government shutdown, it appeared that at least some members of Congress have come to their senses – and then we had a brief nocturnal shutdown during the night last night. Did anyone notice? And, even though we have short days – and definitely long nights, here is a little bit of what happened regarding our world and FDA. 

  • Generic Approvals Set Record in 2017 – While FDA does not have authority over the pricing of drugs, the approval of new generic versions of brand name drugs does facilitate the drop in price for the category – and the more within a particular category, the more likely the drop is to be significant.  Drug pricing was a major concern raised during the confirmation hearings for Commissioner Gottlieb. That is perhaps one of many reasons then to note that according to a blog posting on FDA Voice, 2017 saw 1,027 new approvals, an increase of 214 over the banner year of 2016. As the blog posting points out, generic drugs comprise 89% of all prescriptions filled in the U.S. and of the approvals, there were 80 that were “firsts” meaning that in those categories, prices would likely come down in the face of generic competition. And if you really want to go in the weeds, you can look at the Office of Generic Drugs Annual Report.  On a related note, there were also five biosimilars approved during 2017, one more than had been approved during the previous two years combined. 
  • FDA Renews Focus on Kratom – FDA Commissioner Gottlieb released a statement this week outlining additional concerns related to the use of Kratom.  It is the second public facing statement FDA has made about Kratom within the last several months and the second time in a week that FDA has focused on a substance that was involved in opioid misuse. (Last week the Commissioner discussed revised packaging to curb potential misuse of OTC loperamide.)  In this extensive communication on Kratom, Commissioner Gottlieb laid out the specifics regarding adverse events associated with this botanical substance, and discussed scientific analysis that demonstrated evidence of underlying opioid properties. The action not only demonstrates that FDA is concentrating on addressing the opioid situation and is addressing it through process, not a single set of events, even willing to nibble at what might be the outer edges of abuse and misuse at times. Neither the loperamide communication nor this stated the scope of the issue being addressed by the action. 
  • Senators Weigh in on FDA Approval Deliberation –  While not able to find  link to the original letter, it was widely reported in media this week that 10 U.S. Senators sent a letter to FDA to weigh in on deliberations in the wake of an advisory committee meeting, also reported here in The Weekly Roundup just two weeks ago. It was a meeting of the Tobacco Products Scientific Advisory Committee regarding claims associated with the heated tobacco product iQOS.  The letter from the Senators, all Democrats, urged FDA to reject the application. It is noteworthy, not just for the fact that it involved 10 Senators, nor that it was about the heated tobacco product, but because in my observation, high profile weigh-in by elected officials in FDA deliberations on product approvals is rare. I have seen members of Congress send letters or statements during open public comment periods of advisory committees, and even seen a Senator and a member of the House show up to provide comment during that session, but those have usually been meetings involving a policy issue, not a product approval. It is worth noting, particularly for those products which have societal issues associated with them coming before advisory committees. 

Upcoming Events to Keep an Eye on This Week

  • Senate HELP Committee – Full Committee HearingImproving Animal Health: Reauthorization of Animal Drug User Fees – February 13, 2018 – Note FDA will be testifying. 
  • Anesthetic and Analgesic Drugs Advisory Committee – On February 14-15, the committee will hold meetings on two topics. On the 14th, it will devote a half day to consider approval of an opioid analgesic in conjunction with the Risk Management Advisory Committee. Thereafter the committee will meet on its own to consider an NDA for a product delivering local analgesia. 

Regulatory Developments in Pharma/Biotech/Devices


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FDA’s 2018 Strategic Policy Roadmap, Part 1

In January, FDA’s Commissioner announced the release of “Health Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap” that provides a detailed overview of priorities for the agency within a relatively short timeframe. FDA and the various centers that make up the agency have long submitted strategic outlines to the public, but they have had a slightly different character. In the document on FDA Strategic Priorities 2014-2018, then Commissioner Margaret Hamburg laid out priorities in broad brushstrokes – Enhancing Oversight of FDA Regulated Products, Improve and Safeguard Access to FDA Regulated Products to Improve Health were two of the goals outlined in that report, for example. 

In the document issued by Commissioner Gottlieb, however, the priority areas of concentration are a little less broad and encompass four categories:

  1. Reducing the burden of addiction crises that are threatening American families;
  2. Leverage innovation and competition to improve healthcare, broaden access and advance public health goals;
  3. Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease; and 
  4. Strengthen FDA’s scientific workforce and its tools for efficient risk management. 

While an outline for the coming year, there is little question that there have already been efforts within each of these priorities, some of which begin to signal for stakeholders in each just where the agency is going and how that is going to impact stakeholder interests. 

Often documents like this are issued and then never heard about again. While that is not likely the case, given the new approach to communications out of FDA this past year, it seemed then like a good idea to begin an occasional series that looks at each of these priorities and tries to shed some light on where we are, where we want to go, and how we are doing at getting there.  We will look at each of the four categories – examine what is being targeted, what has been done and what potentially may be done with some effort at assessing impact on stakeholders. 

The next installment in this series will look a the first priority in some depth, followed by the other 3 in coming posts. 

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Weekly Roundup 2.2.18

Groundhog Day is happening today to bring us the valuable insight related to the length of winter and the beginning of Spring. Exciting, but not as thrilling in my mind as the re-establishment of Daylight Saving Time when the hours of daylight will linger later, to occur in just about six weeks. As we await both events, here is a bit of what went on this week that is of note:  

  • Opioid Crisis Actions – While holding a meeting of the Opioid Policy Steering Committee this week, FDA Commissioner Gottlieb announced an additional step and sent a signal on future direction regarding FDA actions to address the crisis. First, the signal – several times the Commissioner has expressed the goal of having opioid prescriptions that conform to the clinical need and in his communication provided more specifics on how to get there whereby immediate release opioid drugs might be packaged in three or six-day blister packs for short term use in the case, for example, of addressing dental procedure pain. His statement did not outline the pathway to achieving this goal, but clearly there is momentum to limit prescriptions of opioids. And the step taken this week was with respect to OTC loperamide which can be misused in high doses, but safe at recommended doses, requesting changes be made in the label and number packaged for the product. But most specifically the action seemed aimed at online retailers who may sell the product in bulk.  The announcement was another in a long line of individual actions taken to address opioid addiction from FDA. No word on how large a problem OTC loperamide is in the context of the greater issue of opioids. 
  • Presidential Backing on Right to Try – Among other things in the State of the Union address was an endorsement by Trump of legislation popularly known as “Right to Try”.  Passed in the Senate the bill, which would prohibit the Federal government from interfering with state laws allowing patients to access medicines prior to their full testing and approval by FDA, has hit snags in the House. Gaining access to life-saving drugs sooner has long been a goal for patients facing life-threatening illnesses and the HIV/AIDS epidemic served as a catalyst for faster approvals and earlier access. It is not a black and white proposition, there do already exist pathways for early access for patients, and FDA Commissioner Gottlieb has noted in testimony that FDA has approved 99 percent of the applications for such access that the agency has received. For a viewpoint from former AIDS activists and a former FDA CommissionerRight to Try may not be a great idea, check out this op-ed from June 2015.

Upcoming Events to Keep an Eye on This Week

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