Weekly Roundup 12.15.17

This is it folks, the final stretch. Winter will arrive next week. Travel plans are underway. The last of the gifts are being bought and prepped for the big wrap. And speaking of wrapping up, there are a number of look-backs we’ll be taking in the new year along some specific fronts as the new year begins. But in the meantime, here is a bit of what happened this week:

First “Follow-on” Insulin Approved – In an era where the price of insulin has continued to rise, FDA approved this week the first insulin product approved through the agency’s abbreviated 505(b)(2) pathway which allows a new drug application to rely on the safety and efficacy data of a previously approved product when FDA finds such reliance scientifically justified. The aim of such a pathway is to reduce development costs and thereby introduce products that can be offered at a lower price. The product Admelog, a short-acting insulin to be used to help patients with diabetes control their blood sugar was approved relying in part on data related to Humalog as well as providing its own specific data to establish safety and efficacy. The company press release can be found here

  • FDA Launches New Anti-Smoking Campaign – This week FDA announced the launch of a new campaign against smoking that focuses less on scaring smokers with graphic images and relies more on an understanding that quitting smoking is a process, not an event. The campaign uses messages of support to underscore health benefits that come with dropping smoking sent at various points where there may be triggers that faciliate smoking. Called the “Every Try Counts” campaign it will give smoker pause to re-think a purchase of a pack at point of sale locales. Dr. Gottlieb characterized the overall approach in making “cigarettes minimally or non-addictive, while encouraging the development of potentially less harmful tobacco products…” simultaneously taking new steps to improve access and use of nicotine replacement products to help smokers quit. The campaign complements the agency’s plan for nicotine and tobacco regulation. The website for the campaign can be found here

Upcoming Events to Keep an Eye on This Week

  • Our members of Congress are winding down – no hearings. 
  • No upcoming FDA meetings for the balance of the year and no advisory committee meetings scheduled until 2018.

Regulatory Developments in Pharma/Biotech/Devices 

That’s it for me this week folks. Have a great and safe weekend. 

Photograph by Lynne Bertram

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Weekly Roundup 12.8.17

Given the early arrival of Thanksgiving this year, it should have been a long shopping season, but the walls are already closing in. The days are still growing shorter. The trees and decorations have gone up. We are all in earnest. 

In the meantime, Commissioner Gottlieb continues to make liberal use of special statements issued by FDA, one of which will be the sole focus of the Roundup. Next week I hope to get in an intervening posting as well. 

  • Digital Health Gets Coordinated – This week Commissioner Gottlieb put together a special statement that pulled together focus on all that the agency has been doing to define the digital health space from a regulatory point of view. FDA announced the issuance of three policy documents – two draft guidances and one final – to add more body to the understanding to the agency’s approach. The statement is clearly meant not only to package all that the agency is doing in digital health, and to signal progress under the 21st Century Cures Act, but also to signal to policymakers that FDA is not standing in the way of progress with regulation, but using judicious regulation to enhance progress. In doing so, referencing a starting point with this summer’s Digital Health Innovation Action Plan and the launch of the digital health software pre-certification program, he outlined the three guidance documents.
    • The first – Clinical and Patient Decision Support Software – relies on the tenet that FDA should concentrate its resources on regulating that which has a higher risk associated with it rather than take an across-the-board tack of regulating everything that touches a patient in any capacity. Accordingly for both clinical and patient oriented software programs, FDA will regard as medical devices (and therefore under regulation) only those that process are involved in analyzing or processing clinical aspects of care, such as a blood analysis, while leaving outside the agency’s jurisdiction those that provide information within established clinical guidelines within approved labeling for a drug. In the statement, FDA uses an example software that might trigger a physician to order liver function testing before prescribing a statin. In short, more information oriented software will be outside FDA purview, while functional software with a clinical impact will be inside. 
    • The second draft guidance takes action to clarify the agency’s position on digital health devices that again play a low risk role – such as mobile apps that are intended only for maintaining a healthy lifestyle and not involved in clinical decision-making. Previously FDA had said it would exercise its discretion on enforcement, but with this draft guidance FDA indicates that such devices will fall outside the scope of FDA’s regulation. 
    • Finally, the third guidance is one meant to harmonize the FDA approach to digital health with the agency’s global counterparts to enhance the use of products across borders and is being issued as a final guidance, having been initially issued in October 2016.

The statement closes by saying that the agency is attempting to establish the bright line between what requires and does not require FDA review and regulation. Given that two of these documents are draft, there is time to provide in put into the definition of that bright line. 

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

That’s it for me this week. Have a good weekend and get some shopping done!

Photograph by Lynne Bertram

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Weekly Roundup 12.1.17

Today marks the 30th World AIDS Day. It is at the same time breathtaking and heart breaking to note the progress made during the course of this epidemic. In that first year, there were no treatments for HIV/AIDS, transmission was rampant as were stigma and discrimination. Hope was in very short supply, despair was abundant. Today, millions of people take a combination of any number of therapies that not only keep them from getting sick, but can keep them from infecting others. Treatment is also prevention. Three decades seems at once both short and long for such progress – so many lives being saved today, so many lost yesterday. It is something to consider when thinking of the progress of medicine. 

And here is a bit of what happened in our world not only this week but last week as well (given the Thanksgiving holiday):

  • Spotlight on Nicotine Replacement Therapies – In a joint post to the FDA blog FDA Voice, Commissioner Gottlieb, CDER Head Janet Woodcock and Mitchell Zeller, head of FDA’s Office of Tobacco Products announced the formation of a new steering committee aimed at advancing the science behind FDA’s approach to evaluating the safety and efficacy of new nicotine replacement therapies for smokers who want to quit. The approach appears to be comprehensive in that it could address existing products as well as new ones, with one potential outcome of redefining the endpoints necessary in clinical trials to achieve approval. You can see the entire blog post here .
  • FDA Approves New Opioid Treament – Following the recommendation of an  advisory committee held last month, the agency announced approval yesterday of the first monthly injectable treatment option for opioid use disorder, buprenorphine. The treatment is indicated for patients who have already started a 7 day course of therapy. A once-monthly injectable could increase adherence for some who might be challenged by continuing daily therapy. The label contains a boxed warning for the product. The company press release can be found here.  And pursuant to the posting on Wednesday – Manner of Speaking – in addition to the FDA press release about the approval, the Commissioner issued a separate statement that can be found here where he outlines the agency’s commitment to expanding options for medical treatment for opioid use disorder.
  • An Eye on the Eye – And during Thanksgiving week, FDA approved a new lens indicated for implantation to treat cataracts which can be adjusted post-surgery to improve vision reducing the possible use of glasses in some patients. In the past a patient can experience a need for adjustment after surgery to optimize the outcome of the surgical implant of a lens to address cataracts using either contacts or glasses. The approval of this new product means that such adjustment may occur on the implanted lens after its insertion, potentially foregoing the need for glasses or contact lenses to make the adjustment for some patients. That said, FDA noted that there are a few exclusion factors for patients where it should not be used.  The company press release can be found here.

Upcoming Events to Keep an Eye On

  • Senate HELP Committee HearingImplementation of the 21st Century Cures Act – Progress and Path Forward for Medical Innovation – On December 7 – both Francis Collins from NIH and FDA Commissioner Scott Gottlieb will appear. You can see a copy of testimony from this past week on the same topic before House Energy and Commerce here
  • Bone, Reproductive and Urologic Drugs Advisory Committee MeetingOn December 7, to discuss patient selection criteria and clinical design features for drugs to treat interstitial cystitis and bladder pain syndrome as well as a discussion of the two conditions. 

Regulatory Developments in Pharma/Biotech/Devices

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

Photograph by Lynne Bertram

 

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A Manner of Speaking

During all of last year, FDA issued 18 “general announcements” via press release to discuss agency actions on policy issues, announce a point of view or enunciate a policy issue. Two of those from last year included statements that came from the FDA Commissioner – Robert Califf, as well as one that went out in January of this year while he was still commissioner, totaling three for the time that he was Commissioner. 

By comparison, this year, FDA has so far issued 41 “general announcements” via press release, 23 of which were statements from Commissioner Gottlieb, whose nomination was confirmed in May of this year. It demonstrates a whole new approach to communications by the new head of FDA. That isn’t a bad thing – it accomplishes a few important goals.

First, it displays a commitment to some level of openness about what FDA is doing and why it is doing it. Second, it also demonstrates a commitment to multiple stakeholders that the head of the agency is “hands on” and not leaving matters to others – in short – signaling that he knows what is going on across the wide spectrum of the regulatory charge of the agency he heads. Next the statements allow him to draw emphasis to his point of view for the media on specific topics – to take a hand in shaping any story by providing comment proactively. 

And last, but certainly not least, the Commissioner is putting a big arrow to guide members of Congress, and their staffs, regarding progress the agency is making on multiple fronts. Throughout the confirmation process there were mentions of multiple policy priorities – from addressing the opioid epidemic to pricing to concern about regulatory burden. And perhaps one of the most pressing policy issues – spurring innovation and getting new products to patients – has been a particular priority.

Included among the 23 statements from the  Commissioner were several regarding developments on various aspects of the opioid problem, oversight of stem cell and regenerative therapies, progress on the Hurricane recovery front, efforts of the agency respecting the practice of compounding, getting patient input into FDA work, streamlining development pathways, and announcing a practical approach to menu labeling.  

Both through the combined effect of these pronouncements as well as the individual missives themselves, there is most certainly not only a comprehensive span of issues being addressed, but there is a sense of momentum along all fronts. Grass is not growing under his feet. For a number of reasons, it is good to make others aware of the fact. 

 

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Weekly Roundup 11.17.15

We have no sooner gotten rid of the candy from Halloween then we are preparing to receive our Thanksgiving guests and putting together menus for the big day, only to rush headlong into the next holiday season that will involve a crescendo of preparation!  Our days are darker earlier and soon we shall slow down to a crawl. And in fact, Eye on FDA will be on hiatus until after the Thanksgiving holiday. But before that, here is a bit of what happened this week. 

  • Big Day for Regenerative Therapy – Since in office Scott Gottlieb has announced multiple initiatives aimed at enhancing the development of new therapies – in the past few months in devices – and this week with the issuance of multiple guidance documents –  in regenerative therapies. Two guidances in particular shed light on FDA’s risk-based approach for regulating regenerative therapies, providing categories into which therapies may fall and therefore receive varying degrees of regulatory oversight. In total there are two new guidance documents and two new draft guidances which provide insight into how regenerative approaches can take advantage of a streamlined application process and another on getting expedited reviews. The framework brings clarification on a comprehensive scale. 
  •  First Device for Opioid Withdrawal – FDA announced approval of the first device intended to ease opioid withdrawal symptoms. The device, called the NSS-2 Bridge, is a small electrical nerve stimulator that is placed behind the patient’s ear, emitting stimulative pulses to some cranial nerves to address symptoms of withdrawal such as sweating, gastrointestinal upset, agitation, insomnia and joint pain, and can be work for five days. The approval was based on a single study which showed that all patients had a reduction of symptoms within a half hour of use. Information from the manufacturer can be found here. The approval happens in a week when there was also publication of a head to head study of two medicines approved for opioid addiction treatment. 
  • Two Warnings from FDA – The agency issued two unrelated public safety communications this week. The first was related to the use of silicone injected as a dermal filler for cosmetic purposes (different from approved silicone implants). The agency noted that in some cases industrial grade silicon was being used and said any silicone injections for this purpose, often by unlicensed practitioners, were an unapproved use and could result in serious adverse events. The other public health alert was issued to address concerns related to the use of kratom, a plant being imported and marketed for use in treating anxiety and depression and opioid addiction. The agency warned of very specific risks associated with the use of the plant, including liver toxicity.

Upcoming Events to Keep an Eye On

Next week being Thanksgiving Week, there are no FDA scheduled events and you can bet Members of Congress are not sticking around. Here are a few things thereafter though:

  • Public Meeting on Assessment of FDA Hiring and Retention – On November 30, FDA is holding a public meeting to share findings of a recent assessment on FDA’s hiring process. 
  • Bone, Reproductive and Urologic Drugs Advisory Committee MeetingOn December 7, to discuss patient selection criteria and clinical design features for drugs to treat interstitial cystitis and bladder pain syndrome as well as a discussion of the two conditions. 

Regulatory Developments in Pharma/Biotech/Devices

For US readers – have a wonderful Thanksgiving – everyone else have a great weekend. 

Photograph by Lynne Bertram

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