The Convergence of Digital Health, Devices and Pharma

There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace of innovation solely through the lens of policy. Rather, it is due to a number of factors and represents an integration of medical practice that has the potential for significantly changing the way we are medically treated.  Progress in digital technology, communications and medicine are all converging to make a whole new medical care landscape.

For example, what happens when a sensor that one can purchase as a consumer is able to monitor liver function or read the cholesterol level of the wearer? There have been multiple attempts to take statins from prescription status to over-the-counter, allowing consumers to purchase them like allergy medication rather than go to the doctor. But the premise for an over-the-counter switch of medication is that a consumer must be able to take the medication safely without the presence of a learned intermediary (a doctor). Ultimately those switch attempts were not successful because the patient could not monitor liver function or self-diagnose the high cholesterol. The emergence of such a commercially available sensor would change the equation considerably in any new evaluation of a switch.

That is but one, simple example. But the potential for change is quite large and clearly FDA is connecting the dots between technology and medicine. In September, FDA announced approval of a mobile medical application to treat substance abuse, the first time an app would be a prescriptive treatment. Also in September, FDA selected participants for a precertification program for new digital health software. In October, Commissioner Gottlieb issued a statement on new steps to advance medical device innovation as part of the Medical Innovation Access Plan to help patients gain faster access to new technologies and the agency issued a draft guidance on the breakthrough devices program. And in November Gottlieb issued another statement on streamlining development of consumer tests that evaluate genetic health risks. 

The number of apps available in healthcare is prolific. Your phone used to make phone calls, now it takes your blood pressure and reports the readings to your doctor. 

This week FDA announced the approval of an existing prescription medication with a sensor that works to track patient adherence in taking the medication. The sensor works by sending a message to a wearable patch, which then transmits the information to an app on a smart phone that can be monitored by the patient, his/her caregiver and which allows a physician to access the information using a web-based portal. It is a combination not only of the physical – the medication, the sensor, the patch – with the digital, the mobile app, and allowing Internet based monitoring. While prior this treatment involved the ingestion of a pill, it now involves a multi-faceted system. We have entered an age where a medicine may no longer be just a medicine. 

The future belongs to innovation but perhaps those who only innovate in their particular category – device, pharmaceutical or digital app – will have to make room for those who envision the potential for advancement when the different categories are integrated.  And meanwhile, FDA is clearing a path for them.

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Weekly Roundup 11.10.17

Phew – candy handed out and leftovers gobbled up at the office. I am safe. Now comes the rather heavy preparation for Thanksgiving to receive guests and prepare feasts. That, combined with extreme business foreclosed an intermediate posting this week that I had planned, but there is always next week. In the meantime,  it has also been a busy week in all things FDA and here is a bit of what happened this week that I wanted to share. 

Menu Labeling to Proceed (cautiously) – There has been a good deal of back and forth related to the issue of information available on restaurant menus so that consumers can make informed choices about what they eat, with particular regard to the calories being consumed. The agency has been at this a long time, with the first rule for menu labeling proposed in 2011. Let that sink in. This year, another round feedback was received by the agency and now FDA has released a draft guidance that takes into account the feedback received through this long process though it states at the very top that it is non-binding and being issued for comment purposes only. In an accompanying statement, Commissioner Gottlieb states that FDA takes seriously its authority in this regard, but is committed to responsible implementation as well. That appears to include gathering more comment and setting a new date – May 7, 2018, as a potential compliance date. A lot can happen between now and then and in the meantime, we will just have to trust our instincts. 

New Treatment for Rare Blood Cancer – The banner year for cancer approvals – and for approvals for rare diseases – continues with the announced approval of Zelboraf (vemurafenib) as the first medication availble to treat some adult patients with Erdheim-Chester Disease (ECD). ECD is a slow-growing blood cancer originating in the bone marrow that can result in the grown of tumors in many organs and tissues throughout the body.  Zelboraf, a kinase inhibitor, will be used to treat patients with a specific BRAF V600 mutation, which will be just over half of those who have ECD and works by blocking enzymes that promote cell growth. The approval came through priority review and has a breakthrough therapy designation as well as orphan drug status. The company release can be found here

FDA Clears New CBC Test – One of the most common blood tests ordered in a physician office is the complete blood cell count (CBC) helping to assess the health of a patient from a number of perspectives. This week FDA announced approval of a test that can be run in the physician’s office and in other health care centers and performed by a wider range of staff which means faster results meaning not only faster diagnosis but ushering the way for faster access to treatment. Currently such tests are often performed offsite and can take at least 24 hours for results. The approval took place under a regulatory pathway designed to facilitate a streamlined evaluation process. The company press release can be found here

Upcoming Events to Keep an Eye on This Week

  • Senate HELP Committee Hearing – Gene Editing Technology:  Innovation and Impact – On November 14, the committee will hear from three witnesses regarding gene editing technology.
  • Partners in Progress: Cancer Patient Advocates and FDA On November 13 FDA will hold a meeting to provide basic training on the role of the FDA and cancer patient advocates in product development – deemed as most relevant for those with limited knowledge and experience in cancer product development.  
  • Antimicrobial Drugs Advisory CommitteeOn November 16 to discuss NDA for ciprofloxacin inhalation powder for reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) in patients with respiratory bacterial pathogens. 
  • Device Referencing DrugsOn November 16 FDA is holding a public meeting to get input on potential approach for certain device sponsors to get marketing approval for devices that are labeled for use with a drug already on  the market when the sponsor of the drug does not want to pursue the new use. 

Regulatory Developments in Pharma/Biotech/Devices

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Weekly Roundup 11.3.17

We are finally about to Fall Backward!  Don’t forget to set your clock back this weekend to mark the end of Daylight Savings Time as we once again return to dark early evenings and even in December – dark late afternoons. We will maintain sunny dispositions nonetheless, especially those of us with leftover Halloween candy to provide succor.

In the meantime, here is a bit of what happened this week.

  • FDA Warns on Marijuana Claims – This week the agency issued warning letters to four companies for marketing products that contained a cannabiodiol component – derived from a marijuana plant – with therapeutic claims. FDA said in its release (which contains links to the letters) that the companies were selling products online that claimed to prevent, diagnose, treat or even cure cancer. The products came in a variety of forms. In a statement in the release, Commissioner Gottlieb noted that there is a growing interest in developing therapies from components of marijuana, but that such products would need the scrutiny of the FDA approval process, while unsubstantiated claims could steer patients away from products with proven effects.
  • Accelerated Approval for Lymphoma Treatment – The 2017  list of FDA approvals rolls on. This week the agency granted accelerated approval for Calquence (acalabrutinib) with an indication for treatment of adults with mantle cell lymphoma, a particularly aggressive type of cancer,  who have undergone at least one prior therapy. Early trials yielded a high response rate from patients with 80 percent seeing a response and 40 percent achieving a complete response, according to the company press release. The treatment is a kinase inhibitor which blocks an enzyme needed by the cancer to multiply and spread. It represents not only another approval for FDA this year, but another in oncology which has seen a remarkable number of new therapies approved. The compound is also being studied for use in other cancers. 
  • Orphan Drug Tax Credit Repeal Proposed – This week the GOP unveiled a sweeping proposal for tax reform that among other things included a repeal of the tax credit for companies in the development of orphan drugs – those compounds meant to treat conditions that affect fewer than 200,000 people. The purpose of the current structure is to facilitate drug development in areas where companies are not likely to recoup the costs of development because so few people are affected by the condition and has resulted in a marked increase in the number of applications by companies. The credit has had its critics as well. For a good overview, see articles from the Regulatory Affairs Professional Society (RAPS) here and here

That’s it for me this week folks – don’t forget to set your clocks back Saturday night/Sunday morning!

Upcoming Events to Keep an Eye on This Week

  • Partners in Progress: Cancer Patient Advocates and FDA On November 13 FDA will hold a meeting to provide basic training on the role of the FDA and cancer patient advocates in product development – deemed as most relevant for those with limited knowledge and experience in cancer product development.  
  • Antimicrobial Drugs Advisory CommitteeOn November 16 to discuss NDA for ciprofloxacin inhalation powder for reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) in patients with respiratory bacterial pathogens. 
  • Device Referencing DrugsOn November 16 FDA is holding a public meeting to get input on potential approach for certain device sponsors to get marketing approval for devices that are labeled for use with a drug already on  the market when the sponsor of the drug does not want to pursue the new use. 

Regulatory Developments in Pharma/Biotech/Devices

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OPDP Enforcement Letters at Record Low

The Office of Prescription Drug Promotion (OPDP), once known as the Division for Drug Marketing, Advertisting and Communications (DDMAC) monitors company communications about medical products and when it deems those communications have gone outside regulatory parameters, the office issues a letter. For violations it regards as more serious Warning Letters are issued, for those deemed less so it comes in the form of an Untitled Letter. 

In past years, enforcement could be robust. In 1998, for example, 156 letters were issued to companies regarding communications. After declining the following year, in 2000 it took a real dip and by 2002 there were only 28 letters issued. While there was a slight uptick in 2009-10, the rate has continued to decline. The past few years saw 10, 9 and 11 for 2014, 2015 and 2016 respectively. 

By comparison to this year, those are gushers. So far for 2017, OPDP has issued exactly two letters. One Untitled and one Warning Letter. Similarly  OPDP had issued very few letters by this time last year (though more than just two) and then suddenly at the end of the year produced more than they had all year. So it is not yet certain that this year will see virtually no enforcement, but it is looking that way.

Why is it important? As noted many times in past postings on this subject, the letters issued by OPDP serve many purposes, one of which is to provide some insight into FDA’s thinking on current developments in communication in between the lengthy and arduous process of guidance-making. That is an especially relevant purpose in the  context of today’s communications environment that changes quickly compared to the glacial process of policy enunciation by FDA. Case on point of course is the lengthy amount of time that has passed since FDA initiated a process to provide clarity related to social and digital media in 2009, saying guidance would come by 2010 and only providing partial guidance years later in 2014, with several questions still outstanding.Another notable trend over the past years has been that enforcement has tended to focus, though not exclusively, largely on companies that are smaller, less experienced companies in the marketplace.

And so the trickle of visible enforcement raises questions. Why has there been a drop in enforcement activity? Does it represent a shift in emphasis or new policy?  An email sent twice to FDA on the subject went unanswered. 

Perhaps this is a shift to focus enforcement into areas where there is greater risk – that would certainly make sense.  In the past there have been letters issued about violations that might make some scratch their head and wonder about the real element of risk involved. But if that is so, it would certainly make even more sense if the agency were transparent about it and provided some insight into the thinking that is currently going on.

Does it mean that OPDP doesn’t care what is said in highly regulated speech?  I would not count on it. They aren’t down to zero letters. 

Some might be inclined to attribute the drop in enforcement to the change in the U.S. Administration, but the decline began long before. And who knows – perhaps we are still in for a December flurry of activity where several letters may be sent out in a matter of days. Until then, or until the agency chooses to provide some answers, we will be left to wonder. 

 

 

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Weekly Roundup 10.27.17

The leaves are falling around us and still no first frost. And we are just a few short days from the knocks at the door by young and sometimes not so young seeking sugar handouts while dressed in costume. If you don’t have your candy in hand, better run to the store. Before you do – a few things that happened this week:

  • FDA Issues Draft Guidance for “Breakthrough Devices – This week the agency published in the Federal Register a draft guidance to enhance the regulatory approval for breakthrough devices. As with breakthrough status designation for drugs already in existence, FDA is seeking to enhance the approval of devices, however, the status for devices differs from that of drugs in important respects. The particulars of the program as described in the draft guidance are detailed by the Regulatory Affairs Professional Society.  In short, while allowing for an enhanced pathway to approval, it is not a guarantee of faster approval. In addition, Commissioner Gottlieb released a statement respecting the development of a new medical device evaluation tool for use in cardiovascular devices that ties patient output with device development as part of the FDA’s Medical Innovation Access Plan
  • Duchenne Treatment Candidate Gets Complete Response Letter – Last year the agency gave accelerated approval to a drug for use to treat a subset of patients with Duchenne muscular dystrophy and earlier this year another that could be more broadly applied. However, this week in issuing a complete response letter for another candidate treatment – one that would treat patients with Duchenne due to a nonsense mutation in the dystrophin gene, FDA said that the compound needed further evidence of efficacy which reflected some of the input from the FDA Advisory Committee held earlier this year. In a statement, the sponsor has said that an appeal to the decision will be filed. The webcast and meeting minutes from the advisory committee meeting can be found here, though the transcript is not yet posted. 
  • Opioid Public Health Emergency Declared – A long-anticipated announcement by the White House declaring the opioid epidemic a public health emergency was announced this week. The measure opens up the way for government agencies to work to take measures to address the spectrum of complex issues that make up the epidemic, but fell short of the expectations of many to provide new funding for states. Last week in a panel discussion at the Washington Post called Addiction in America, Senators Portman, Hassan and Manchin expressed the hope that the declaration would bring with it additional funding. In addition, Commissioner Gottlieb issued a statement from FDA outlining the steps the agency has been taking on opioids. 

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photograph by Lynne Bertram, Woodstock, Vermont

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