FDA and The Scarlet Letter

FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block the development of generic drugs. There is no doubt that the arc of progress favors greater transparency on many levels in many areas. This may or may not be one of them. 

In the media there has been some question as to whether or not this is “shaming”  pharmaceutical companies who have refused samples to those seeking to develop generic competition. It raises some important questions. Just a few, for example, is publication of the names of these companies an effective means of deterring this delay?  Is it needed? And is publication of a one-sided allegation advisable?

Is it effective?  Time will of course tell. But a lot of information gets published on the FDA website that is unpleasant. If a manufacturer does not meet current good manufacturing processes, they are sent a letter from FDA demanding compliance. The letter and the damaging information are there for all to see.  Does that action deter manufacturers to the point that compliance is enhanced?  One could argue it does, but nevertheless, the letters are still issued on a regular basis. And before FDA’s Office of Prescription Drug Promotion dramatically slowed down its enforcement to a trickle, letters were also published on the FDA site that cited regulatory violations for what the agency considered inappropriate promotion. So the idea of publishing violations on the FDA site is not new. Is it a deterrent? FDA’s OPDP seems to have given up. Meanwhile violations of good manufacturing practices still occur. Would there be more if the letters were not published?  We don’t know.

Is it needed?  FDA has cited a number of complaints regarding manufacturers who have not provided samples. But are the letters aimed at many or a few manufacturers? Do they involve many or a few products?  It isn’t entirely clear. That said, FDA has said there are 150 such letters – reportedly impacting about 50 brands. And still last year FDA approved over 1000 generic drugs – a record year. The year before that – at 813 – was a record year as well. So while there may be some bumps in the road with some manufacturers, the numbers indicate a healthy pipeline of generics and 50 is not a very large number in comparison. So it is logical to ask the question, is this a solution in search of a problem?

Is it advisable?  That invites lengthy discourse. Obviously FDA thinks so. But what is being provided is one-sided story. A manufacturer submits one side of the story. FDA publishes it. But is a manufacturer going to be permitted to submit and publish their rationale for delay?  Are there circumstances that might justify a point of view for delay?  Moreover, does this really address the issue of pricing. Yes, the more generics that exist, the more prices come down. But is this addressing the issue of pharmaceutical pricing on a broad scale, or is it a nibble at the issue from the edge?  Generics, after all, come on to the market when a patent has expired. The most expensive drugs that are on the market often, though not always, tend to be those which have been newly approved. This may address a part of the pricing issue, but actually it would appear to be a relatively small part. 

President Trump this week gave a speech this week on pharmaceutical pricing that followed a campaign alleging that industry was “getting away with murder” that was accompanied by a blueprint entitled “Putting Patients First“. But the blueprint – which implies a plan – while many pages was long on ideas and short on action. After the speech, pharma industry stocks shot up. And for those advocates demanding action, the plan was more like Putting Patience First. As a first step out of the starting gate, publication of these letters is a small and incremental effort and yet as the first, it is going to get a lot of attention. But as to the substance, it is painting the pharmaceutical industry with a broad brush stroke when generic approvals have been at record levels and it certainly does not go to the heart of the matter of pricing. 

Photo by Larry Costales on Unsplash

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Posted in FDA Policy, Generic Drugs | 1 Comment

Weekly Roundup 5.11.18

Soon school will be out, rush hour will be less hectic, vacations long planned will be taken. Pollen counts are high and thunderstorms threaten to materialize nearly every other day. Washington is moving at high speed though the gravity of politics outweighs that of policy by far. In the meantime, here is some of what happened this week and some to look forward to next week in this Weekly Roundup. 

  • FDA Moves on Stem Cell Clinics  – The agency announced this week that it was seeking permanent injunctions against two stem cell clinics marketing unapproved stem cell products to patients – one in Florida and one in California. FDA found that the clinics were offering treatment for a wide variety of conditions including Parkinson’s disease, AML, COPD, cystic fibrosis among others. FDA is seeking permanent injunctions against the clinics. Stem cell operations offering hope to patients with life-threatening conditions are not a new phenomenon. And the number of practitioners is high – as evidenced in this 2016 survey  published in Cell Stem Cell. While FDA’s action is aimed at only two, it begs the larger question about the operations of many other clinics in the U.S. 
  • Non-surgical Device for GI Bleeds Approved – FDA approved a non-surgical treatment for upper (esophagus, stomach and small intestine) and lower (large intestine and rectum) bleeds of the gastrointestinal tract the agency announced this week. The treatment is an aerosolized spray delivered during an endoscopic procedure and is not intended for use in all kinds of bleeds, including for patients with bleeds derived from large veins developed as a result of conditions such as alcoholic liver disease. The spray is a device that was approved under FDA’s De Novo pathway, a risk-based classification for devices without a predicate device already on the market and which is regarded to present low to moderate risk. The company release can be found here
  • More Action on e-Liquids – Following up on prior action against marketers, FDA this week announced four new warning letters aimed at manufacturers selling “e-liquids” – that which goes into an e-cigarette and contains nicotine – in a way that makes the product resemble products designed for children such as soda, cereal and pancakes. In addition one of the manufacturers was cited for selling such products directly to minors. In the announcement about the action, FDA made the point that apart from presenting a danger to minors, such marketing techniques undermine the legitimate potential role for e-cigarettes to support tobacco cessation by adults. It was unclear from the release if this action is part of a continuing string designed to inhibit such marketing practices or if the letters of the past two weeks are meant to address the entire scope of the problem. The manufacturers have 15 days to respond to the warning letters. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Jarren Simmons on Unsplash

 

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Pharma, FDA and Web Site Mobilization

In 2009 FDA set up the framework outlining its approach to regulating promotional speech by pharmaceutical companies by posing five questions for discussion during a two-day public meeting the agency held in Washington, D.C.  Rather than issue a single guidance document that outlined responses to those questions, what followed many years later were a few guidance documents specific to digital platforms – one on correcting third party misinformation and one on use of platforms with character space limitations. And in the course of addressing broader topics, there were other guidance documents that encompassed digital as well. An overview of FDA social media actions can be found on a tab set up on the blog site here

With respect to character space limitations, the guidance document provided examples of branded communications where space would be limited – one for ostensibly for a platform like twitter and one for an online advertisement.  There was no mention of creating a web site for mobile viewing on a small screen. 

One of the few areas that provides any insight into the advance-regulatory thinking of FDA’s Office of Prescription Drug Promotion (OPDP) is looking at the research it conducts. In 2017 FDA completed a research project that analyzed promotional content regarding prescription drugs on mobile devices – i.e., tablets and phones, which was published in the Journal of Medical Internet Research (JMIR) in April of 2017. That effort examined 51 mobile communications that were DTC.  The study had a particular emphasis on looking at the presentation of benefit and risks with regard to presence, place and prominence. Of these 51 advertisements, 35 of them linked to branded web sites. Of those sites, the researchers found multiple approaches to presenting risk and benefit information.  

While fully trusting the research I engaged in a bit of my own that differed from the methodology used in the OPDP research and simplifying it greatly with perhaps a related, but different objective. I merely wanted to examine the approaches with respect to the landing pages of branded sites (not the advertisement that leads people there). I took a list of 20 top-selling drugs and visited their branded websites using my phone and my iPad. I looked to see if indication was mentioned on the landing page and how the risk information was positioned.

What I found indeed confirms the conclusions of the OPDP research – the approach is not uniform, though it does cover the bases. Unlike the last time I did a check on top-selling pharma branded sites, this time all of the ones I looked at were mobile sites, readable in the small screen. But the approach in design was often different. Many, for example, did not mention an indication on the landing page – leaving you to either click on prescribing information or scroll to find it. Likewise, risk information is often either click or scroll. And it happens in different combinations. Some with indication on landing and risk on scroll, others with risk on landing and indication on scroll or click. In other words, any lack of stated FDA preference or guidance has meant that different approaches are being taken. It is a little mystifying why OPDP would conduct research to discover what common sense would bear out. 

For many, access to the Internet is actually reliant on online access via smart phones, and in particular, this is true for younger Americans, non-whites and lower income individuals, according to a Pew Research Center Fact Sheet dated February 2018

It is not entirely clear how interested FDA is in this topic. While they have put some effort at research on the issue, a regulatory approach to this does not merit a decade of thought. Perhaps they are just taking the “risk-based approach” and assessing that any risk here is negligible, which would be hard to argue with. But if that is not the case, lacking any standards from the agency, companies will do the best they can. That is likely sufficient from a patient safety point of view, but at some point the agency could decide that a single approach is necessary. When that happens, everyone else will be wrong. 

 

Photo by Lauren Mancke on Unsplash

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Weekly Roundup 5.4.18

It is apparently May. Hard to believe. It is that time of year when one day you have the furnace on because it is so chilly and the herbs you just planted on the last warm day are threatened with frost, and then two days later, you flip on the air-conditioning because it is over 90 and the dog is panting. It is good to have variety in life.  c

And here is some of the variety from the week I thought I’d share in the Weekly Roundup. 

  • Commissioner Speaks at FDLI, OPDP Does Not – Commissioner Gottlieb delivered the key note address at the Food and Drug Law Institute Conference held this week in Washington. While leading with reference to upcoming action on opioids and prescribing, in a move that got a lot of attention, he then focused on drug pricing, referencing the upcoming (and postponed) presidential speech on the topic. While pricing is not normally considered FDA subject matter jurisdiction, he referenced taking on the system of rebates between payers and manufacturers directly by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute and he stated that “the framework the Secretary (Azar) has developed will dismantle many of the provisions that shield parts of the drug industry from more vigorous competition. This perhaps signals that the presidential speech on the topic will be substantive, or at least we are to anticipate it as such. On an unrelated note, the Office of Prescription Drug Promotion (OPDP) which has traditionally given an overview of enforcement was not a presenter on the agenda for the conference. OPDP has issued only a single regulatory action letter so far this year. 
  • FDA/FTC Action on e-Liquids to Kids – I had to look up the term “e-Liquid”.  This week FDA and FTC announced that the agencies jointly sent Warning Letters to 13 manufacturers for packaging e-liquid products – the stuff that goes into e-cigarettes and contains nicotine – to resemble products that are healthy for kids, such as apple juice boxes and other packaging that would resemble products desirable for young people. In addition for deceptive marketing, the agencies cited some of the manufacturers for selling the products to minors. In the letters the agencies directed the manufacturers to review the packaging and respond with corrective measures.
  • FDA Kicks the Food Can Down the Road – The agency published a notice in the Federal Register announcing that it was going to delay new food labels for another 1.5 years.  Despite the fact that the final rule was published in May 2016, FDA has stated that manufacturers need more time to consider technical aspects. In an “FDA in brief” issued by the agency, Commissioner Gottlieb stated that “It’s crucial that we provide clear expectations so that industry can meet them. It’s just as important for consumers to be able to effectively use the updated food labels, and we’re launching a major educational campaign for consumers to help them understand the new nutrition information that they’ll be seeing in the marketplace.” No mention in the brief as to the nature of the technical aspects that required the extra time. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Lee Pigott on Unsplash

 

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Treating the Patient, Not the Symptoms – FDA and Digital Health

Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy.

He began his talk by saying that for most of the last century, medical practitioners “generally treated the individual as a collection of symptoms, rather than treating the patient as an individual.” Patient-centricity has long been a goal of those seeking to reform healthcare on a number of levels – from improving the quality of care and reducing medical error to delivering care that is specific for each patient, rather than taking a disease-centric approach. By their very nature, digital health tools are themselves so focused on the particular patient that they are key to making that transition to a very different way of practicing medicine in the 21st Century.

Today digital health is often a picture of two extremes. Either we have our hand on the elephant and can describe that spot very well, but fail to see the entire picture.  We may take our blood pressure using a device that is connected to our phone and sends the results to our doctor, for example. Or the opposite occurs and the entire picture is described in such a way that it sounds like a lot more like hope than reality – offering the world of tomorrow, but today. In his remarks, Dr. Gottlieb managed to straddle these extremes and evoke a very comprehensive picture of where we are, where we are going, and what FDA is doing to get us there. 

FDA has recently approved several new innovations that are representative of the way that digital health is producing a new approach to diagnosis and treatment, and he cited the fact that FDA had authorized 51 new digital health products in 2017. For example, last year FDA approved a drug for schizophrenia in which an embedded sensor would allow for the sharing of information with the patient’s provider through a medical app. And this year, FDA approved what he termed “a type of clinical decision support software” using artificial intelligence in the diagnosis of stroke. Also this year, FDA approved a medical device combining AI with a special camera to detect diabetic retinopathy in diabetics in the primary care setting. In short, digital health is migrating from outside the physican’s office to inside. The ability of digital health to detect and to impact both the timing and depth of the information flow greatly enhance a growing role for individuality in approaches to treatment.

To facilitate that he said that the agency with oversight of this space must become as nimble as the technology that is being regulated. And to that end, he outlined four primary undertakings by the agency:

  1. Expanding the pre-market review of digital health tools as medical devices through the pre-cert program, providing the roadmap to the development of the Pre-Cert 1.0 which he stated will be ready by the end of 2018 and refined in the following year;
  2. Implementing a new approach to the review of artificial intelligence – applying the pre-cert program to AI in a way that will allow manufacturers to make device changes without re-submission and he foresees a time when AI can be incorporated directly into smart phones or wearable devices;
  3. Integration of digital tools to the work FDA is doing itself with the use of a new premarket digital safety program that will employ a digital submission process that will facilitate safety reports and data sets that are more readily analyzed, and
  4. Development of a new digital health incubator at FDA – called INFORMED with a focus to advance analytics in oncology. 

There is more to the speech.  He stated that FDA will be opening a public docket to get input on how to apply digital health to the drug development process. In his remarks he sent a clear message not only about the scope and pace of change that digital health brings to medical care, but also with respect to the agency that regulates it. 

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