Weekly Roundup 10.19.18

Fall is in the air, election ads are on the air – it is definitely October, the time of trick or treat. Mums and pumpkins have replaced summer stock on front porches and in yards. Thanksgiving foods are on display in the grocery – lots of cinnamon, eggnog and cans of pumpkin. I even saw cranberries on display. And on the more official front, most certainly the biggest news of the week was the surprise activity in  enforcement out of OPDP noted in yesterday’s posting which most certainly adds some more specific definition into the current approach which has been lacking for a long time.

Otherwise it was a bit slower on the FDA side of things. Even the FDA Commissioner only issued a single statement. In any case, here is a bit else of what happened:

  • Commissioner Marks Progress and Issues New Draft Guidances – The one statement the Commissioner did issue this week was noteworthy in that he cited the progress that the agency has made in not only getting new products approved, but promoting targeted therapies. He noted that with two months still to go, FDA was only one drug shy of hitting last year’s record number of new approvals. The occasion for the statement was the issuance of two new  guidance documents. The first was a draft guidance – Hematologic Malignancies: Regulatory Considerations for Minimal Residual Disease in Development of Drug and Biological Products for Treatment and the second a final guidance – Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease – which would be a fancy way of saying helping to find gene variants that cause disease in smaller groups of patients. The statement is noteworthy not only because of the number of drugs approved for this year heading to a record, but because it is part of a larger body of activity that would appear to be turning the giant ship that is known as FDA. 
  • FDA Provides Additional Contour to DTC and Product Labeling – In addition to the actions noted in yesterday’s posting regarding DTC and enforcement , there was some further contour to the issue of product labeling and product promotion provided in speech given this week by the FDA Chief of Staff before the Food and Drug Law Institute on October 16. In it, toward the end of the speech, she laid out some additional particulars on the studies that FDA will be conducting related to product promotion as well as the issuance of a new guidance  – Presenting Quantitative Efficacy and Risk Information in DTC Promotional Labeling and Advertisements – designed to help better translate the sometimes complex results from clinical trials into something that is meaningful and understandable by patients and consumers. The draft guidance provides concrete examples and given the fact that the conveyance of risk information is the most frequent violation cited by the Office of Prescription Drug Promotion in regulatory action letters issued, those who are involved in communications promoting medicines should take a look carefully. The draft covers several promotional mediums – print, electronic, audiovisual and broadcast.

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices/Food

Photo by Annie Spratt on Unsplash

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Speaking of Communications – OPDP on the Move

Over the past few years, regulatory action letters from FDA’s Office of Prescription Drug Promotion (OPDP), while once plentiful, has been something of a rare occurrence. In response to questions on the matter, FDA was often vague. This week however, OPDP was on the move in ways worth noting, issuing not one, but two regulatory action letters and announcing plans for some study of direct-to-consumer advertising. Together with recently reported comments from FDA, the letters bring into sharper focus the picture of of the current enforcement approach by the agency than there has been for a while. 

First, the letters. These were only the fifth and sixth letters of the year. The first was a Warning Letter (as opposed to Untitled Letters). 

In the first letter posted this week, the communications vehicle involved was a Facebook page, making it the third letter in the long history of OPDP to involve that particular social media platform. The product, inhaled insulin for the treatment of diabetes, comes with a boxed warning. The violation was the most common violation of any – the presentation of risk information. The fact that the violation occurred via Facebook communications is actually not relevant, but that it was digital is. When FDA set up a framework for considering how it would regulate social media in November 2009, the framework involved specific questions for which the agency was looking for input and one of them was the appropriate use of links. However, no specific guidance has been forthcoming on that topic. That said, for a long time, it has been clear through enforcement actions that risk information cannot be incorporated by reference (or link) and must be present when viewing the benefit information. In this case, the Facebook posting in question talked about taking insulin with “no drama” and referred the viewer to a page for full prescribing information on the one hand, and had a pop-up when the cursor hovered over the logo on the posting, but the agency stated that is not adequate. 

The second letter was an Untitled Letter and was unusual in that the communications vehicle involved the words spoken by a sales representative. Of the 329 letters in my data base of warning/untitled letters, this is only the 14th involving an oral statement.  FDA was citing language made by the sales representative during a presentation that it said promoted a product for a use for which it was not approved and in addition, minimized the risks associated with the use of the product, which also came with a boxed warning. 

Recently Dr. Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research, was quoted as saying that the agency was taking a more cautious approach to enforcement in light of First Amendment issues and was focusing on situations where there might be an important safety concern. 

That said, low enforcement obviously does not mean no enforcement. While different circumstances, both of the letters involved products with boxed warnings. In fact, of the six letters issued this year all but one involved a product with a boxed warning. It is notable also that both involved reports of violations made to FDA through the Bad Ads program, whereby healthcare professionals are encouraged to report violations. 

And aside from letters, OPDP also published intent to conduct some specific studies related to promotional aspects of medicines and direct-to-consumer advertising. One of the studies aims to examine the presence, wording and prominence of disclosure information related to products granted accelerated approval. In the second announcement, OPDP signaled it will be studying disease awareness and prescription drug promotion on television. The agency says that it is interested in seeing “whether and to what extent” the practice of engaging in disease awareness in relation to a product results “in consumers confusing or otherwise misinterpreting the different information and claims presented”. 

Those in healthcare communications around medical products should sit up and take note this week. While OPDP has been less active on the enforcement front, the letters this week demonstrate that when the agency receives complaints via the Bad Ad program, it will act on them, particularly where, as Dr. Woodcock indicated, it believes there is a safety issue – which may be more pronounced when a product has a boxed warning. 

Photo by Goh Rhy Yan on Unsplash


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HHS Proposes Pricing in DTC

In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list price of a drug in direct-to-consumer (DTC) advertisements for the product. Yesterday Health and Human Services (HHS) proposed a rule that would require just that for drugs that are reimbursed under Medicare or Medicaid. Much has and will be written on this idea. Here is some more.

Presumably the motivation for requiring the naming of the Wholesale Acquisition Cost (WAC) is that in doing so, manufacturers will be inclined to lower the cost of drugs given their appearance in such ads. Critics are dubious. The Food and Drug Administration is a highly evidence-based organization and in fact, today announced several studies on the impact of various aspects of DTC and its ability to inform or misinform viewers. (See here, here and here). In relationship to the proposed inclusion of pricing in DTC, no evidence has been put forward to demonstrate why this rationale might be sound, nor was any study announced. 

There is a lot for an interested viewer to pay attention to during the viewing of a DTC ad. There is information about the condition being treated, there is information about the benefits of taking the drug, about the risks associated with the taking of the drug for the condition, about who should be taking the drug and who should not, and about how it is administered. Adding a new element, the WAC which is one of the numbers associated with the price of the drug, but is not likely to be the actual cost to the patient, which is what the patient actually cares about adds a new element, but it does beg the question whether or not it will have the intended effect. 

When consumers get a prescription, they are often accompanied by medication guides – lengthy documents that explain a good deal of detail about the risks and benefits of the drug. A patient may read them once, or more likely to skim them, but not read them every time. The point is that providing information alone does not mean that the information will have the intended consequence.

The rule states that it is proposed so that consumers can make an “informed decision”. Further the proposed rule states that “[c]onsumers price shop when looking to purchase a new car, a new house, or even a new coffee maker”. But the price of a drug to a patient is not the same as the price of a cup of coffee maker. One can go to many places for the maker and shop and compare and make an informed decision about what you are paying for. However, when it comes to medicine it is an entirely different motivation for purchase. One needs a specific medicine to address a very specific need. Realities of need prevail over those of cost and a price label that is not directly relevant to what is actually paid by the patient may not inform, but merely confuse. 

There have been many proposals to address pricing, some of which may be more effective than others. Here relaying a price of a compound, without the context of what the consumer actually will pay out-of-pocket, in the pecking order of information that is contained in a drug ad, may likely have little consequence on the consumer/patient. The rule makes the case for the WAC as a valid indicator, but it is a speculative case. Ultimately if listing the WAC does not have an impact on patients, why should it have an impact on the manufacturer? At the very least, it could be a matter of study.

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Weekly Roundup 10.12.18

Winds of change, and literal winds, swirled this week. And autumn has finally arrived to Washington, D.C. Before you know it, we will be giving thanks at our tables and gearing up for to accomplish our frenzied holiday shopping. But for now, the weekend has arrived and it is time to look back at a bit of what happened – and I absolutely promise to bet some intervening postings this coming week. On the whole, it was a bit of a quiet week, but here are a few things of note. 

  • CDRH Publishes Guidance Agenda – Each year the guidance agenda gets published by the principle centers responsible for regulatory development in biologics, drugs and devices. CDRH this week posted its list in three sections – (1) those draft and final guidances it intends to put out; (2) those that it would like to put out and (3) those which it would like to revisit. In any case, the lists are aspirational and does not represent absolutes. That said, this has been a big era for devices – a category which includes not only genetically based tests, but apps and software-based medical support. In short, devices are undergoing rapid change. Among those final guidances FDA intends to issue were ones regarding the Breakthrough Devices Program, Expansion of the 510(k) program, Multiple Function Device Products and Clinical and Patient Decision Support Software. Among those drafts FDA aims to issue include one on Patient Engagement in Clinical Trials and Computer Software Assurance for Manufacturing. An accompanying blog posting by CDRH Director Dr. Jeff Shuren can be found here

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices/Food

Photo by Annie Spratt on Unsplash

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Weekly Roundup 10.5.18

Back from vacay in the middle of the week (and wishing I were still gone), I returned to find it was a comparatively quiet week on the whole, at least in our corner of the world around the workings of FDA. That said, there are a few things I wanted to note not only because they are big important issues, but really are demonstrative of the broad arc of change that is being constructed at FDA and which follow long-stated themes of the Commissioner. They are both, particularly the one regarding digital health, also representative of very complex issues where it is important to follow the incremental process or one can lose the thread entirely. 

  • Citizen’s Petitions and Gaming the Generics Approval Process – FDA Commissioner Gottlieb issued a statement this week on a subject that has been a theme for him when it comes to actions FDA can take to impact pricing. Generic approvals, which have been occurring at record rates in the past few years, are considered a primary means for FDA to participate in efforts to impact the price of medicines. The Commissioner has frequently used the phrase “gaming the process” to refer to tactics that might be employed to delay the entry of generics to the market – one of them being the filing of citizen’s petitions which though they rarely result in delaying market entry, do take up agency resources in the review. He announced the issuance of a revised draft guidance to describe the process by which FDA will consider a citizen’s petition to assess whether it has been filed for the purpose of delaying approval of a generic application. 
  • Gottlieb Update on Digital Health Regulation – As digital health devices and software rapidly advance, the Commissioner revisited the issue this week in a blog posting on FDA Voice – and because the area is not only evolving, but has many layers to it, getting periodic updates, overviews and explanations is not a bad idea. The premise is that FDA’s traditional approach to medical device regulation isn’t going to work in this era of software and sensor development that allow consumers to gather more data about themselves that may be medically useful. He distinguishes between the need to review a medical app and a review of the entire device upon which it sits. Further, when there is a need for review – as in the case of an app intended for a medical purpose – the agency is offering a review program designed to reduce the time taken. Finally, he notes that the agency will be seeking additional resources in the FY2019 budget to create a Center of Excellence of Digital Health to advance the pre-certification model that is now being put together by FDA that will include, among other things, a cybersecurity unit. 
  • FDA Clears First Hearing Aid to be Controlled by the User – The Bose Hearing Aid was cleared for marketing by FDA, a device that provides the user with control over both the fit and functionality of the hearing aid. A hearing aid user can adjust the hearing aid through the use of a mobile app from a smart phone, allowing for changes in real time by the user. FDA noted that the agency is in the process of drafting proposed regulations that would create a new OTC category of hearing aids. The device was reviewed under FDA’s de novo premarket review pathway designed for devices that are considered moderate risk devices that are novel and for which there is no prior legally marketed device. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices/Food

Photo by Andy Kelly on Unsplash



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