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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Weekly Roundup 9.28.18

Greetings to you from Cape Cod. A little vacay time. And it was a good time to get out of Washington, D.C. as you may have noticed. Lots happening, challenging to any other news that might emerge during this time.  Still, there may not have been dramatic televised daytime hearings, but some things did happen in our corner of the world and here are a few of them.

  • Gottlieb Opens Flu Season – The flu season started this week and FDA Commissioner Gottlieb issued one of his many statements on the topic – and in fact, I know of some people who began the season early. He noted that the flu virus is a vaccination challenge given that the viruses can not only change from season to season, but during the season and that while during last year’s flu season there were less than optimal experiences with the efficacy of last year’s vaccine in the face of a season that had a high level of severity, it is nevertheless important (he got his flu shot for this year). Last year, for example, the strains identified for the vaccine were correct, but some changes in the makeup of the strains over time caused the vaccine to be less effective than in years past. He believes that there have been updates to the scientific approach taken to address these changes that reduce the chances of a repeat of last year’s issues. He dove into an extraordinary amount of detail regarding how flu vaccines are manufactured, but his bottom line is that vaccination remains the square root of effective flu season preparation. 
  • FDA New Draft Guidance on Adaptive Designs – FDA this week brought out two draft guidance documents designed to facilitate the development of clinical trials that examine multiple drugs for multiple issues and therefore establish principles moving forward more quickly than can be accomplished through a singular and sequential model of study.In FDA’s statement on the guidelines, Dr. Gottlieb stated that improving the approaches to drug development in this manner could speed up the discovery and development of new therapies, not only getting them into the hands of physicians and patients more quickly, but creating an environment with a greater potential for competition of compounds thereby bringing prices – as well as the cost of development – down. The two drafts “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biosimilars” and “Adaptive Designs for Clinical Trials of Drugs and Biologics” were reported in the Federal Register and more can be seen in that publication here and here regarding the docket that is being opened offering the opportunity for public comment.
  • NSCLC Approval – In the past few years, there have been a number of advances in oncology, both blood-based cancers and solid tumors, reflected in the large number of approvals that have come through. This week FDA approved a new first-line oral, once daily treatment – a kinase inhibitor – for Non-Small Cell Lung Cancer (NSCLC) with three unique biomarker properties. Vizimpro (dacomitinib), per the company press release, the FDA had granted a priority review. 
  • DEA Re-Schedules Epilepsy Treatment Derived from Marijuna Plant– In 2015, legislation was signed into law that set a timeframe for the Drug Enforcement Agency to take action on scheduling drugs that had been approved by FDA. This week DEA issued an order for scheduling a recently FDA approved plant-derived cannabidiol  treatment for epilepsy listing it under Schedule V which is the lowest restriction level, meaning there is a proven medical use and a low abuse potential. The re-scheduling affects only one FDA-approved treatment and per the company release, all other non-FDA approved cannabidiol treatments are in Schedule 1. The company said  in its release that with the completion of the label, it hopes to make the medicine available in six weeks. 

Things to Keep and Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Anna Sullivan on Unsplash

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Weekly Roundup 9.21.18

It has been a tumultuous few weeks. Despite my best intentions, there were no intervening posts from the last Roundup to this and last week’s had to be skipped due to lack of time. But trust me, I’m working on it.  The busy-ness just hasn’t let up and I have been on the run – so this week I will cover more than usual and go back a bit as well. 

  • E-Cigs and Kids – Well the big news this week as well as last involved FDA actions to stem the rising tide of use among teens. It began when last week the agency issued a press release and the Commissioner issued a statement, outlining regulatory steps that were being taken against both retailers and manufacturers. The agency said that it was the largest coordinated enforcement action taken in FDA’s history, missing more than 1,300 warning letters and fines to retailers involved in the illegal sale of e-cigarette products to minors. In addition, there were 12 letters issued to other online retailers who continued to market products that resembled kid-friendly food products. In an interview on the PBS News Hour, Dr. Gottlieb stated that in addition, FDA was taking action vis a vis the flavored products by having manufacturers submit documentation that these products provide a net public health benefit, and further that “all options were on the table. With e-cigarette use among teen skyrocketing, FDA also announced “The Real Cost” Youth E-Cigarette Prevention Campaign to educate youths that vaping is not a risk free activity. 
  • FDA Completes REMS Guidance for Opioids – The final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) was approved this week by FDA, including for the first time immediate-release opioid medicines used in the outpatient setting. The program requires that training be made available to health care providers – including nurses and pharmacists – who are involved in the management of patients with pain, though according to the release, there is no federal requirement that makes the training mandatory. Since 2012, education has been part of the REMS for extended release and long-acting products, but immediate-release opioids account for 90 percent of all opioid pain medications prescribed for outpatient use. The action expands the REMS coverage from 62 products to 347. 
  • FDA to Enhance Review of Low-Risk Medical Devices by Third Parties – The agency has taken many steps to facilitate the faster review of new products across the board, steps that have included enhanced review cycles, for example. And concentrating agency efforts on areas that present the greatest risk has been an on-going effort for some time. Last week FDA announced that it was going to put forth a framework to “better leverage reviews provided by experts in FDA-recognized third party review organizations” that would be equivalent in quality to FDA’s own type of review. The plan is for the agency to expend less time and effort on low-risk devices by accepting outside review for submissions that are eligible. FDA will review the recommendations of third parties and then make a final decision, but “generally will not review the submission itself.” The plan can be found here. The draft guidance can be found here. The news of the plan was released through an FDA in Brief notice

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech and Devices

Photo by Lee Pigott on Unsplash


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