Weekly Roundup 8.10.18

The summer creaks onward. In less than a month it will be Labor Day. I don’t know about you, but I find that almost incomprehensible. The folks on Capitol Hill are gone, which makes traffic here almost bearable. We like it that way. You can keep them all home if you like. One note related to the posting last week regarding the increase in the number of Commissioner Statements from FDA – this week there were none!  That hasn’t happened since May. In spite of the quiet, some notable things have happened, so let’s saddle up and round up some news.

  • FDA Approves First DTC App for Prevention of Pregnancy – It is perhaps an historic first for Direct-to-Consumer as well as medical app support as well as contraception that FDA approved today a mobile app to support women in contraception to prevent pregnancy. The app works by providing support in the monitoring of conditions that would signal a likelihood of fertility on certain days – a method of contraception referred to in the FDA release as fertility awareness.  Clinical studies to evaluate the efficacy of the app involved over 15,000 women who used the app for an average of eight months. Remember when you used your phone to make phone calls? 
  • Approval in Non-Hodgkin Lymphoma – Non-Hodgkin lymphoma is a blood cancer that begins in the white blood cells. Two types of disease are Mycosis fungicides (MF) and Sezary syndrome (SS), both rare and difficult to treat. FDA announced approval of Poteligeo, a monoclonal antibody, with an indication to treat both of these types of non-Hodgkin lymphoma for patients with relapsed or refractory forms of MF/SS where there has been a prior systemic treatment . Poteligeo was given Priority Review and had Breakthrough Therapy status as well as Orphan Drug designation. The company press release on the approval can be found here
  • New Generic Regulatory Pathway Sees First FDA Approval – FDA has very limited authority to impact the price of medications through its regulation of the pharmaceutical industry. However, the more generics that are on the market for specific conditions, then the more pricing pressure there is on manufacturers and generally the lower the price will go. With some treatment categories experiencing a lack of available generics, a new Competitive Generic Therapy Designation was put into place to expedite the development and review of a generic drug where there is a lack of competition. This week saw the first approval under that designation with the FDA approval of a generic potassium chloride oral solution for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics.  Ultimately pricing impact will depend on the number of drugs that utilize this category as well as the number of conditions affected. Time will tell. 
  • FDA Expands Valsartan Recall – Back in July, FDA issued a press release announcing a recall involving some valsartan products prescribed for the treatment of high blood pressure. Since that time there have been a number of updates to the initial recall. The focus has been the presence of NDMA in some active pharmaceutical ingredient.  The update from this week includes updated lists of products that are under recall as well as a list of products that are not under the recall. Both lists can be accessed in the most recent update. FDA is continuing its investigation and will provide further updates. 

Things to Keep an Eye on This Week

  • No hearings
  • No AdComms
  • No FDA meetings
  • It’s August…..

Regulatory Developments in Pharma/Biotech/Devices


Photo by Jez Timms on Unsplash

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Weekly Roundup 8.3.18

This week’s posting about FDA Communications resulted in a nice story by Ed Silverman over at STAT and some Twitter action from the Commissioner about the role of the “Statement from FDA Commissioner” missives that I wrote about. Fun stuff.  – On other fronts, as mentioned last week, I have been a little out of commission due to some personal things, but am back with my eye on things. Here is a bit of what I thought noteworthy from this week.

  • REMS Review – Dr. Gottlieb remarked via a statement  on the meeting (held August 3) of the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would be meeting to review the assessments of REMS programs, which were first approved in 2011, related to the use of transmucosal immediate release fentanyl (TIRF) products. The end goal is to determine whether or not adjustments to the elements of the program are necessary.  The statement reaffirms the often expressed aim to strike a balance between the need for appropriate access versus potential for abuse. One focus of the meeting, he said, will be not only an examination of the data, but the accuracy of data, related to prescriptions of TIRF medications for patients who are non-opioid tolerant. For those interested not only in the issue of appropriate use of opioids for pain control, and the issue of misuse, but also those interested in how such data is accurately harvested, it should be an interesting meeting. 
  • Warning in Women’s Health – Another statement from the Commissioner this week focused on a warning issued by the agency regarding the use of devices for “vaginal reconstruction” to treat conditions related to menopause, sexual function and urinary incontinence.  The agency said that energy-based devices – commonly referred to as radiofrequency or laser – which have approval for specific conditions have been marketed for a non-approved use under the heading of vaginal reconstruction. The agency issued the warning for women and their doctors and notified seven manufacturers regarding the inappropriate marketing of devices. 
  • House Energy and Commerce Letter to Opioid Manufacturers – This week the House Energy and Commerce Subcommittee on Oversight and Investigations sent a letter to three manufacturers of opioid products.  The committee site excerpts from the letters states “For more than a year, the Committee has been investigating the potential breakdowns in the controlled substances supply chain which may have contributed to the nation’s opioid epidemic. Pharmaceutical manufacturers play a unique and critical role in this supply chain by researching and developing products for the consumer market as well as marketing such products after obtaining approval from the Food and Drug Administration (FDA)”. In short, the letters are seeking information, and pose a series of questions, aimed at gaining insight into marketing practices and awareness of misuse. 

Things to Keep an Eye on This Week

  • Senate not in session. 
  • August 7 – Antimicrobial Drugs Advisory Committee – meeting to consider NDA for amikacin liposome inhalation suspension for proposed indication of mycobacterial lung disease. 

Regulatory Developments in Pharma/Biotech/Devices

Photo this week by me!


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What They Said – FDA Press Releases 2d Quarter 2018

A personal note – Apologies – I have been lagging on postings following a bereavement. 

As each quarter ends, it has been an Eye on FDA practice to look back and compare different types of activities to assess any changes or trends from FDA over the course of time. Today we’re going to look at the press releases for the first half of the year and at each quarter specifically, compared to the same time periods from last year.

If your own intuition has led you to think that the public is hearing more from FDA than they used to, then rest assured that you’d be right. The level of communication emanating from FDA is up dramatically over last year and over the first quarter.  And the Commissioner is leading the way. 

First of all, let’s look at the first half of the year. During the first six months of 2017, FDA issued 52 press releases, but for the same period this year, it more than doubled to 126 releases.  

During the first quarter of 2017, FDA issued 23 releases and then saw a slight increase in the second quarter to 29. But in 2018, the number of releases issued the first quarter was 56 (more than double the same quarter the year before) and in the second quarter, that number increased to 70. That means that so far this year, not only has the overall number of releases increased, but so has the velocity. 

What are they talking about – what leads to the increase? In the update on the first quarter of 2018, it was noted that the increase in the number of “Statements from the Commissioner” was the reason behind the spike. Such statements prior to the Gottlieb area were rare as hen’s teeth. Today they are exceedingly common and they are generally, though not always, employed to provide a depth beyond the issuance of a press release – to provide history and context around policy and to demonstrate progress – and to provide a personal stamp on agency developments by the Commissioner. 

Here is a close up look comparing the first quarter of this year to last, and a comparison of the first 6 months of 2018 to the same period for 2017.

  • Approvals – You will note that while the total number approvals are slightly up for 2018 (32) over 2017 (30), drug approvals were actually down slightly (22 in first half of 2017 versus 19 in first half of 2018), while device approvals have gone up. 
  • Legal Actions – Another big difference between last year and this was the increase in the number of announcements related to a legal action – a warning or consent decree – related in large part to actions the agency has been taking vis a vis kratom, e-cigarettes and opioid-related products. 
  • Scott Speaks – Finally, the biggest change of all – Commissioner Statements.  In the first half of 2017 there were 7 releases in the catch-all category of “General Announcements”, 4 of which were Commissioner Statements. In the first half of 2018, there were a whopping 72 General Announcements, 53 of which were Commissioner Statements, which is something like a 1200 percent increase. What does he talk about?  Everything. He provides deeper background than exists in a press release about things the agency is doing – from the legal warnings on e-cigarettes to the reasoning behind new guidance documents and the policy implications of FDA actions, which may be announced in press releases, to provide context. 

As noted in the report from last quarter, communications at FDA has definitely changed – there is more of it, and it is more in-depth. And the Commissioner is front and center as a driver. 

Photo by G. Crescoli on Unsplash





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Weekly Roundup 7.13.18

Happy Friday the 13th, one of two for this year. Don’t worry, the other one happened already in April. I have been out on vacay for a bit, along with many I think. But back at the grind now and have some stuff coming up for you next week looking back at the first six months of FDA activity from a few perspectives. Congress is back from vacay as well, so things are on the upswing here in D.C., at least for a while. Here is a bit of what happened this week.

  • OPDP is on a Roll!  Talk about vacations – after a long dormancy, this week FDA’s Office of Prescription Drug Promotion (OPDP) issued its third regulatory action letter this year, and the second for June. Like many others in the recent past, this one was for promotion of an unapproved drug.  That means that 8 of the last 18 regulatory action letters issued by OPDP were issued about this violation, indicating that it is an area that will still move OPDP to act. The communications vehicles in question were an exhibit booth and a website. The compound is being studied for use in treating AML, but FDA said that the communications involved statements and presentations that made conclusions about safety and efficacy, using language to represent that the drug has a role in the treatment of AML.  This letter was an untitled letter, as were the other two for this year – so far no Warning Letters. But just a reminder from OPDP, low enforcement does not mean no enforcement.
  • Balancing Access to Pain Meds with Addressing Abuse – The line is not entirely clear. FDA has taken some meaningful actions to address abuse potential and some that might be considered questionable. This week there was an effort to provide an update and some context when the Commissioner issued a statement regarding access for patients in need of pain control with the need to take steps to stem abuse. While mentioning that FDA was holding a meeting with patients experiencing chronic pain in one of the agency’s Patient Focused Drug Development meetings and looking ways to innovate the development of devices that may treat pain, little was said in this statement about actual efforts being taken now to assure access for legitimate patients while a good deal of it was focused on avenues to misuse. In the end, to this reader, there was a lack in balance in the statement itself, much less the approach being taken. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Andreas Dress on Unsplash

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Weekly Roundup 6.29.18

Apologies are in order for the interruption in the Weekly Roundup schedule and no postings the last few Fridays. It was partially inspired by the fact that it was a busy  few weeks for me.  Conversely it seemed not so much for FDA despite the issuance of a number of not-so-interesting statements so it seemed a good idea to forego a few Roundup postings.  Things got more newsworthy this week though and hopefully makes up for it.  Included are a few things from weeks gone by.  Next week no posting for July 4, resuming the week thereafter. 

  • OPDP Issues 2nd Letter of the Year!  Just when you think FDA’s OPDP is on permanent vacation, they surprise you. The office of the FDA in charge of promotional enforcement which used to issue dozens and dozens of letters to companies each year has eeked out its second for this year. This one was not a warning, but an untitled letter, and the subject was a video for a product that has a boxed warning on its label. Yet FDA found the video contained absolutely no risk information. The video depicted an interaction between a physician and a patient whereby the patient expressed a speedy and breezy use of the product, which FDA also maintained was not an outcome that was typical for patients who might use the product. You can see the letter here
  • FDA Issues Guidance Clarifying Economic Discussions with Payers – In my last posting I covered new FDA Guidance related to discussions about useful drug information not contained in the label, but nevertheless consistent with the label. A companion guidance also covers discussions with payers and formulary committees about economic information not contained in the label to support decision-making around reimbursement. The audiences for this information include both public and private sectors, formulary committees, drug information centers, technology assessment committees, pharmacy benefit managers, third party administrators and other multidisciplinary entities that make coverage decisions. For approved drugs the information imparted must pertain only to approved labeling. The guidance covers situations where manufacturers are providing healthcare economic information (HCEI) to providers about approved drug products, medical devices as well as unapproved products, and the guidance divides the discussion under those categories. 
  • FDA Approves First Medicine Derived from Marijuana – You would have to live under a rock not to have heard this news, but it is historically significant enough for a number of reasons to mention here. First, the newly approved drug, Epidiolex, a purified form of cannabidiol (CBD) and one of more than 80 active chemicals found in marijuana. The new approval, which lacks the THC component for achieving a “high”, is indicated to treat seizures as a result of Dravet Syndrome and Lennox Gestaut Syndrome (LGS).  Both conditions affect children.  It is the first approval for a drug to treat Dravet. Both conditions can have a dramatic impact on quality of life for those affected and their families. But significance is also derived from the fact that the source material – marijuana – has long been advocated as a potential source of medicine. The study for potential benefits has long been hampered by legal constraints and by dogma but FDA has provided guidance for the clinical study of botanicals. The approval was under Fast Track, Priority Review and the drug has Orphan Drug Status. You can see the FDA press release here, the statement by the Commissioner on the importance of research in this area here and the company press release here
  • More on Patient Input – For a long time now we have heard about FDA transitioning to be more patient-centric, including the development and launch of a Patient Engagement Advisory Committee as well as holding a series of Patient Focused Drug Development meetings covering more than 20 disease areas. And in 2016, patient experience counted in the approval of a drug contrary to the recommendation of an FDA Advisory Committee. This week the agency issued a draft guidance document, the first of four planned, to explain to both patients and drug developers the principles by which FDA will incorporate patient and caregiver experience into the regulatory process. This particular guidance – Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – concentrates on providing methodologies for how to operationalize the collection and use of patient experience data by drug developers. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by zelle duda on Unsplash

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