Mark S. Senak's Blog, page 11

Weekly Roundup 11.2.18

We are shifting gears as we head into the year’s end, with two months to wrap everything up and we kick it off by ending Daylight Saving 2018 this weekend – so remember to set your clocks back (Fall Back) this weekend. In the meantime, it was a week of long days and travel for me, precluding some intervening postings. That said, several things happened on the FDA front and here are a few of them:

FDA Approves New Opioid – If you wondered whether or not it would be possible for another opioid medicine to be approved in the current climate, today FDA provided an answer. In his statement regarding the approval of the AcelRx compound Dsuvia (sufentanil sublingual tablet 30 mcg) for the management of acute pain severe enough to require an opioid analgesic in adult patients in certified medically supervised healthcare settings, Commissioner Gottlieb stated that in balancing the needs of pain patients with the risk considerations of the category, it is important to consider whether “new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.” He described the unique approach taken with this particular opioid – that it is restricted in its use to certified medically supervised health care settings such as hospitals and administered by a health care professional using a pre-filled, disposable, single-dose applicator delivering the dose under the tongue. He stated that in addition to weighing each drug application on the merits of the individual drug, that in the case of opioids, FDA will use its new authorities with regard to post-marketing decisions and to require unit dose packaging and dispensing systems. He also cited, but did not limit himself, to the consideration of key questions in evaluating a new entry to this market – here in paraphrased form – (1) does an additional opioid benefit public health due to its properties; (2) does it create aded risk of diversion or misuse or other concerns; and (3) is there differentiation that will benefit certain groups of patients?  His statement is lengthy and worth the read. 


OPDP Issues 7th Letter of the Year – After spending most of the year in regulatory slumber, the Office of Prescription Drug Promotion (OPDP) seems to be using this last quarter to play catch-up. This one was a Warning Letter, the second of the year, and involved two products (one for the treatment of schizophrenia and one for sleep/wake disorder) but only one communications vehicle – a web page. Earlier this year, the head of CDER, Dr. Janet Woodcock indicated that the agency would likely be reserving enforcement for violations that were the most egregious. What might that mean?  In this case, it means a web page regarding a medicine that has a Boxed Warning, but which contained no risk information whatsoever. It its noteworthy that nearly all of the letters issued this year involved products with Boxed Warnings. The number of regulatory action letters for this year now surpasses last year’s low of five letters issued, but falls far short of the eleven from 2016. However in that year, OPDP issued six of them in the month of December – so given the recent spate of letters, let’s keep our eyes open.  And if you are involved in communications for a product with a Boxed Warning, be alert.


Recall of Test Strips to Monitor Blood Thinner Levels – It has not been a good year for cardio patients. First the recall of a major blood pressure medication and now a Class 1 recall announced for test strips used to monitor levels of warfarin in the blood stream for patients with blood clots at-home or in the doctor’s office. According to the FDA release there are millions of Americans who take warfarin to thin their blood, prescribed for patients who have certain types of irregular heartbeats, blood clots or who may have certain implant devices. FDA warned patients that they should not rely on the results of the tests from certain lots of the strips issued during 2018 and stated that use of the strips can result in serious errors in medication dosage as a result that could bring serious harm to patients using them. The agency stated that they are working with the company to ensure swift removal and replacement with corrected strips as soon as possible. 

Things to Keep an Eye on This Week

November 9 – Due Date for Response of Commissioner Gottlieb to Letter from Senators Warren, Murray and Smith 
November 8 – FDA Oncology Center of Excellence – Society for Immunotherapy of Cancer Public Workshop – Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials

Regulatory Developments in Pharma/Biotech/Devices/Food

Findings from FDA Investigation into Romaine Lettuce E-Coli Outbreak
FDA Issues Draft Guidance on Use of Dried Plasma Products in Transfusion
FDA Permits Marketing of 2 Devices That Detect Parahyperthyroid Tissue Real Time During Surgery

 

Photo by Annie Spratt on Unsplash

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Weekly Roundup 10.26.18

A Nor’easter heads to the Nor’east. Autumn colors are appearing a bit tardy and a bit

muted. There are many little people in costumes. And already Christmas decor can be spotted in shops, to which one must turn a blind eye. Life goes fast enough.  And the week went fast enough for me, including an 18-hour day yesterday, that meant no postings this week between Weekly Roundups, but we’ll aim for something better next week. In the meantime, here is a bit that happened worth noting:

Gottlieb and the New Opioid Legislation – This week new legislation was signed into law – the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) – and Dr. Gottlieb took the opportunity to issue a statement to review the steps FDA has taken over the past 18 months with respect to confronting the crisis. He also took note of the new tools that the legislation provides across several domains,  He noted that the agency would gain enforcement capacity with new authorities to stop illegal and unapproved drugs from entering the country through international mail facilities, allowing the agency to expand its efforts in those centers. In addition the agency will be able to prohibit future importation by any entity convicted of illegal importation of drugs. FDA gained authority to issue a mandatory recall for any controlled substance if there is a reasonable probability of a serious adverse health consequence, as opposed to the previous mechanism invoking voluntary recalls. In addition, FDA will be able to require specific packaging of opioids and other abuse/overdose related compounds that may discourage longer durations of use as well as enabling the agency to require mail-back return pouches for unused medications. Finally, the legislation will support FDA’s efforts at developing evidence-based guidelines as well as supporting the development of alternatives to opioids to address pain. A one-page summary of the bill can be found here, and a section by section summary here. 


FDA Allows Marketing of Menopausal Test – The agency announced this week that it had permitted the marketing of a Elisa diagnostic test that would serve as an aid in determining a patient’s menopausal status that could in turn result in prompt discussions about preventive care for women experiencing symptoms. That would include ways to prevent bone loss and approaches to address cardiovascular disease. The test measures the level of a hormone that serves as one indicator to assess whether a woman is approaching her final menstrual period, and is used in conjunction with other clinical assessments, unspecified in the FDA release. The test was reviewed through the de novo premarket review pathway for low-to-moderate-risk devices of a new type. The company press release can be found here. 

Things to Keep an Eye on This Week

October 29 – FDA Public Workshop – Clinical Trials to Optimize Outcomes in Early Breast Cancer
November 1 – Joint Meeting of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee – Consideration of NDA for treatment for major depressive disorder
November 2 – Meeting of Psychopharmacologic Drugs Advisory Committee – Consideration of NDA for treatment of post partum depression 

Regulatory Developments in Pharma/Biotech/Devices/Food

FDA updates valsartan recall list
FDA approves new drug for treatment of influenza

 

 

Photo by Daniel Tomlinson on Unsplash

 

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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

October 22 – FDA Science Advisory Board Meeting – CVM’s Antibiotic Resistance Monitoring System
October 23 – FDA Workshop – Data Integrity in Global Clinical Trials – Are We There Yet? 

Regulatory Developments in Pharma/Biotech/Devices/Food

FDA takes steps to improve mammography quality
FDA issues draft guidance on premarket submissions on cybersecurity in devices
Administration announces “Winning on Reducing Food Waste” initiative

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.

Photo by NeONBRAND on Unsplash

 

 

 

 

 

 

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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. 


Guidance on Generics of Complex Drugs – As FDA is winding up another banner year with respect to generic approvals, the agency is acting to further facilitate generic development. Commissioner Gottlieb issued a statement this week announcing a series of new guidance documents aimed at development of generic transdermal and topical delivery systems (TDS) which are applied to a patients’ skin to deliver drug into and through it. The new guidances are Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs and Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, along with two new product-specific guidance documents and 23 revised ones. The Commissioner signaled in his statement that the agency will follow up with even more policies to promote generic competition for complex drugs as well as other measures to address legal questions blocking generic development. 

Things to Keep an Eye on This Week

October 17 – FDA Oncology Center of Excellence Public Workshop – Sickle Cell Disease Clinical Endpoints
October 17 – Joint Meeting of Gastrointestinal Drugs Advisory Committee with Drug Safety and Risk Management Advisory Committee – Consideration of sNDA for IBS Treatment
October 18 – Gastrointestinal Drugs Advisory Committee – Consideration of NDA for treatment of chronic idiopathic constipation

Regulatory Developments in Pharma/Biotech/Devices/Food

FDA Clears DNA-Based blood compatibility test 
Close AdComm vote on pain NDA
FDA Issues Safety Communication on Cybersecurity of implantable cardiac devices

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

October 10 – Oncologic Drugs Advisory Committee Meeting – Consideration of bio similar for treatment of NHL
October 11 – Anesthetic and Analgesic Drug Products Advisory Committee – Consideration of candidate for treatment of moderate to severe pain in adults where intravenous opioid is warranted

Regulatory Developments in Pharma/Biotech/Devices/Food

Results from FDA’s Pesticide Monitoring Report on residues in foods

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

October 3 – Senate HELP Committee, Subcommittee on Children and Families – Hearing – Rare Diseases: Expediting Treatments for Patients
October 3 – Vaccines and Related Biological Products Advisory Committee Meeting – 2019 Influenza Vaccine Strains

Regulatory Developments in Pharma/Biotech/Devices

FDA issues draft guidance on Special 510(k) program
Lilly gets approval of migraine prevention treatment
FDA Re-classifies and Re-names “Female Condom”
Once daily oral treatment for NSCLC approved

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

September 25 – Senate HELP Committee Subcommittee on Primary Health and Retirement Security -Hearing – Health Care in Rural America: Examining Experiences and Cost 
September 27 – Senate HELP Committee Hearing – Reducing Health Care Costs: Improving Affordability Through Innovation
September 27 – House Energy and Commerce Committee, Subcommirtee on Health Hearing – Better Data and Better Outcomes: Reducing Maternal Mortality in the U.S. 
September 27-28 – Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender (Dr. Gottlieb giving keynote)

Regulatory Developments in Pharma/Biotech and Devices

FDA approves device for treatment of acute coronary artery perforations
FDA approves new treatment for hairy cell leukemia
NIH launches study to test combination antibody treatments in HIV
FDA issues guidance on heparin containing devices and combination products

Photo by Lee Pigott on Unsplash

 

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Weekly Roundup 9.7.18

BAM!  Traffic has returned. So have we all from the beach or the mountains or somewhere in between. Back-to and First-Day-of-school pictures have dominated Facebook postings. A promise has been extended by weather folks that the high  temperatures and humidity will both drop. Hurricanes have begun spinning their way across the Atlantic – and in political news. I took last week off for the end of summer and a birthday and so this week will incorporate a few things that happened from last week. And next week there will be postings between the Weekly Roundups as we get back to a more normal routine. So here is a bit of what happened. 

OPDP Issues Fourth Letter of the Year – Yes, the rest of us were on vacation, but the eerily quiet Office of Prescription Drug Promotion (OPDP) was not and the agency posted the fourth letter of the year that had been sent out mid-month. The letter was an Untitled Letter and as has become the near-norm, it went to a company that you would not find in the top-50 list of companies in terms of size. The product in question is indicated for treatment of moderate to severe vasomotor symptoms and moderate to severe vulvar and vaginal atrophy due to menopause and was a topical gel that came with a boxed warning on the label, but the agency made no mention of risk in the violation portion of the letter. The communications vehicle in question was a “sell sheet” that contained language that the product represented the treatment with the “lowest effective dose” for the indicated uses when FDA said that this was not the case. You can see the letter and sell sheet here. Unsubstantiated claims are a relatively rare violation.


Sweet Spot on Sugar – Finding the best way to design the nutrition label on the food we purchase is the product of a long and negotiated effort. This week FDA Commissioner Scott Gottlieb issued a statement to discuss the treatment of “added sugars” and what that means. He stated that while the old version of the label listed only the total grams of sugar without distinguishing between naturally occurring sugars and those that are added to the product, the new final rule does and includes not only sugar, but honey and maple syrup among others, noting that added sugars can contribute more than 10 percent of a person’s daily calorie intake. The new label will not only note the added sugar, but will include an added daily value for added sugar for the consumer to make assessments. However that may be confusing when the product is a single ingredient product such as syrup or honey. For those type of products then as of now FDA is suggesting the label include extra information to clarify any reference to “added sugar” to be included in a sort of footnote so as not to confuse consumers. FDA anticipates issuing the final guidance by January 2020. 


Compounding (Again) – The agency announced that it was issuing a revised draft of the Memorandum of Understanding (MOU) between FDA and the states to address outstanding issues related to the regulation of compounded drugs, taking steps to address concerns that have been raised by pharmacies regarding a 2015 draft. The concerns raised centered on the potential for restrictive distribution policies laid out would impede patient access to compounded drugs for which there is a legitimate medical need. FDA liberalized the provision that was of concern in a way that would allow more compounding pharmacists to distribute compounded drugs. The agency also signaled that in the coming months there would be several more actions in relation to compounding to shore up safety with regard to their development and use and cited as an example the existence of unsanitary conditions in settings were drugs are produced. 

Things to Keep an Eye on This Week

September 12 – Workshop – Regulatory Education for Industry – Complex Generic Drug Development 
September 12 – AdComm – Pharmacy Compounding Advisory Committee  

Regulatory Developments in Pharma/Biotech/Devices

FDA launching new program to review moderate risk devices
FDA launches pilot program to advance innovative clinical trial designs 
Public meeting set by FDA to examine drug shortage causes
Comment period on development of gene therapy products extended

Photo by Joe Leahy on Unsplash

 

 

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