Weekly Roundup 11.9.18

So much to talk about, so little time. The election (thankfully) is over. The days are shorter, darker, wetter and altogether more lean. Thanksgiving is but a few short weeks away and Christmas decorations are already sneaking their way into stores and our psyche. There is a rush to finish all that needs to be finished before the end of the year, and perhaps it is no different at FDA where there has really been a good deal of activity over the calendar year, much of which we will visit in some year-end look-backs. In the meantime, here is what happened this week. 

  • FDA and Expanded Access – Expanded access to drugs under clinical study is important on many levels – access for the patient, protecting the integrity of clinical trials, and of course patient safety. In a statement this week, FDA Commissioner Gottlieb announced improvements to the expanded access program that streamline the process even further by requiring less documentation and involving fewer individuals in the approval process. The agency also clarified how adverse events experienced through the expanded access pathway would be considered in the context of the review process for investigational treatments. In addition, changes have been made to improve the usability of the expanded access website, reducing duplication and adding new pages of commonly requested information. The statement also clarified that this program is distinct from the “Right to Try” legislation signed into law earlier this year and that FDA is in the process of considering what steps are needed to implement that legislation. 
  • OTC Asthma Medicine Returns – Commissioner Gottlieb and CDER Director Janet Woodcock issued a joint statement this week about the return to market of a new version of Over-the-Counter Primatene Mist, the only OTC metered-dose inhaler for use in providing temporary relieve to mild, intermittent symptoms of asthma. It is approved only for persons who have been diagnosed with asthma by their healthcare provider. While there was a former version of OTC Primatene Mist, it was removed from the market in 2011 due to the fact that it contained chlorofluorocarbons (CFC) propellants known to be harmful to the earth’s ozone layer. In the wake of the removal, the two said that there were considerations as to whether having an OTC asthma product improved access for patients or actually caused patients to forestall needed treatment. They acknowledged that there is a narrow population of people diagnosed for whom an OTC asthma inhaler would have benefit, but that appropriate use needed to be reinforced. 
  • Deadline Today on FDA Response to Senator Inquiries on Pre-Cert Program – On October 10, 2018, Senators Warren, Murray and Smith sent a letter to Commissioner Gottlieb and to CDRH Director Jeffrey Shuren containing a long-list of inquiries about the nature of the FDA pre-certification program for software being used in medical devices. The letter included nearly two dozen questions on a range of topics including particulars about the legal underpinnings of some of the aspects of the proposed pilot program that FDA is developing to allow specific manufacturers to facilitate the pathway to market for software used in some medical devices. The deadline for FDA’s response was today, November 9. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices/Food

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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

Regulatory Developments in Pharma/Biotech/Devices/Food

 

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

Regulatory Developments in Pharma/Biotech/Devices/Food

 

 

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

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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Posted in FDA Policy, Warning Letters | 2 Comments