Weekly Roundup 1.26.18

The funding kerfuffle came and went. Order was restored to the universe after a brief blip shuttered federal agencies, FDA among them, for a single work day.  It almost seems like a distant memory already, until next time. The weather has returned to its global warming trend with unwintery temperatures. Not only has FDA been open for business, but there is a lot of stuff coming up. Here is a bit of what happened this week that you may wish to know about. 

  • OPDP Issues 5th Letter of the Year – The Office of Prescription Drug Promotion (OPDP) may have surprised many by posting the fifth, and presumably final, letter issued by that office for the year 2017.  An untitled letter, the violation was promotion of an unapproved product and the communications vehicles involved were a website and a brochure. In 2016, OPDP had also issued some letters for unapproved product promotion which up until then, had been a comparatively rare violation. By my count, there have been only 14 letters since 2010 involving this violation (for 15 violations), 4 of which were in 2016. The most recent involved statements made on a website and in a brochure regarding safety and effectiveness of an investigative agent. 
  • FDA/FTC Warn on Unapproved Opioid Cessation Products – A joint set of warnings were issued by FDA and FTC this week to twelve marketers/distributors of products with thereapeutic claims of efficacy in opioid cessation without approval.  The list of claims involved in the product promotion ranged from “Safe and effective natural supplements that work to ease many physical symptoms of opioid withdrawal” to “Break the Painkiller Habit”. In addition, FTC issued a fact sheet with information on accessing the right help for opioid addiction.  Prior to this action, FDA has taken several steps to address various aspects of the opioid epidemic, including approval of new medication-assisted treatments
  • FDA AdComm Burns Modified Risk Tobacco Product – Sorry I couldn’t resist the headline.  The Tobacco Products Scientific Advisory Committee met this week to consider an application DOE  modified risk tobacco product. Three variations of “Heatsticks” – a mechanism that heats but does not burn tobacco, referred to as IQOS- were discussed and first considered were claims that the manufacturer sought for the products. According to published reports (transcript or minutes are not yet available), the claims that were sought stating that the product would reduce the risks of tobacco related disease and that the products presents less risk of harm to the user than traditional tobacco smoking and both were voted down by the committee and ultimately did not recommend approval by FDA. 

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

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Is FDA Running Out of Juice on Social Media?

FDA held a public meeting in April 2009 on the regulation of promotional speech on social media by medical product manufacturers and set the framework for the discussion (and the subsequent regulation) by asking five questions. Ostensibly guidance was to follow in short order, but in fact, many years passed before FDA issued guidance documents that only partially addressed the questions raised in that framework. The most comprehensive of these guidance documents were about correcting misinformation by third parties on the Internet and operating in platforms where there is character space limitation. Left unanswered were many questions such as issues related to adverse event reporting, among others. 

The sluggishness of the agency is in many ways understandable.  Digital media is fast evolving. Platforms develop rapidly and raise many new questions. Platforms also come and go. On the other hand, FDA’s process moves slowly and keeping up is difficult. Many times on this blog have I opined that moving from a system that is reliant on guidance development to something that operated more quickly, such as advisory committee on communications, might help speed things along. 

But while digital health is exploding on many fronts and healthcare information abounds via social media, rather than speed up, it would seem in many ways that FDA is still focused on traditional communications vehicles when it comes to regulation from the Office of Prescription Drug Promotion (OPDP), per recent indicators.

First, the publication of the 2018 Guidance Agenda from the Center for Drug Evaluation and Research (CDER) has been posted to the CDER website and under the category of Advertising, there are only plans for two guidance documents, neither having to do with digital or social media (though presumably could include them as elements). 

FDA is an evidence-based agency, both in terms of the products it reviews for approval as well as in the way it regulates. That brings us to the second indicator – the Office of Prescription Drug research agenda. There are currently listed 13 “Research in Progress” efforts going on. A number of them are focused on DTC advertising and two specifically are on television advertisements. Some are focused on Print ads and others are non-specific to print or broadcast. But there is only one that is involving digital/social – a project focused on character space limitation. Nothing on adverse events – nothing on optimizing a website for mobile. 

A relatively recent research project undertaken and published by the agency looked at how DTC advertising in the form on landing pages for promotional websites treated drug benefits and risks when optimized for mobile and concluded that there were inconsistent approaches. The outcome is hardly surprising since FDA has provided no insight into its thinking on optimization for mobile or parameters for designing a landing page for an approved drug for mobile. FDA’s evidence based approach means that actual practice runs far ahead of critical FDA thinking, just as it did in 2009 when OPDP issued a slew of letters regarding banner ads to 14 companies for incorporating risk by link. 

Comparing FDA’s pace in evolving the agency’s regulatory thinking regarding social and digital with the actual developments in these platforms shows a vast gap. Yet the uses and reliance on social media continues to go up. Unfortunately, judging from what is visible with FDA’s plans as made public through future guidance development or research in process indicates that this gap will be narrowing any time soon. 

For an overview of milestones related to FDA and social media, check out the tab on the Eye on FDA blog

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What They Said – FDA Press Releases 2017

Keeping our eye on FDA press releases as one measure of the way FDA talks to us is a regular feature here on Eye on FDA and there is no better time to look back than when we begin a new year, particularly as we do so with a new FDA Commissioner.

Overall, FDA has been pretty consistent over the years in the way that the agency communicates. When looking at 2017, however, there are some notable differences. 

On the consistency side, with the exception of last year, FDA has issued about the same number of press releases from year to year. In 2017, there were 164 releases, which is on par with 2015, 2014 and 2013. Last year, the number was only 122, however, so we are back on track when it comes to volume.

When it comes to the way FDA is communicating, there are big differences in 2017. As noted in a posting in late November – A Manner of Speaking – Commissioner Scott Gottlieb has made liberal use in conveying information via the issuance of “Commissioner Statements”. In fact, in 2016, there was just a single such statement issued by then FDA Commissioner Robert Califf. In 2017 there were 36, one of which was by Dr. Califf and the balance by Dr. Gottlieb.  As mentioned in the prior posting on the matter, it is a way for Dr. Gottlieb to mark progress on a number of fronts and signal for the attention of key stakeholders. It is also a means for putting his personal stamp or brand on what is happening at FDA.

One of the things that accounts for the substantial increase in releases in 2017 over the previous year was the increase in the number of approval announcements. In 2017, there were 77 approval-related announcements of either a new drug, device, biosimilar or other medical product compared to just 59 the year before. 

The increase in General Announcements for this year – a category that is a catch-all for grant awards, program launches, study outcomes and the like – is due in large part to the fact that Commissioner Statements are usually included in this category unless making an announcement specific to one of the other categories. 

Finally, the approvals profile for each year varied considerably with 49 of the 2017 announcements involving the approval of a drug, expansion of a drug label or approval of a biosimilar, compared to 32 such announcements in 2016. For devices there were 25 approval announcements this past year compared to 26 the year before. But the big standout in 2017 was the approval of the first 3 gene therapies. 

Overall, with the exception of last year, the volume has remained fairly consistent, but this year certainly saw some changes in both substance and style.

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Weekly Roundup 1.19.18

As noted below, next week the Senate HELP Committee will hold Part 2 of a hearing series on public health threats in the 21st Century. Ironically this comes at the same time we are facing a series of deadlines to keep the government funded and open when in fact, a threat to public health is manifest in a government shutdown. One wonders if they will include the inability of Congress to function as a 21st Century threat in their deliberations. 

But closer to our world, it was a busy week at FDA and in healthcare overall. FDA issued five press statements in a single day this week – one of which was regarding a new pilot program in transparency discussed in a posting on Wednesday. In addition, here is a bit of it that I’d like to bring to your attention. 

  • Shutdown Impact – What Does it Mean? – As of this writing there is a diminishing pathway for an agreement that will keep the government open. The impact of failure on FDA is  bit murky. For those with long memories, the last time this happened it occurred for an extended period of time and FDA had to furlough a large portion of the workforce. What does that mean for those with business before the agency?  The last time, there was an effort to continue with user fee funded activities. If that holds true, it may not affect PDUFA date announcements (I count at least 15 PDUFA dates upcoming between now and the end of February). For public meetings scheduled during a time of shutdown, they may have to be a delay. Last time inspections were said to have stopped and it is probably safe to say that the Office of Prescription Drug Promotion will unlikely issue any letters. For media announcements,  it is also my recollection that there was a brave soul who stuck it out in the FDA media office. I
  • Administration Announces New Division on Religious/Moral Protection – Health and Human Services announced the opening of a new division within the HHS Office for Civil Rights (OCR) to support the positions of those who have “rights of conscience and religious freedom” the purpose of which is to enforce federal laws protecting those rights. In the release about the new division, the head of OCR stated that “too long, governments big and small have treated conscience claims with hostility instead of protection, but change is coming and it begins here and now.” The rationale for the action rests in part, the release said, on not having people being “forced to choose between helping sick people and living by one’s deepest moral or religious convictions…” There was no mention on ensuring access for the sick to unbiased care. 
  • FDA and Department of Defense Launch Program for Expediting Approvals for Military – In 2017, concerns on the part of some that FDA moved too slowly in approving new medical products used in combat care resulted in the possibility of approval authority for emergency use of unapproved products to the Department of Defense (DoD). Some media reported that Commissioner Scott Gottlieb had urged for the authority to remain with FDA and suggested an alternative means of expediting access to such products for military use. This week FDA announced a joint program that would do just that. The program is described as one whereby DoD would request FDA to expedite development of reviews of products for American military use and that FDA would then treat such products in a manner similar to what is available under the existing breakthrough designation that FDA now provides for drug manufacturers, meaning the medical product under consideration will receive involvement of top senior managers, intensive guidance and all features of Fast Track designation.

Upcoming Events to Keep an Eye on This Next Week

Regulatory Developments in Pharma/Biotech/Devices

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Taking a Peek at Transparency – An FDA Pilot Program

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S. 

Specifically, FDA is introducing a pilot program that will publish “clinical study reports” – reports prepared by drug sponsors that provide “bottom line information” on both the methods and results of clinical trials. The announcement acknowledges that while currently summaries written by FDA’s medical reviewers are released by FDA when a drug is approved, the format might challenge stakeholders who are looking for information. 

The pilot program, to begin this month, will involve the posting of portions of clinical trail summaries from the pivotal trials that were submitted by FDA from drug sponsors and will involve the summaries of 9 companies who volunteer the use of their new drug applications and that participation will include a range of therapeutic categories. 

One thing not mentioned in the announcement was the issue of complete response letters (CRLs).  For a long time now, many stakeholders have advocated that CRLs, now considered proprietary, be made public in the interests of greater transparency.

Other questions with respect to the program that were not addressed in the announcement were its anticipated length – how long the program will take to have 9 volunteers, and any outline as to how the success of the program will be evaluated and what steps, if successful, will be taken to make the program permanent.  Finally, if made permanent, would participation continue to be on a volunteer basis?

For many stakeholders, as seen in some of the response on Twitter, this initiative is not going far enough and there are critics who feel it needs to be a broader effort, especially with respect to the CRL issue. One thing, however, that is clear (pun intended) when it comes to transparency is that when you open the door a little, it is pretty hard to close it again. With the advent of the pilot program, it would seem difficult for FDA to go back unless the evaluation of this pilot is absolutely dismal. The arc of progress is with greater transparency. 

If interested, there was also a panel discussion held yesterday morning by the Johns Hopkins Bloomberg School of Public Health – A Forum on Transparency at the U.S. FDA that included two panels and a keynote from Commissioner Gottlieb. 

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Posted in Clinical Trials, FDA Policy | 2 Comments