An Overview of FDA OPDP Enforcement for 2019

It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between the time a letter is sent and the time it is posted to the web site, but let’s hope the Office of Prescription Drug Promotion (OPDP) did not send one out as a holiday greeting.

Comparing this year to other recent years, the enforcement actions taken by OPDP was not as sluggish as it has been, but neither was it robust. Long gone are the kinds of years where the agency would issue well over 100 enforcement letters for each and every violation that appeared. Instead now, the agency appears to have areas of concentration where enforcement is focused.

During 2019, as of this writing FDA issued a total of 10 enforcement letters, addressing communications carried in 11 different communications vehicles. While interesting warning letters went out from FDA outside of OPDP – for products containing CBD, for example, our focus is solely on promotional communications. Here are the highlights from this year:

  • Communications Vehicles – Violations were just about evenly divided between digital communications vehicles and traditional ones. On the digital side, there were 5 violations – the most frequent communications cited involved statements made on a website (4), and one letter sent regarding an email. On the traditional side of communications, there were a total of 6 – almost all DTC videos (4)- one of a DTC video involving a patient testimonial – one of the riskiest areas in promotional communications to my thinking. (I categorize DTC video in the traditional category rather than digital). On the traditional side there was also a banner ad and a print DTC ad involved in enforcement.
  • Treatment Area – No single treatment area dominated enforcement. In the broad category of CNS-related treatments, there were two violations, two in oncology, two in erectile dysfunction. In short, there was nothing to indicate that the agency is focused on a treatment area with enforcement.
  • Companies – Small companies watch out. The trend continues for OPDP to aim its enforcement mostly at companies that are generally not considered household names in the industry. This year was almost no different with the notable exception of the inclusion of Alkermes (more on that below). It is unclear whether large established companies have gotten highly adept over the years at scrubbing their communications to the point that they are more compliant with regulations or if FDA is finding that smaller companies provide good examples of violations the agency is concerned about.
  • Warning versus Untitled Breakdown – Untitled Letters – also referred to as Notice of Violation (NOV) letters are considered the less serious of the two categories of regulatory action letters sent by OPDP, while Warning Letters are reserved for those violations FDA regards as more serious. This year, three out of the ten letters issued were Warning Letters. That is on par with a look at the cumulative rate over the years – in my database going back to 2004 that profiles over 330 letters from OPDP, about one in three letters are Warning Letters. So the proportion did not change this year. So even though FDA seems to be reserving its regulatory actions for violations it deems most noteworthy, that does not appear to alter the traditional approach to Warning Letters.
  • Violations and Focus – There were 21 violations cited in the 10 letters issued this year. As per usual, by far and away, the most common violation cited by FDA is one that you would think might be the easiest area for compliance – the inclusion of risk information. This involved nine violations – nearly every letter issued by the agency this year. The other violations were for making a superiority claim (3), unsubstantiated claim (3), unapproved use (1) and promotion of an unapproved drug (2). That last one is noteworthy. While promotion of an unapproved drug was numerically low, it is proportionally high. Historically promotion of an unapproved drug has been an rather uncommon violation, having occurred only 19 times by my count since 2004, but 14 of them have been since 2012 and 11 since 2015, indicating it is a high area of interest for the agency in recent years. So the bottom line – there are two things to watch for in communications – risk information and pre-approval communications – particularly if you are a small-ish company.

Finally, one thing that occurred this year that was highly unusual with respect to enforcement concerning the final letter of the year issued by OPDP on December 2. FDA accompanied the posting of the letter – a Warning Letter – to the website with the issuance of a press release about the letter. That is highly unusual and in fact, I do not recall an instance where the agency brought so much attention to an enforcement action since April 2009 when OPDP (then called DDMAC) issued its misguided set of 14 letters impacting 45 brands. It does no good to second-guess reasoning, but it bears noting that his particular letter involved a drug utilized in an area where all stakeholders, including FDA, have been under scrutiny – opioids. The communications about the medication was lacking important risk information, FDA found. While risk information is obviously an important area of focus in enforcement, it is perhaps even more so for those manufacturers who are operating in the area of pain relief.

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The Growing Profile and Influence of ICER

The year began with a prediction from Senator Mitt Romney to pharmaceutical executives that “change is coming”. There have been high profile hearings on the topic in the Congress and legislation that moved in both the Senate and the House of Representatives. There have been initiatives by the Administration in the wake of a blueprint issued but which has mostly gone nowhere. And the FDA has generated record numbers of approvals in generic drugs and issued policy documents to address two means of importation from other countries. All in all, there has been more talk than action.

But what of the talk? What did the conversation reflect from the past year?

Perhaps one of the most striking answers to that question is related to the emergence of the Institute of Clinical and Economic Review – ICER – from perhaps what could be described as the background of the issue of pharmaceutical pricing to the forefront. A non-profit that has been around since 2006 with a goal of providing a model framework for evaluating medicines for their value versus their cost, ICER has been steadily growing its presence in the media around the issue for a while. But this year in particular, the organization is not only being mentioned more in media coverage on the topic of pharmaceutical pricing, it is having an impact in actual costs and in coverage decisions. In short, ICER had not only a quantitative expansion of presence, but a qualitative impact as well.

This did not happen by chance. Part of the reason for the increasing profile of ICER in the media is of course that pharmaceutical pricing was a premium topic last year. But it is more than that. ICER issues a press release at every juncture of its milestone-ridden process and sends out a weekly report that summarizes its activity as well as overviews media mentions for the organization. In short, the organization has carefully cultivated its media profile.

ICER has seen steady growth in its media profile, but 2019 was a marked increase in mentions in major publications

In a white paper published this week, my colleague Adam Silverstein and I examined the public discourse respecting pharmaceutical pricing in 2019. We look at media coverage of the issue – both the drivers of coverage and the stakeholders involved, in particular the ascent of ICER. You can download the paper here.

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What They Said – A Look at Press Releases Issued by FDA in 2019

In 2019 FDA Continued A More Robust Pace of Engaging Media

It is time to look at the forest rather than the trees. It has been a regular custom to occasionally look back and see what FDA has been saying, and how frequently the agency has been saying it and what the focus has been. During the entire year, we look at individual press releases, but let’s look at the entire body of communications. What is the same, and what has changed?

Naturally we start with a look at the total volume. This year FDA issued 272 press releases, down just a bit from the previous year of 289, but well ahead of the yearly output prior to that. It bears noting that 2019 began in the midst of the longest government shutdown due to an impasse on federal appropriations and which lasted until January 25.

Given that the volume has remained about the same this year over last, what about the subject matter? What did FDA talk about this year and were there any changes compared to years gone by?

  • Alerts – There were 13 press releases regarding alerts to consumers/patients issued this year, compared to 12 the previous year. This year there were fewer for drugs (4) and more for devices (8).
  • Approvals – Despite the fact that there were fewer new molecular entities approved during 2019 than in 2018, there were more press releases about approvals this year (92) over last (74). This year there were 64 press releases about drug approvals, 25 about devices and 2 in tobacco and 1 in gene therapy. Last year there were 47 drug approvals announced and 27 in the device category.
  • Legal Actions – This category includes issuing warning letters, seizures, and consent decrees and announcements were on par with last year – 36 in 2019 compared to 34 in 2018. However, the focus was different. This year there were more announcements regarding drug products over last year (17 in 2019, 8 in 2018) and less involving food (only 1 this year compared to 5 last year). There were also more involving devices this year compared to last (5 in 2019, only 1 in 2018).
  • Recalls – Were about the same – 3 this year compared to 4 last.
  • Rules and Guidance – There was an uptick in announcements of rules or guidance documents from 6 last year to 10 this year.

Commissioner Statements. All of the above categories are impacted to a degree by the presence of Commissioner Statements issued by FDA. Communications output from FDA changed dramatically once Commissioner Scott Gottlieb was at the helm of the agency when the number of annual press releases in 2018 increased a whopping 74 percent over the previous year and more than doubling the rate of 2016. This was largely due to the advent of statements issued from the Commissioner’s office. In 2018, there was an aggressive communications effort mounted from the Office of the Commissioner which began issuing statements from that office in the form of press releases. These offered a platform for the Commissioner to present a more personal point of view directly to stakeholders. Just prior to his departure, and since then, those types of statements continue to come out from the agency, but come from the heads of various divisions. Think of them like a tweet, but without character limits. Many of these showcased announcements of new rules, guidances and policy, while some were there to present a point of view about the agency’s plans or progress in a specific area of concern. The subject matter of these releases would not be captured in the numbers above. In particular, these communications devices are used to explain in greater detail or to spotlight a new guidance or rule that is going into effect.

What we do see about Commissioner Statements is the biggest difference between last year and this is the volume. While Dr. Gottlieb was still Commissioner in 2018, FDA issued 126 Statements from the Commissioner – a number that dropped to 89 for this year, many of which were statements not from the Office of the Commissioner, but from individual division heads within FDA. This is likely the biggest change of all in FDA’s communications as perceived through the issuance of press releases.

Spanish or No? FDA issues some press releases in both English and Spanish. It is not entirely clear, at least to this observer, when that happens and when it doesn’t. It has been difficult to discern a pattern, but last year there were 39 releases in Spanish as well as English, or 13 percent, which compares 32 releases this year which is about 11 percent.

FDA in Brief. One other thing of note. In 2017 FDA began issuing notices called “FDA in Brief” which are mini-missives to announce recent agency activities, but not up to a press release. One would think media and FDA beat reporters likely follow these. It is a mechanism FDA is using with greater frequency. In 2017, there were about 7 issued each month; in 2018 it went up to an average of 8 issued each month and in 2019 it was an average of 9.5.

The output from FDA in 2020 will be determined by the presence of a new commissioner, the lack of a government shutdown, and perhaps by the election cycle. We’ll keep an eye out.

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2020 Vision – Notable FDA Actions During 2019

Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward.

FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a very subjective experience. Even limiting the subject matter to those actions which affect medicine, as opposed to food, devices and cosmetics, there is still a very wide bandwidth of activity and impact. And everyone gets to have their point of view. Having been involved in writing this blog since 2006, here is mine. Some of these noted items are things FDA has done – great milestones and achievements – some involve things the agency has not done – and others may involve situations that are evolving around the agency.

  • Fewer NMEs, But Interesting Approvals – At 48, there were fewer New Molecular Entities (NME’s) approved in 2019 than in the previous year when there were a whopping 59, but it was still more than in 2017, 2016 and 2015, thanks to a spate of approvals in December. That said, there were a number of interesting developments within the greater span of approvals, including some NMEs. These included the approval of two new treatments for Sickle Cell Disease, the approval of the first Gene Therapy (and incidentally the most expensive drug to be on the market); the approval of the third cancer treatment based on the presence of a genetic characteristic rather than tumor type; the approval of two new anti-depressants in a category that has long been without advance; and in vaccines, the approval of the first preventive for dengue as well as one for Ebola and the first test to detect Zika virus antibodies.
  • Three Commissioners in One Year – FDA started the year with Dr. Scott Gottlieb at the helm who surprised everyone with a departure in the Spring. In turn, he was replaced by the solid choice of Dr. Ned Sharpless who worked as Acting Commissioner for most of the year. Another surprise, despite the support of many past FDA commissioners, Dr. Sharpless was not appointed FDA Commissioner. Rather Dr. Stephen Hahn was sworn in as the 24th Commissioner of FDA. How the advent of a new commissioner will impact policy is anyone’s guess. During the confirmation process there was some question as to the commitment he has on the FDA’s efforts vis a vis the vaping industry, but as we learned during the Gottlieb confirmation process, concerns raised before don’t always materialize as deficits after confirmation. Even with the advent of a new commissioner, expect the media shadow of Dr. Gottlieb to extend to future FDA activities and policy announcements.
  • FDA Moves on Importation – Apart from generics, this is the other area where the agency can contribute to the effort to bring down the price of prescription drugs. It was an historic first in many respects – the first time the agency facilitated the pathway for the importation of drugs by issuing a draft guidance document and a rule. The former sets up a regulatory pathway for states and other entities to import drugs from Canada and the latter devises a means by which manufacturers can import drugs from outside the U.S. in order to lower the price in the U.S. though it remains a mystery as to why any manufacturer would likely do such a thing. The other historic thing about the announcement from FDA was that it was the second time the agency politicized the policy announcement by linking it to the Administration – the first being in September. For thoughts on that see the previous posting.
  • CBD Enforcement – CBD is everywhere. Everywhere geographically, everywhere in the span of products – teas, salves, dummies, hand cream, vape pens – you name it, CBD is likely there leading many stakeholders to label it the “Wild West” to signify that it is without oversight. In the wake of the Farm Bill which made legal the growth of hemp, FDA issued a press release in an attempt to preserve the agency’s regulatory authority over its use as an ingredient in supplements, drugs or food. That was despite the fact that the market was already running amok with products containing CBD. After his departure from FDA, Dr. Gottlieb penned an op-ed in The Washington Post outlining what FDA needed to do as the use of CBD was “getting out of hand.” During the course of the year, FDA issued a spate of warning letters to multiple manufacturers of a range of products including food producers warning them against the use of CBD. For an overview of FDA activity on this front, see “CBD and FDA – Where Are We?” Since that posting, FDA has issued additional letters. Can FDA send enough such letters to actually chill the CBD-related product market? Certainly the agency is under a measure of scrutiny given the opioid and vaping epidemics that are also high profile.
  • Record Number of Generic Approvals – The agency approved a record number of new generic drugs – one of the few contributions that FDA can make to impact the price of pharmaceuticals. The agency approved 1171 new drugs during the fiscal year. This follows on the heels of two notable years of approvals in 2017 and 2018 Notable announcements included the approval of a generic version of Advair Diskus, valsartan, naloxone nasal spray to treat opioid overdose, Gilenya – an oral treatment for multiple sclerosis, and the approval of a generic Eliquis in the atrial fibrillation treatment space. In addition, FDA issued multiple press releases during the course of the year providing updates on its progress to enhance the approval of generic drugs. With the backlog clearing out, it will remain to be seen if the pace continues in the new year.

And for 2020? Look for a likely uptick in attention to gene therapies as experience with those approved becomes more apparent and those in the pipeline get closer to the market. Watch what happens on the e-cigarette front given the concerns on the topic raised at the time of the new commissioner’s confirmation and monitor how FDA responds to the most recent criticisms of how the agency has handled the opioid epidemic. Probably best not to look for any further guidance on social media and communications by pharma as most of the research directed by OPDP is looking to traditional communications vehicles. As patients and the public have moved into social and digital for media consumption, OPDP remains with its head stuck in the sands of broadcast DTC.

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Remaining Aloof from Politics

Yesterday FDA issued a press release regarding the much-anticipated actions related to the importation of prescription drugs. It is the aim that a proposed rule and a draft guidance will provide two means of impacting the price of medicines through different avenues of importation. The outcome is not certain and there is a long process ahead in relation to achieving any progress through these means. In other words, the pudding which will be the proof is far from being served up and there is plenty to discuss related to the merits and eventual impact of these actions, whatever headlines may say.

That said, the unusual thing about the agency’s press release was the headline – “Trump Administration takes historic steps to lower U.S. prescription drug prices” – noteworthy on a few counts, but mostly so because it mentions the name of the administration.

I went to my database of FDA press releases and did a search on the names of past presidents. Not one came up. This would appear to the be first time that the agency has issued a press release in this manner. If so, it is an unfortunate precedent.

Is there any real harm? Not in an earth shattering way. But in a highly polarized political environment such as we are in (yesterday there was a vote of impeachment), for a federal agency to engage in any communication that appears to be politically motivated may impact perceptions of impartiality. There are some agencies where there might be particular need to stay away from any political scent in its communications. FDA is one of them.

Several years ago when Plan B was applying for over-the-counter status, the stakes were highly political. Conservatives generally opposed the application while progressives generally lauded it. As the regulatory agency in charge, FDA had to ensure that any decision it was making was not based on politics but on data and science. That is one of the gold standards that must be maintained and preserved to reinforce public confidence in the actions that they agency takes.

It is not the rule, but the exception for there to be political aspects of a regulatory deliberation by FDA either related to an approval or a policy. But it does happen from time to time. For that reason, the agency should strive at all times to maintain the appearance of being separated from the fray and potential bias that can be associated with being political. For that reason if no other, the press release issued by FDA was a mistake – one the agency should take pains not to repeat.

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