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.
Photo by AbsolutVision on Unsplash
