Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any year previously.
COVID certainly made a big impact – a whopping 65 percent of FDA press releases had to do with the subject of the pandemic. In late March FDA began issuing Coronavirus Updates labeled as a “Daily Roundup” except they weren’t actually always a daily release – some days got skipped. In all there were 165 of them. Then in addition, FDA began issuing releases containing updates independently of the daily updates that relayed news of a special development. And then on top of that, sometimes the agency issued a regular press release having to do with a COVID-related matter. In any case, they talked a lot about COVID-19 this year, as one might expect. In all there were 274 releases about COVID.
What were they talking about? There were 104 releases involving approvals (compared to 92 the previous year) – 58 of which were about the approval of drugs; 42 of which involved the approval of devices; 1 gene therapy; 1 involving an animal product and 2 of which were vaccines. Approval announcements includes those related to Emergency Use Authorization (EUA) which is not technically an approval. There were 28 releases announcing an approval related to an EUA, which overwhelmingly involved the approval of one of the many tests authorized by the agency this past year, as well as those involving the use of remdesivir and blood plasma.
Outside of COVID, there were some notable approvals, including the first treatment for peanut allergies in children, the first therapy for children with a rare and disfiguring rare disease, a new therapy for heart failure, the first treatment for Ebola and the first imaging for Tau Pathology in patients being evaluated for Alzheimers.
FDA’s policy for translating press releases into Spanish is mystical. Some releases are translated, some are not. The subject matter sometimes seems to be a guiding factor, but it is really unclear. It is a handy thing, of course, for the nation’s Spanish-language newspapers and for patient organizations making information available. But this year, they only got about 20 percent of the time, 12 percent of the COVID-related releases. The Daily COVID-19 updates were not translated.
One additional note on FDA’s communications this past year. As late as December, FDA continued the ill-advised though infrequent practice of politicizing press releases with the use of the term “Trump Administration” in the headline. While that temptation will necessarily evaporate in a few days time, it speaks to an issue that FDA has before it for 2021 which is specifically to restore any damage to the agency’s credibility from the events of this year. The agency took some pains to demonstrate transparency during the vaccine authorization process – holding an advisory committee meeting on each vaccine and issuing a press release prior and subsequent to the meetings. That is a beginning. During 2021, the agency will have to do more.
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