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 It is the aim that a proposed rule and a draft guidance will provide two means of impacting the price of medicines through different avenues of importation.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.