FDA and The Scarlet Letter

FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block the development of generic drugs. There is no doubt that the arc of progress favors greater transparency on many levels in many areas. This may or may not be one of them. 

In the media there has been some question as to whether or not this is “shaming”  pharmaceutical companies who have refused samples to those seeking to develop generic competition. It raises some important questions. Just a few, for example, is publication of the names of these companies an effective means of deterring this delay?  Is it needed? And is publication of a one-sided allegation advisable?

Is it effective?  Time will of course tell. But a lot of information gets published on the FDA website that is unpleasant. If a manufacturer does not meet current good manufacturing processes, they are sent a letter from FDA demanding compliance. The letter and the damaging information are there for all to see.  Does that action deter manufacturers to the point that compliance is enhanced?  One could argue it does, but nevertheless, the letters are still issued on a regular basis. And before FDA’s Office of Prescription Drug Promotion dramatically slowed down its enforcement to a trickle, letters were also published on the FDA site that cited regulatory violations for what the agency considered inappropriate promotion. So the idea of publishing violations on the FDA site is not new. Is it a deterrent? FDA’s OPDP seems to have given up. Meanwhile violations of good manufacturing practices still occur. Would there be more if the letters were not published?  We don’t know.

Is it needed?  FDA has cited a number of complaints regarding manufacturers who have not provided samples. But are the letters aimed at many or a few manufacturers? Do they involve many or a few products?  It isn’t entirely clear. That said, FDA has said there are 150 such letters – reportedly impacting about 50 brands. And still last year FDA approved over 1000 generic drugs – a record year. The year before that – at 813 – was a record year as well. So while there may be some bumps in the road with some manufacturers, the numbers indicate a healthy pipeline of generics and 50 is not a very large number in comparison. So it is logical to ask the question, is this a solution in search of a problem?

Is it advisable?  That invites lengthy discourse. Obviously FDA thinks so. But what is being provided is one-sided story. A manufacturer submits one side of the story. FDA publishes it. But is a manufacturer going to be permitted to submit and publish their rationale for delay?  Are there circumstances that might justify a point of view for delay?  Moreover, does this really address the issue of pricing. Yes, the more generics that exist, the more prices come down. But is this addressing the issue of pharmaceutical pricing on a broad scale, or is it a nibble at the issue from the edge?  Generics, after all, come on to the market when a patent has expired. The most expensive drugs that are on the market often, though not always, tend to be those which have been newly approved. This may address a part of the pricing issue, but actually it would appear to be a relatively small part. 

President Trump this week gave a speech this week on pharmaceutical pricing that followed a campaign alleging that industry was “getting away with murder” that was accompanied by a blueprint entitled “Putting Patients First“. But the blueprint – which implies a plan – while many pages was long on ideas and short on action. After the speech, pharma industry stocks shot up. And for those advocates demanding action, the plan was more like Putting Patience First. As a first step out of the starting gate, publication of these letters is a small and incremental effort and yet as the first, it is going to get a lot of attention. But as to the substance, it is painting the pharmaceutical industry with a broad brush stroke when generic approvals have been at record levels and it certainly does not go to the heart of the matter of pricing. 

Photo by Larry Costales on Unsplash

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  1. Pingback: Weekly Roundup 5.18.18 | Eye on FDA

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