In April, we updated (here) you on the long march to FDA guidance on the promotion of medical products over the Internet and social media. The FDA’s Director of the Office of Prescription Drug Promotion, Thomas W. Abrams, had just given an interview to Pharmalot and said that the FDA had made it a priority to issue such guidance. The Food and Drug Administration Safety and Innovation Act sets July 9, 2014 as the deadline. But it was somewhat worrisome that Director Abrams didn’t call it a deadline. He chose to call it a “timeframe.”
Now, we haven’t formally researched the FDA’s record of success in meeting statutorily-imposed deadlines. But we did Google “FDA misses deadline.” You can do that too. Go ahead, we’ll wait. . . . . . . . . . . . .
. . . . . . . . . Not encouraging, is it?
We’ve also followed a lawsuit filed in California by two public interest groups seeking an order (i) declaring that the FDA violated the Administrative Procedures Act (APA) by not meeting a statutory deadline to issue certain food regulations and (ii) compelling the FDA to do so by a date certain. There, the FDA argued that the question wasn’t whether it failed to meet a Congressional statutory deadline but rather whether it unreasonably delayed. In deciding that, the FDA argued that the court should consider a number of factors, including whether Congress had provided a “timetable.” Timetable? That sounds too much like Director Abrams’s “timeframe.” More reason for worry? Fortunately, the court called a deadline a deadline, not a timeframe. And, since the FDA didn’t meet it, it violated the statute and the APA.
This should give us reason for optimism. But not so fast. While the court determined that it had grounds to use an injunction to impose a deadline, it didn’t. It was swayed, not surprisingly, by the FDA’s argument that an improper deadline could produce insufficiently considered regulations, something that nobody wants. So the court ordered the FDA and plaintiffs to meet and confer and come back on May 20, 2014 with agreed-to deadlines. But they didn’t. They came back looking for more time – until June 10, 2014. And so it continues.
So what is there to learn from this? Well, probably nothing that we didn’t already suspect. There’s a chance that come July 9, 2014 we won’t have the guidance that much of the industry is waiting for. That’s not good news and, if it happens, it will be frustrating. But we’d be remiss not to note that it’s a possibility.
But there’s reason for hope too. The FDA has been considering Internet and social media guidance for a long time. Its initial two-day hearing on it was held in 2009. That has given the FDA an awful lot of time to put together task forces, teams, working groups and whatever else it needs to set about completing the guidance. And two months ago, more than a year in advance of the July 9, 2014 deadline, the FDA publicly announced that it has made issuing such guidance a priority. That’s good too. And, remember, this will be a guidance document not formal regulations like in the food case. We can hope that that also gives the FDA room to finish its work on time. Because, as we’ve seen on Google and in the food case, there’s not much if anything industry can do to force the FDA to meet its deadline. So we’ll just continue to wait and watch — and probably blog on it.