While we recover from the shock of President Donald Trump’s move into the White House, it’s important that we as an industry take a hard look at his campaign promise to “reform the FDA.” It’s hard to be against the concept of reform, but Trump is better known for epithets than policy details. Without those details, it’s good to keep in mind the old saying, “Be careful what you wish for.”
For perspective, let’s look at two data points: drug approvals and marketing enforcement letters.
Prevision Policy senior editor Mike McCaughan addressed drug approvals at the recent Coalition for Healthcare Communication annual policy briefing in Washington, DC, saying the “FDA’s drug approval program is now running at peak efficiency and effectiveness.” Pointing to the five-year high of about 40 approvals in recent years, he continued, “When you’re at the peak, gravity is not your friend.”
Trump reforms or not, those numbers are likely to drop in 2017, as they did in 2016. The FDA approved 22 new drugs in 2016, far below the 45 approvals from 2015. Moreover, the numbers for 2017 are almost certain to be down even more, if for no other reason than the number of pending applications is less than half of previous years. But it is worth noting the approval process at the FDA simply is not broken.
Meanwhile, the number of marketing enforcement letters is at historic lows, dipping from more than 100 in the late 1990s to only 11 in 2016. Low numbers here are good, suggesting high industry compliance and good industry-regulator communications and cooperation.
Given those data points, what’s left to reform? Given some of the extreme ideas we’ve heard so far from the Trump camp, such as enabling approvals on safety alone, we need to be careful of reform efforts.
Sure, we can all quibble about certain aspects of the FDA approval process and the regulator’s enforcement policies, but abrupt, poorly vetted changes would bring uncertainty and risk.
John Kamp is the executive director at the Coalition for Healthcare Communication.