The FDA gets its marching orders

FDA nerds, rejoice! On Monday, congressional appropriators released their report language for the 2020 FDA funding bill. For the uninitiated, this is where appropriators get to not-so-subtly demand what the FDA works on next year, and also what it wants the FDA to stop doing. As is often the case, the report is long, and covers a hodgepodge of oddball issues like the weight of canned tuna, early retirement for chimps, and even pentobarbital in dog food. (Do I have your attention now?)

Here’s three not-so-oddball issues that caught my eye:

1. Congress is backing stronger regulation of cosmetics and dietary supplements, and they’re willing to put up the money to support those efforts. (Or at least, they’re willing to put it into the report.) The committee has promised an additional $3 million for the FDA’s dietary supplement office and $4 million for its effort to begin actually regulating cosmetics. More funding may be coming, too, at least in the cosmetic space — appropriators are requesting a briefing on “the staffing and budget resources it would need to improve its oversight of cosmetics, including whether the agency believes user fees would help to improve such oversight.” (A friendly reminder that Congress would still have to pass these funding bills for the FDA to get these funds.)

2. Appropriators seem to be softening on the FDA’s regulation of compounding. In the past, appropriators have made no bones about their gripes with the FDA’s approach toward compounding, but the tenor doesn’t seem so tense this time around. Though they’re still requesting a briefing with the FDA on the hot-button issue of “office use compounding,” appropriators also seem to be realizing that the agency isn’t going to altogether switch up their approach. For example, they applauded the FDA’s new draft agreement with states over compounding regulation, even though groups like the International Academy of Compounding Pharmacists are still pushing for sweeping changes to the agreement.

3. Appropriators are leaning on the FDA about as hard as they can to get something done on CBD. The committee writes that it expects the FDA to find a way to allow CBD supplements, while also making sure there’s a reason for drug makers to put CBD drugs through the FDA approval process. If you’re thinking, "Well, how hard could that be?" then you clearly weren’t in the room Friday when the FDA heard from more than 100 speakers, all of whom had their own ideas on how to regulate CBD. The co-director of the FDA’s CBD working group, Dr. Amy Abernethy, summed it up well. She said on Twitter that she “Appreciate[s] a speaker’s observation: 'You guys have a tough job. Good luck with that.'" She added: “Indeed.”

(Want to know more about CBD? May I suggest my dispatch from Friday’s meeting, my deep dive on the regulatory issues around CBD, or my interview with recent commissioner Scott Gottlieb?) Stay tuned for more — we aren’t done yet!