Dive Brief:

• The Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) has sent four enforcement letters so far this year, continuing a downward trend that may wind up below the previous record-low of five in 2017.
• Regardless of 2018's final tally, the number of warning letters issued by the agency has steadily declined since a recent peak in 2010 of 51 letters, which is still far off from highs hit in the late 1990s.
• Julie Tibbets, a partner in the technology and life sciences group at the law firm Goodwin, explained the FDA seems more focused on writing guidance than letters, which could lead some marketing and legal teams to adjust their risk tolerance for campaigns going forward.

Dive Insight:

The FDA is "walking very carefully" with OPDP's use of warning letters due to legal concerns, noted Center for Drug Evaluation and Research director Janet Woodcock in a Sept. 21 talk.

"Each one of those cases or letters is a joint effort between the Office of Chief Counsel and OPDP because of the First Amendment implications of all of this," Woodcock said. "We're looking at these things carefully, but we really have to recognize the current jurisprudence."

Woodcock posited the hypothetical that if one company says their acne drug works faster than a competitor, the agency can "let them duke it out."

Tibbets has studied these letters and reasoned the drop-off is also related to the FDA office's focus on drafting guidance documents, taking resources away from finding companies that could be worthy of sending letters to.

"It does seem that their desire to issue more guidance for industry, especially in the last couple years, has really attributed to the downward trend," Tibbets said in an interview with BioPharma Dive.

Out of the four letters for 2018, none were formal warning letters. Additionally, two of the four untitled letters seemed to directly result from FDA personnel attending medical society meetings in 2017, Tibbets noted, calling those meetings "low-hanging fruit" for the FDA to act upon.

That's a substantial drop-off from 2010, when the FDA sent 51 such letters, including 13 formal warning letters.

She said the lack of letters also gives the sense that "they aren't really combing through the materials they receive" in the required Form FDA 2253 submission, which is where pharmaceutical companies submit advertising and promotional labeling to the agency for review.

An FDA spokesperson pushed back on these claims, saying a "risk-based approach" is implemented to use agency resources.

"Therefore, one cannot get a complete picture of the FDA's program area by looking at a snapshot of time for warning letters," the agency spokesperson wrote in an email to BioPharma Dive. "To help increase voluntary compliance, the FDA continues to devote additional resources to its work on guidances and providing advice to companies for draft promotional materials, where appropriate."

However, the steady decline in letters could cause companies to rethink their marketing strategy, and perhaps re-evaluate what they can get away with, the Goodwin lawyer warned.

"I think [there] could be a risk that companies alter their risk appetite in the promotional space and recalibrate based on what would appear [to be] a really rare chance they may be on the receiving end of one of these letters," Tibbets said.

Looking ahead, the burning question for the pharmaceutical marketing industry will be if this downward trend is temporary or permanent.

Tibbets believes it's "hard to predict" when the number of enforcement letters could tick up, but said she does believe an increase will happen.

"I think at some point there is a shift that has to be coming once the agency completes more of its guidance-planned activities," she said. "It's just hard to know when that tipping point is going to be."