Companies balk at "burdensome" DTC TV pre-review plans
The FDA was granted authority to mandate pre-review of DTC TV under the 2007 FDA Amendments Act. Why is the agency just now asserting that power? It's not in response to any particular ad or series of violative ads, said a spokesperson. Rather, “much research and work went in to the development of the categories of TV ads and the draft guidance,” she said.
“The ads continue to be problematic and governments will always take authority when there's an opportunity to do so,” said former FDA associate chief counsel and Pfizer senior corporate counsel Arnie Friede. “It's a real open question as to whether they will have the resources to implement this in a way that accommodates the needs of industry in the absence of a user-fee program.”
The 2007 law was designed to address funding and staffing through a pharma-funded user fee program specifically for DTC TV advertising, but that program was blocked by an ad-phobic congressional committee baron, Rep. Rose DeLauro (D-CT).
“FDA will allocate the necessary resources to meet the timeframe contained in this section of FDAAA,” said the agency spokesperson. That timeframe is 45 days before an ad is scheduled to air, which is to say 45 days from the time that the agency receives a complete submission. Should agency reviewers blow their own deadlines, as the chronically-understaffed ad review teams are wont to do, the agency's March draft guidance says, essentially, that it's the manufacturer's call as to whether or not to proceed with the ad and that “once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA's comments”—though given the high price of airtime and the need to purchase it well in advance, that option carries a lot of risk should FDA find something objectionable in an ad that's already airing.
That's what's got companies that submitted comments most worried. Sanofi, Boehringer Ingelheim and Shire all argued that the requirement that companies submit a final recorded version of the TV ad was unduly burdensome. The agency has allowed that companies can comply in two steps—first submitting an annotated storyboard and then, closer to the air date, a recorded version. However, as Shire execs said in their comment, this two-step process “would double the time and resource burden on sponsors as well as the agency.”
Boehringer Ingelheim proposed that the agency allow submissions of annotated storyboards in lieu of a recorded ad. “Given the considerable costs of discontinuing a broadcast advertisement deemed misleading by the Agency, it behooves sponsors to submit storyboards submitted for advisory comments that are representative of the final ad and to ensure that the Agency's advisory comments are incorporated into the filmed version,” said the company's comment.
PhRMA supports a voluntary pre-review program but said a mandatory program may violate companies' First Amendment rights.
“A governmental restriction that operates as a ‘prior restraint' on expressive activity is one of the least tolerable infringements on First Amendment rights, and there is a ‘heavy presumption' against its constitutionality,” said the trade group in its comment.
The agency anticipates around 80 submissions of ads for drugs from 30 companies per year, along with a couple for biologics, and estimates that it will take companies around 25 hours to prepare and send the review package and documentation.
The FDA closed its comments docket for the draft guidance on May 14.