What marketers need to know about tax reform, off-label promotion, pricing



To sum up the Coalition for Healthcare Communication's annual Rising Leaders Conference in Washington in one word, it would be uncertainty.

The uncertain future of health insurance coverage, how the Senate will revise the ACA-replacement bill, and the lack of public palatability for the current drug-pricing system, there is no shortage of potential changes on the horizon for drugmakers and their marketing partners.

See also: Califf calls for marketers to develop off-label 'code of ethics'

But, to hear Tuesday's speakers tell it, that uncertainty breeds opportunity. Here are some thoughts, excerpts, and prognostications on the future of healthcare communications.

When it comes to tax reform, everything is on the table.

Part two of President Trump's legislative agenda, to reform the country's tax code, will once again raise the possibility of killing the advertising tax deduction, said Dick O'Brien, EVP of government relations for the 4A's. “It's the biggest fight we have this year,” he said. “Grassroots meetings are going on right now to key congressmen and senators.” He estimates that the impact of losing the ad-tax deduction could cost the industry $169 billion in business over a 10-year period.

Don't expect FDA guidance on off-label promotion to patients anytime soon.

The regulator's policy development for off-label promotion “seems to be focused on payers and professional audiences, [there's] no move to go into the consumer area and liberalize those rules,” said Wayne Pines, a former FDA associate commissioner of public affairs and now a consultant at APCO Worldwide. “As far as I know, there are no guidances that are being drafted that deal with a difference in existing FDA policy with regard to consumers. I could be wrong, but I don't see it happening in the consumer area. It doesn't seem to be high on anybody's list to try and change that regulatory framework.”

Don't expect substantive action on prescription drug prices.

“I don't have high hopes for the hearing,” Sen. Chris Murphy (D-CT) said about a planned but unscheduled hearing on drug prices held by Sen. Lamar Alexander (R-TN). “In part because it seems pretty clear the Senate Republicans will be obsessed with repeal of the ACA, leaving no space to have a concurrent conversation. I worry that this is a hearing to mollify his caucus and a larger group of Democrats.” Alexander, chairman of the Senate Health, Education, Labor and Pensions Committee, said earlier this month he would schedule a hearing to discuss the issue following a request from Sens. Bill Cassidy (R-LA) and Al Franken (D-MN).

Payers are not immune to the drug-pricing debate.

“At some point, someone is going to take a good look at PBMs,” said Mit Spears, attorney, and former EVP and general counsel for drug industry lobbying group PhRMA. “Many rebates don't find their way back to the consumers,” and if that continues, it's going to start looking like a kickback,” he added. Sen. Murphy, too, noted during a separate talk, that “I would hope PBMs would be a part of the [drug-pricing] conversation.”

A call for healthcare marketers to develop an off-label code of ethics may have tipped the Coalition's hand on its future goals.

“We're redefining our mission,” said Sharon Callahan, CEO of TBWA\WorldHealth and chair of the Coalition for Healthcare Communications' executive committee, about its plan to develop a code of ethics for off-label communications. “Our next step is to develop guidelines for industry so each agency doesn't have to do it alone,” she said. “We represent all the major holding companies as well as many of the top independents, if we can agree to that, it will elevate what we do.” Karsten Risch, EVP, chief medical officer, of Havas Health & You, added, “Right now without a code of ethics or guidelines, there is no clear way to say: ‘This is how you communicate'" outside of a drug's label.