July 13, 2018 – On the “no news is good news” front, the House Appropriations Committee voted this week on next year’s funding level for the U.S. Department of Health and Human Services (HHS) without taking up an amendment to give HHS and FDA explicit authority to mandate drug list prices in consumer advertising.
“What doesn’t happen in Washington may not make the news, but it is still important,” Coalition for Healthcare Communication Executive Director John Kamp said. In this case, “a bad DTC bill didn’t happen.”
According to Kamp, the Coalition was watching the Appropriations Committee markup very carefully “because we and drug lobbyists, including PhRMA, feared Rep. Rosa DeLauro (D-CT) would offer such an amendment mirroring a similar effort by Sen. Richard Durbin (D-IL) in a recent Senate Appropriations hearing.”
Kamp explained that industry members were concerned about Rep. DeLauro, who last session of Congress offered another amendment that would have delayed consumer advertising for three years after a drug is approved.
DeLauro “posited it as a way to avoid widespread use during those years because of possible side effects that did not show up in clinical trials,” Kamp said. “Interesting idea, but financially devastating for drug sponsors. Not to mention that it would have delayed effective treatment to patients in need. Thankfully, that measure, like yesterday’s, went nowhere.”
However, Kamp noted that Sen. Durbin did succeed to in getting Report language on the DTC price mandate in the Senate Appropriations Bill that could well be part of the final bill. “We’re watching it carefully and will be working with allies to strike it before final passage,” he said.
For background, that Report language assumes that HHS has authority to impose such a mandate and demands a report from HHS within 60 days on several aspects of the issue.
Most importantly, Kamp asserted, industry should know that this Congressional debate, spurred by a similar White House and HHS initiated proposal, “likely will delay action by FDA on a related proposal to simplify the lengthy disclosures in DTC advertising. That, of course, is a very disappointing side effect of this entire controversy.”