Congress eyes restrictions on DTC, med edThe new Democratic Congress is living up to expectations with plenty of bicameral pharma-bashing rhetoric, but has so far failed to implement price controls and ban DTC advertising. That doesn't mean the industry should get comfy just yet.
Of particular concern is a bill co-authored by Senate Health, Environment, Labor and Pension committee chair Sen. Ted Kennedy (D-MA) and ranking member Sen. Mike Enzi (R-WY). Among a raft of measures meant to improve monitoring of drug safety, the bill would impose a two-year moratorium on DTC TV ads for new drugs, mandate FDA pre-approval of all ads and authorize FDA to require certain language be used. At best, that means hours of senatorial bloviating on the evils of drug ads.
“It's going to be bandied about, and the fact that there's something in the bill [regarding DTC] means there's going to be some kind of action,” says John Kamp, executive director of the Coalition for Healthcare Communications.
Adonis Hoffman, SVP and counsel at the American Association of Advertising Agencies, called it “a formidable bill,” noting that last year's version made it out of committee, despite GOP control. “On principal, we have to be very concerned about any kind of statutory requirement that compels a certain kind of speech, aside from communicating risk information,” he said.
An alternative measure, sponsored by Sens. Christopher Dodd (D-CT) and Chuck Grassley (R-IA), offers a more collaborative approach to ad reviews. But Kennedy and Enzi, at the helm of the HELP committee, have the bigger podium.
Such a measure would clearly run into a strong First Amendment court challenge. “We're on pretty safe constitutional ground with respect to our ability to communicate,” said PhRMA's Ken Johnson.
But courts can be unpredictable, and the White House has not indicated a stance on DTC ads—as it has legislation that would mandate direct negotiation between HHS and drug companies on drug prices for Medicare, which elicited the promise of a veto. That bill, The Medicare Prescription Drug Price Negotiation Act, sponsored by Energy and Commerce committee chair John Dingell (D-MI) and passed as part of the Democrats' “First 100 Hours,” package sailed through the House 255-170, with 24 Republican “Ayes” and no Democratic defections. A narrower Senate version, sponsored by Sen. Ron Wyden (D-OR) and Sen. Olympia Snowe (R-ME), faces iffy prospects, as Grassley has promised to block such a bill.
This hardly qualifies Grassley as a friend of the industry. It was, after all, he and his colleague Max Baucus (D-MT) who fired off a letter in December demanding answers from the ACCME on pharma influence over CME content. It remains to be seen whether the duo will accept ACCME's answer or continue probing.
But don't get too stressed out just yet because all this may just be the entrée course for the PDUFA reauthorization logjam to come later this year.