What Message is GSK Sending the FDA With Its Appointment of Daniel Troy as General Counsel?

Could it be, “GSK to DDMAC: Drop Dead?” Possibly.

As outlined on Pharmalot (here and here) and by John Mack (here and here), Troy is hostile to the idea that drug advertising should be heavily regulated. In fact, Troy joined the conservative legal think tank Washington Legal Foundation in June 2005, right before WLF launched its “DDMAC Watch” campaign. (DDMAC stands for Division of Drug Marketing, Advertising & Communications.)

The campaign essentially challenges every warning letter that the FDA sends out. (FDA warning letters ask drug companies to change or halt advertising which the FDA believes is misleading.) The position of the WLF is that FDA has extremely limited authority to control drug advertising, which should be First Amendment protected speech.

Further, WLF believes that the current regs banning off-label promotion should also be thrown out, to allow drug companies to distribute scientific literature for unapproved uses. The FDA is currently reviewing that regulation.

The WLF, for whom Troy is a legal policy advisor, has been chipping away at the FDA’s power to control drug advertising for years. In addition to its DDMAC Watch, the WLF files amicus briefs in cases where off-label allegations are made. The WLF has even defended drug execs who have blinded their patients by arguing that the off-label law is unconstitutional.

The move by GSK to appoint Troy is a fascinating one, because it again raises the question of how aggressively drug companies want to challenge FDA’s authority to regulate what they do. (At one time, Pfizer also employed a WLF sympathizer.)

GSK’s answer seems to be, more aggressive than ever.