The agency will hold a public hearing Nov. 1 and 2 in Washington to discuss the issue. Some think the hearings could lead to the first-ever formal regulations for DTC promotions.
"I think the general consensus is that the FDA, this time, will finally produce something of substance," said a chief marketing officer for a major drug maker.
In September 2003, the FDA heard input during a two-day public hearing and said it would produce guidelines for the industry within six months, but no rules ever materialized. This past August, looking to stave off government intervention, the major pharma companies adopted a code of conduct for DTC established by their umbrella trade group, the Pharmaceutical Research and Manufacturers of America. Several individual drug makers, including Bristol-Myers Squibb and Pfizer, earlier this year instituted their own internal DTC policies.
A PhRMA spokesman said the group will speak at the public hearing.
The expectation that the FDA will produce "something of substance" has merit. Both the pharmaceutical industry and the FDA are under heavy scrutiny from politicians and the public. The tipping point came a year ago, when Merck's arthritis drug Vioxx was pulled from the market after it was found to increase risk of heart attacks. Many critics claimed Vioxx's marketing blitz contributed to its over-prescribing.
Also, FDA Commissioner Lester Crawford abruptly resigned Sept. 23, only two months after being confirmed by the Senate, and some are hoping that his replacement, Acting Commissioner Dr. Andrew C. von Eschenbach, will be tougher than his predecessor.
Sen. Charles Grassley, R-Iowa, who has been in dogged pursuit of the industry and DTC for more than a year, said: "In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information."
The FDA did not return calls for comment, but its 6,000-word announcement of a public hearing in the Sept. 13 Federal Register did offer some insight. At one point, in describing the purpose and scope of the hearing, the announcement read: "FDA is holding this hearing because it believes the agency, the industry and other members of the public now have enough experience with DTC promotion to understand what regulatory issues may need to be addressed in new FDA activities."
It also appears the FDA will question whether the use of celebrity endorsers of prescription medications should be banned.
"Such approaches plainly do not reflect a data-oriented approach to promotion and may not be recognized by consumers as anecdotes," the agency wrote. "FDA is interested in whether and how techniques mislead consumers about the risk-benefit tradeoffs of prescription or restricted medical products."