Senate Majority Leader Bill Frist (R-Tenn.) called on companies to voluntarily drop DTC advertising for two years after the approval of new drugs.
In a speech delivered on the floor of the Senate, Frist suggested that ads "are fuel to America's skyrocketing drug costs" and called for a Government Accountability Office study on the possiblity of expanding Food and Drug Administration oversight powers to allow for prior review and approval authority over all DTC ads.
The GAO has taken a generally favorable view of DTC in the past. In October, 2002, the office issued a report on drug advertising finding that while ads increase spending on drugs, companies spend far more on R&D than on promotion. That report scolded some companies for airing misleading ads while taking the FDA to task for poor responsiveness.
The most prominent medical professional in public life, heart-and-lung transplant surgeon Frist is reacting to concerns from fellow physicians, a spokesman for the senator told USA Today. His remarks come days after Bristol-Myers Squibb adopted a one-year moratorium on DTC ads for new products. The timing of the speech -- on the Friday before the three-day Fourth of July weekend -- ensures maximum coverage, while its lateness in the congressional calendar suggests little legislative action on the issue this year.
Advertising Coalition counsel Jim Davidson told MM&M: "The fact that the majority leader put this on the table raises the debate. It's a shot across the bow, and it's going to get the attention of the pharmaceutical and advertising industries, asking them to take matters into their own hands."
Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson responded to Frist's speech in a statement issued this afternoon. "Direct-to-consumer advertising plays an invaluable role informing physicians and patients of new and life-saving medicines," said Johnson. "Evidence does not link advertising and drug prices." PhRMA has stepped up work on an advertising code of conduct for its member companies.
In prepared remarks, Frist said: "In recent years, spending on direct-to-consumer advertising of prescription drugs has skyrocketed. This advertising can lead to inappropriate prescribing and fuel prescription drug spending. It can also oversell benefits and undersell risks. Used appropriately, direct-to-consumer advertising can empower patients without inflating need or distorting medical realities. But research evidence indicates that this blitz in direct marketing has unwittingly led to inappropriate prescribing, which most importantly can compromise patient safety and care.
"That's why I'm calling for pharmaceutical companies to implement a voluntary two year restriction on direct-to-consumer advertising efforts for newly released drugs. Furthermore, I'm requesting that the General Accountability Office analyze the FDA's oversight of prescription drug advertising, the pharmaceutical industry's spending on such advertising, and the potential impact on utilization, health care spending, patient education and awareness.
"Failure to appropriately monitor and regulate direct-to-consumer drug advertising compromises the safety of the very patients we intend to help. I encourage the industry to allow doctors and patients alike to learn more about the potential benefits and risks of new treatments, so we can be sure we are putting the needs, interests and safety of our patients first."