A cadre of about 12 Senators and House members is reviewing the issue four years after the U.S. Food & Drug Administration loosened its regulations unleashing the rash of broadcast ads, according to a person involved in the process. Michael Shaw, executive editor of EthicAid, whom legislator have consulted on the matter, said they may move individually or as a unit to introduce legislation as soon as this fall. EthicAd is an Atlanta-based nonprofit group that seeks to promote DTC as a public health benefit, meaning it wants to work with the industry to support the advertising but at the same time ensure consumers are protected.
An aide to Sen. Russell Feingold, D-Wis., confirmed that meetings have been held on the topic.
Concepts under discussion include increasing funding so the FDA can hire more staff to review DTC ads and establishing a quasi-governmental advisory panel to develop standards for the ads, which the drug industry and the FDA would be encouraged to follow, Mr. Shaw and others said. Any legislation is not expected to seek to directly impose any rules for DTC ad content.
Mr. Shaw said his sense is that members of Congress prefer not to move ahead with legislation. However, they want to use the threat of it to encourage the drug industry not to abuse DTC and take a bigger role in developing increased standards for the ads as a form of self-regulation. "They want to register their concern and give the industry fair warning that they expect it to take this issue seriously and that they have a social responsibility," Mr. Shaw said.
Meredith Art, a spokeswoman for the trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), said the industry believes effective safeguards are in place. "Direct-to-consumer advertising is already strictly regulated by the FDA," she said. "We've always complied with the Food & Drug Administration."
The FDA has 13 people responsible for reviewing tens of thousands of promotional items each year, ranging from handouts at professional conferences to ads broadcast during the Academy Awards, and the agency believes it is understaffed.
Within the DTC category, the FDA reviewed nearly 450 TV ads in 2000. Some legislators believe DTC has gotten out of control, leading to both the over-prescribing of certain drugs and more expensive drug costs (as drug companies look for more money to pay for all the advertising).
"Obviously, they're concerned about the cost and they're concerned about the impact this is having, if any, on the public health," said one government official familiar with the matter. "Some of them are very concerned about how this is impacting vulnerable populations such as the elderly and people who may not be that educated and might be overly influenced by the advertising."
The issue is gaining steam thanks to talk on Capitol Hill of establishing a prescription-drug benefit for Medicare users. That would mean the government would bear the ever-increasing drug costs. DTC ads have mushroomed along with costs; consultancy IMS Health said the category generated $2.5 billion in spending last year, a 35% increase over spending in 1999.
The issue is being raised as the U.S. Supreme Court prepares to hear oral arguments April 25 in an appeal of a Massachusetts tobacco case that raises questions about what steps the government
can take to limit advertising for legal products.
The FDA will re-examine its 1997 ruling to loosen requirements for broadcast ads later this year but is not expected to make significant alterations. Congressional involvement, which would be separate from that process, would mark a new chapter in DTC-especially if it leads to public hearings.
Other than Sen. Feingold, it is unclear exactly who the dozen or so legislators pursuing the matter are; Mr. Shaw declined comment. One person familiar with the matter cited James McGovern, a little-known Massachusetts congressional representative. Both Sen. Feingold, known for campaign finance reform, and Rep. McGovern are Democrats, but another person close to the matter said interest is bipartisan. An aide for Rep. McGovern said the representative is interested in the topic but would not take a lead role in writing legislation.
It's questionable whether any bill would gain widespread support in Congress. Additionally, the Bush administration is expected to take a stance favorable to large pharmaceutical companies and would be able to thwart legislation. (During last fall's presidential race, then-Vice President Al Gore cited increased ad spending as one of the contributing factors leading to rising drug costs, even mentioning Schering-Plough Corp.'s Claritin as an example of an overly advertised product.)
Also in the way is the powerful PhRMA, which would wage a furious fight against limits on DTC, since its members feel it has given them a beneficial new marketing option. Ms. Art, the PhRMA spokeswoman, said the group was not aware of any legislation in the works.
But even if stand-alone DTC legislation is not passed this year, government oversight of DTC could be affected in 2002, when legislation that establishes the user fees drug companies pay the government for approval requests to market new drugs comes up for reauthorization. Negotiations between the pharmaceutical industry and Congress with FDA involvement are expected to start this year, and one person close to the matter said the FDA may push for drug companies to pay additional user fees to fund more surveillance of marketing materials, including DTC.
"You could introduce the bill, maybe have a hearing if the [committee] chairman is willing and pop it into the [fee act] next year," a person involved in the process said.