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US FDA "must improve drug ad policies," says govt agency
The US Food and Drug Administration is failing to protect consumers from misleading prescription drug ads, according to a damning new report from the Government Accountability Office which also sharply criticises the agency for failing to make improvements which it had requested in 2002.
During 1997-2005, drugmakers' spending on direct-to-consumer advertising increased twice as fast as the amounts which they spent on promoting their products to doctors or on R&D, and the industry's total DTC ad spend for 2005 reached $4.2 billion, says the GAO. The Office's investigation suggests that DTC advertising has contributed to increased drug spending and utilization, for example, by prompting consumers to request the advertised drugs from their physicians, "who are generally responsive to these requests," it says, but I also believes that the effect of DTC ads on consumers can be both positive - by for example encouraging them to talk to their doctors - and negative, eg, increasing the use of advertised drugs even though alternatives may be more appropriate.
The GAO says the FDA reviews only a small portion of the DTC materials it receives and that it has "informal criteria" to identify materials that have the greatest potential to impact public health. However, it adds, the FDA has not documented these criteria, nor does it apply them systematically to all the materials it receives or track information on its reviews. "As a result, the agency cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority," it warns.
The GAO is particularly damning in its assessment of the effects of a change in FDA policy introduced in 2002, which required all warning letters concerning unacceptable drug ads to go through the agency's Office of the General Counsel for legal review. As a result of this change, during 2002-5 the agency took four months, on average, to issue a regulatory letter, compared with the average two weeks it took during 1997-2001.
The FDA has issued about half as many regulatory letters per year since the 2002 policy change and the effectiveness of these letters has been limited, the report adds. The 19 letters issued in 2004 and 2005 appeared an average of eight months after the ads had first appeared and, by the time the letters were issued, companies had already halted use of almost half of them.
The policy is also failing to stop repeat offenders, says the GAO. "When the cited materials were still being disseminated, drug companies complied with FDA's requests to remove the materials, and identified and removed other materials with similar claims," it notes. However, it adds: "FDA's issuance of regulatory letters did not always prevent drug companies from later disseminating similar violative materials for the same drugs."
Issues aren't new, says GAO
"These issues are not new," the GAO comments; in 2002, it had told the FDA that the policy change had adversely affected its ability to enforce compliance and that it could potentially allow misleading ads to continue, and the FDA had accepted the Office's call for it to issue the letters more quickly. The new report again urges the FDA to reduce the time it takes to issue warning letter, and also says the agency should develop formal guidelines for its review of ads.
FDA spokesmen responded that it was incorrect to state that the agency did not consider DTC materials which should have the highest priority; it reviews all final and draft broadcast ads because these have the greatest potential impact, they said. Implementing the GAO's recommendations would require significant staffing increases, they added,
The Pharmaceutical Research and Manufacturers of America (PhRMA) pointed out that the study had examined the period before the PhRMA adopted its Guiding Principles on DTC Advertising in January 2006. However, added PhRMA senior vice president Ken Johnson, comments from the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) have suggested that PhRMA member companies have made positive changes since then and are taking their commitment to the Principles very seriously.
"In fact, it has been reported that since the DTC Advertising Principles took effect, there has been an increase in communication between the FDA and PhRMA member companies to help ensure that prescription drug advertisements continue to provide useful, balanced and educational information about diseases and available treatments," he said.
$51bn spent on R&D
Mr Johnson also corrected the report's statement that the US drug industry spent $31.4 billion on R&D in 2005, pointing out that the total was in fact more than $51 billon. It was also misleading for the GAO to suggest that DTC advertising leads to an increase in prescription drug prices, said Mr Johnson; according to the Federal Trade Commission, there is no correlation between the two, he noted.
The GAO had been asked to conduct the study by three Senators, two of whom are Republican - outgoing Majority Leader Bill Frist and outgoing Finance Committee chairman Chuck Grassley - plus Democrat Herb Kohl, who is set to take over as chairman of the Senate Special Committee on Aging after January 4, the day on which the Republican party officially hands over control of Congress to the Democrats. The day after the report appeared, Sen Kohl wrote to President George W Bush asking that his budget request for 2008 should include extra funding to enable effective review of DTC advertising by the FDA.
"Americans are bombarded by direct-to-consumer ads every day, yet this report makes it clear that the FDA's effort to police those ads is inadequate," said Sen Kohl.
Sen Grassley said he was sponsoring legislation to require drugmakers to submit advertising campaigns to the FDA before launch, while Sen Frist, a doctor, commented: "Americans are besieged today with advertising for prescription medications. Therefore, it is necessary for Congress to fully review the advertising practices of the pharmaceutical industry and federal regulatory practices to ensure patients are getting safe and effective prescription drug treatment."
By Lynne Taylor
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