FDA Is Slow To Issue Warnings On DTC Ads
1 CommentBy Ed Silverman // May 13th, 2008 // 6:59 am
The FDA continues to be slow in sending warning or untitled letters when the agency suspects drugmakers violated DTC rules, according to a report by the Government Accountability Office, FDAnews reports.
Last year, the agency took an average of six months to issue regulatory letters citing DTC violations, Marcia Crosse, who heads the GAO’s healthcare division, told a House subcommittee last week. In one case, the agency took more than three years to issue a regulatory letter, FDAnews notes.
Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review — a policy for which there was no apparent need — it took less than a month to send such letters, Crosse told the committee. (Here’s her testimony).
The FDA hasn’t improved since 2006, when the GAO found that “by the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter,” according to the latest GAO report accompanying Crosse’s testimony. “In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”
Moreover, only two regulatory letters were issued in 2007 compared with as many as 25 letters each year between 1997 and 2001, before the legal review policy, FDAnews writes. Meanwhile, the FDA “has received a steadily increasing number of advertising materials directed to consumers,” according to the GAO report, which tallied about 6,000 in 1999 and 21,000 last year.
Dan
Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state and the commercial is sponsored usually by a big pharmaceutical company for a particular network. This is called direct to consumer advertising, and doctors would prefer they did not exist.
Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns. And involves money spent that could be applied to greater uses, according t many, but we are dealing with a corporation here.
The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective, which is to increase sales and grow their market and, in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe to be medical flaws, and illustrated by the creators through exaggeration and embellishments through media sources as an avenue for suc propaganda, as is often seen with DTC advertising. Yet the flaws may not be medical, but corporate creations of these questionable human ailments that do not require treatment, possibly, and may be an attempt to develop a particular medical condition to acquire profit. One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.
Also, DTC ads discuss only one treatment option normally, so it seems, when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the doctor, as they assess your health, not your television or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of our country and New Zealand.
Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome for the doctor chosen for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription.
Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some over-prescribing, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which is far from financial prosperity.
“Men of ill judgment oft ignore the good that lies within their hands till they have lost it”
Sophocles