This article was published on Buzzfeed Community on June 5, 2017
When did you start seeing ads on TV for prescription drugs? Probably the early 1990s right? This isn't a coincidence. In the early 90s the Food and Drug administration (FDA) lowered regulations on advertising to consumers. All of a sudden ads for prescription drugs started popping up everywhere. Why did this happen? In the early 90s, rising premiums coupled with a economic recession drove employers to start reconsidering the way they make money. Before this time Pharmaceutical companies advertised solely to doctors. A lack of trust in doctors had been forming and allowed drug companies to come in and find a way to get their products to the consumer. The problem goes further however. In the 1970s the patients right act was passed. This law focused on doctors, mainly because businesses were not a threat to the patient at the time. the Law of patients rights does not seek to give patient's knowledge. Instead it accepts inequality and forces fiduciary duties onto physicians. It forces doctors to use their skills only in the patients best interest and provide services that meet professionally accepted standards. However, businesses do not have fiduciary obligations to their consumers.
However, businesses do not have fiduciary obligations to their consumers.
Unfortunately, loose regulations have allowed DTCPA to run rampant. The FDA does not require the ads for approval before they are used. In 1997, the FDA issued draft guidance on this topic (and final regulations in 1999) that allowed broadcast DTC product claim ads to include a “major statement” and “adequate provision” to satisfy the “fair balance” requirement, rather than the lengthier “brief summary,” which listed all product risks. This was quickly followed by drug companies only listing major risks associated with taking a drug. You could direct consumers to a brief summary of the drug via a phone number of website. Although the relaxation of FDA rules in 1997 might not have been totally responsible for the rapid growth of DTC drug advertising, it did have an impact on the most preferred media for DTCPA. It was television.
Money spent on DTCA through the years
There is difficulty in enforcing and taking action against drug companies that violate regulations from the FDA. The FDA's capacity to enforce these regulations has weakened substantially. Recently, the number of regulatory actions taken by the FDA has decreased dramatically. Some say that this could be a result of more companies following regulation.. However the FDA has an extremely small staff for reviewing thousands of drug ads. In 2009, only 59 full-time employees were reportedly responsible for reviewing 71,759 industry submissions of both DTCPA and DTP promotional material, and they could cope with only a fraction of them.
In 2009, only 59 full-time employees were reportedly responsible for reviewing 71,759 industry submissions of both DTCPA and DTP promotional material, and they could cope with only a fraction of them.
Trends in enforcement of DTCA regulations over the years
There have been several attempts to ban DTCPA In 2015 the American Medical Association called for a ban on the ads. The doctors are concerned that the increase in ads is driving up the cost prescription drugs. Especially considering the facts that there are drugs that are just as clinically effective and cost less to the patient. One doctor stated, "Patient care can be compromised and delayed when prescription drugs are unaffordable and subject to coverage limitations by the patient’s health plan. In a worst-case scenario, patients forego necessary treatments when drugs are too expensive.”
Opposition is met to these calls. One of the main arguments is that of free speech. the argument relates to commercial speech and states that banning them violates the first amendment of freedom of speech. In 1980, the court developed a set of criteria for determining whether a ban on commercial speech is allowed. This test examines whether the advertising is misleading, whether banning it directly advances a substantial government interest (e.g., preserving public health), and whether the government’s interest could be achieved through a less restrictive route, such as by adding a special label.
The strongest arguments for Direct to Consumer includes empowering patients and encouraging them to go the doctor. Seeing these advertisements can cause people to understand symptoms of a disease they have and go to the doctor to receive help. Most of the time however, patients will go to the doctor and ask for the drug. American physicians deemed half of Direct to Consumer requests inappropriate but fulfilled 70% of the requests for fear of losing the patient. You don't want your doctor to feel pressured to make a decision that may not be appropriate for you.
However, Drug ads can misinform patients. More often than not the ads will omit crucial information. For example, in one study, 82% of DTCPA ads made some factual claims and rational arguments for use of the advertised drug; however, only 26% of the ads described risk factors or causes of the condition, and only 25% mentioned prevalence. Consumers have also been found to place unwarranted trust in DTC ads.5 One survey of consumers found that 50% of respondents thought that the ads were approved by the government, 43% thought that a medication had to be completely safe for it to be advertised; and 22% thought that a drug known to have serious side effects could not be advertised. It is also said that the ads can put a strain on the doctor patient relationship. doctor's claim that these ads can undermine their authority and force them to spend time explaining to the patient why a certain medication is clinically appropriate rather then spending time trying to find the right medication.
Solutions have been offered up but don't seem to make it past. Some of these solutions include forcing the advertisements to be approved by the FDA before they are aired. Other solutions include simplifying the language used in ads so that they are more understandable to the population. Another option is to include the cost of the drug. Yet you still have to wonder, why are the US and New Zealand the only two. Why do we allow these ads and other major countries don't? If we are able to regulate these ads it could mean good news for the American Healthcare system.
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