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Food and Drug Administration (FDA)

Essay Topic: ,

Traditionally, the drugs were marketed towards the doctors and there was a limit to the direct to consumer marketing. This was because of the fact that television advertising for such products was highly expensive. The expensiveness of these television commercials was due to the regulations of the Food and Drug Administration (FDA).

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Prior to 1997, all direct-to-consumer advertisements that contained a medical claim and brand name had to have a brief summary of drugs effectiveness, side effects and contraindications.

But in the August of 1997, Food and Drug Administration allowed the advertising of drugs without a brief summary, though a major statement still had to be added, which had to educate the consumer about the major risk and refer him to other sources for detailed information. They were number of departures from the requirements under the Food, Drug, and Cosmetic Act of 1938, which had prohibited the use of print and television media for advertising prescription drugs. This change in the regulation brought about a change in the promotional activities of the drugs manufacturing companies.

There was an increase in the advertising expenses of these pharmaceutical companies from a mere US $ 800 in 1997 to about US $29. 8 billion in 2007. The supporters of the direct-to-consumer advertising emphasis that, such promotions help the consumer in understanding the symptoms of many under-diagnosed diseases. While the opponents of the same believe that such advertising would mislead patient towards demanding heavily promoted drugs, leading to inappropriate drug usage and unnecessary purchase of comparatively expensive products.

The advertising being used today has a lot of influence on the consumer, but does this advertising actually help the consumer or does it mislead them to a disaster. Mr. Brain Storm, professor and chair of biostatistics, epidemiology, and medicine at the University of Pennsylvania School of Medicine, has termed Direct-to-Consumer marketing as “a disaster”. He while addressing the issue said that the public should not be given such kind of information as the drugs are difficult for the patients to understand.

Further he added that dosing is even a harder job and finally, the assessment of a disease is best done by a doctor. He assured that the patients were not at all qualified to make an assessment of what drug they need. And so the information leads to no benefits for the patients but a lot of harm. Over the years many drugs have only been available for the consumers on the prescription of a medical consultant only, the reason behind such a restriction was that all the drugs that have the ability to heal, could also be harmful.

The doctors, nurses and other health professionals get trained and have the experience to help them decide whether drugs are suited for a particular patient or not. And so they carry all the authority to take the decision for the prescription of a drug to any patient. Advertising of such prescription drugs has increased the pressure on the doctors and other health professionals to recommend particular medications which are often more expensive and dangerous yet less effective.

This is an intrusion in the relationship between a doctor and patient, and so would disturb the therapeutic process. Further the doctor now has to give the patient reasons why certain advertisement could have misled him into the use of the drug, or why could the patient use a certain prescription under the circumstances. Studies have shown that Direct-to-Consumer-Advertising information does not provide patients the complete information, rather the information provided is biased “education.”

It has been observed, according to (Woloshin S, Schwartz LM, Tremmel J, et al: Direct-to-consumer advertisements for prescription drugs: What are Americans being sold? ) that 87 percent of television advertisements presented the potential benefits of medications in vague, qualitative terms that were not backed by scientific data. A massive campaign was launched by Takeda Pharmaceuticals North America in the summer of 2006, the campaign was targeted to the insomniacs and suggested that the drug Rozerem, could reunite them with the dreams that were waiting for them.

This campaign was joined in with other campaigns, all targeted to the consumers directly. Today, a typical American television viewer has to watch around 16 hours of such directly targeted advertisements in a year (Frosch et al, 2007). The consumer groups such as US Public Interest Research Group want the Food and Drug Administration to act bit more responsibly, so that consumers cannot be harmed through misled ads. The direct-to-consumer advertisements have been a new entrance to the world of advertising.

This is a major reason for the lack of trust in such commercials. The case of the drug Vioxx could be taken as one of the stories which support the argument. Merck introduced an anti-inflammatory drug by the name Vioxx, the drug became a blockbuster drug with the sales exceeding US $ 1 billion. All this occurred due to the television commercials targeted towards the consumers. Later, it was known that the drug had increased the number of patients with strokes, heart attacks and so the drug was removed from the market (Donohue et al, 2007).

Although the Pharmaceutical Research and Manufacturers of America have made guidelines for the DTCA (direct-to-consumer-advertising), yet it has been observed that critics such as AIDS Healthcare Foundation argue that the self regulation has not been functioning well and the companies continue to start advertising for the product with the one year of the approval from FDA (AIDS Health Foundation 2007). According to a study conducted in Baltimore, the 46% of the consumers who had watched a DTC for certain product would get disappointed if they were not provided the same drug by the practitioner.

While 25% said that would try to influence their doctor to change the mind, while the remaining 15% thought that they would switch the doctor. All these factors suggest that the use of DTC is actually creating complexity in the minds of the consumers. DTC has clearly increased the sales of drugs, or they have actually increased the number of drugs that have been prescribed, but the question that has to get answered is whether these drugs are essential for the consumers or are they just wastage of the scarce resources in the economy.

According tot eh doctors, a drug is thought to have efficiency if the positive impacts of its use out number the negative connotations. Under these situations it is of great importance that the correct drug is prescribed. Another factor that has been raised due to the use of DTC has been the increase in the prices of the DTC advertised products that cost more than the generic drugs available in the market. These ads present biased appeals to the masses to influence decisions about drugs that are designed to be approved within the context of a relationship between a knowledgeable professional and a person who is known as an individual.

The professional has a complete historical knowledge about the patient and does know about anything present in the drug that might cause a problem to the patient. On the other hand when the same patient requests the use of another product that had been advertised, it becomes difficult for the doctor to explain to his patient that the drug has a different purpose, and so wastes around 40% of the doctors precious time just to explain that the drug that was been prescribed was much better than the one being advertised.

One unintentional effect of the DTC would be the worsening of inequalities in health and heath care. Research has shown reduced understanding of DTC ads for viewers with limited literacy and lower health knowledge, raising the concern that the effect of ads would increase disparities. Conclusion: The study that was done tried to explore the different pros and cons of the direct-to-consumer marketing on the consumer’s choice for the prescription of the drug.

It was seen that the consumers are naïve about the use of the drugs and could be easily manipulated by the pharmaceutical companies through the misleading information in the advertisements or the incomplete information. Therefore, it is of utmost need that the authorities like PhRMA and FDA take serious steps towards consumer protection. On the other hand, it was observed that it is not the use of advertising was not being done to educate the consumer; it was rather being done to increase the profitability of the organizations.

Had it been other way round, the companies would not mind using the generic names. The pharmaceutical organizations are trying to increase the market size; this increase in the market size would automatically mean an increase in the potential customers, and so higher revenues over the years for the companies. The drugs that are being advertised are being sold at even higher cost, suggesting that these drugs are of a superior quality, although that is not the case.

Proper research is lacking as within a period of one year the drug are advertised leading to the sales. Proper trust in this form has to be inculcated, and that would be possible only if the pharmaceutical companies act more responsibly and instead of trying to generate only profits also work for the betterment of humanity. The long term impact of DTC need greater in depth studies and would require extensive research, but it would be worthwhile to do so, given the enormous stakes of public health and huge sums of money involved.