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... solve serious problem of misleading drug advertising. The changes include several measures. First of all there were increase in FDA actions as to illegal advertising. The next step was concerning with Congressional decision to provide large fines on companies for violating the drug advertising law.
And the final change was made by legal authority. It required all TV ads to be confirmed by the FDA before they air. During a long period of time PhRA constantly improved its technology. It adopted some principles for direct-to-consumer advertising, which were based on receiving comments from health care professionals and the general public about DTCA. Lets examine some principles.
First of all the information, receiving from DTC, should be true and accurate. It is regulated with FDA and should be marked with. its approved labeling. The balance between risks and benefits should be presented. As to the advertising on TV and in newspapers, there is the main demand, that it should be educational one, not only with comercial purpose. It should teach the consumer how and when he can use the medicine.
It should be distinguished which drugs are for free sell and which ones must be sold under a prescription. Later on some kind of communication bridges was created to take more complete information directly from health care professionals. It was the aim to help patients achieve better health care. One of the Fda's demands is that all new DTC advertisement should be submited with it. This step has to be fulfilled for reducing the violation of general concepts and for supplying customers with available and legal information. the seriousness of health conditions is of the primary importance.
Thats why All DTC advertising should pay attention on health conditions, for which the medicine is approved, and point the major risks associated with it. But there is one of the main problems with medicine advertisement on TV. There are some messages that are not, for example, for children. How to avoid those audiences?
The question is widely discussed at present. Though there are many obstacles, but pharmaceutical companies consider its very profitable to advertise their products on TV and newspapers. A good example for it is Johnson & Johnson company. It has adopted Ph RMA Guidelines on Direct-to-Consumer Advertising and succesfully follow the guidelines. As a rule there is always an alternative, even for some of the greatest rejects. Is there an alternative for DTC guidelines of Ph RMA?
Having known from the previous material, that DTC strategy ames to educate not only doctors but patients, and give viable information about medicine taken, the alternative should have a task, concentrated on separate actions of physicians and pharmaceutical companies. Some pharmaceutical marketing chiefs think that self-regulation is better than to allow someone else to tell you how to manage your business. May be they are right, because the medical profession from the beginning is one of the few shirts that are traditionally based on self-regulation. It is impossible to buy a prescription drug without a doctor's signature.
During the last period of time this self-regulation standard have been changed in some points. First of all they were extended and reflects the interactions between physicians and professional organizations. From the other point of view, direct-to-consumer (DTC) advertising is considered to be misleading by several public leaders. They say that new Ph RMA guideline was an attempt, without any practical importance. They pointed that using DTC is a meaningless attempt.
But lets just take into about the inner policy, conducting with the FDA. For more than 40 years the company regulated prescription drug ads. But its based on drug industry self-regulation failed. May be it happened, because the fundamental purposes of the company were not taken into account, while selling drugs. Phrma's strategy with DTC advertising is the best way to increase benefits and to reduce the risks. Though both guidelines, latest of industry self-regulation and DTC guidelines of presence, are both dangerous, because can fail, new strategy has proved its effectiveness.
Take the entire Side-Fx program, as an example. It was created with pharmaceutical companies. It took into account Ph RMA Marketing Code. It proves that providing clinically relevant rapports are useful for organising medical practice for professionals.
By the way, Side-Fx helps to manage the practice of medicine and at the same time gives a substantial benefit to patients. DTC strategy was created in the Side-Fx book and DVD with the purpose to meet all needs of medical practice and patients awareness about medecine's used. But new guidelines had no clear measures for violation of the guidelines. By the way, it needs some limited period of time between the process of a drug's approval by the FDA, and while a patient can use it. New guidelines could not apear without definite pre- conditions. As it was pointed that the Ph RMA organised voluntary line, for determining public opinion as to its new strategy.
And from the latest statistic data, customers call for companies to educate patients about diseases. It will play an important role in increasing responsibility of the pharmaceutical companies while promoting their medicines. In spite of that, there are some preventative measures (exercise and diet), which can increase risk. To avoid the danger of it, patients should constantly be informed and warn about risk. It encourages doctors to get information about new drugs; and they can estimate and give professional coments of benefits and risk while using the medicine. But, unfortunately, the company does not prepare clear measures that will be taken in a case of violation some ethic and moral principles. (The only ones are those regulated by the FDA).
When Ph RMA presented a new set of guidelines, it called for a great wave of skepticism. From the one hand it was because of more data from clinical trials should be made. From the other side the do not give enough information while accounting. Criticism from Congress increased, and the pharmaceutical industry decided to treat to public opinion, with tha aim to weigh all advantages and disadvantages of new guidelines, and to take a support of customers.
The guidelines was also developed by Ph RMA for working to educate health-care professionals. Till the time they had no opportunity to know more about new products. At present they can gate full information about products, approved by the FDA. Having a chance to know more about the product before meeting with audience on TV programm, doctors can explain some difficult and safety information in clear, understandable language.
It is known that many pharmaceutical companies agree to start working according to the their consumer-advertising practices immediately. They think new guidelines will be useful for both pharmaceutical institutions, physicians and customers (patients). Mutual benefit will be the main rule for interacting. It gives constant profit for pharmaceutical institutions.
Physicians will be given necessary information about any type of drugs. It will help them to be morally independent from gifts, supplying by pharmaceutical institutions. And clients will be saticefired, because they can not only get necessary information, but to become more educated in this field. But it is clear, that a client (patient) is of the greatest importance. Thats why Ph RMA will open an internal office. There it will receive comments from the public and health-care professionals.
The company is going to organise an independent review board in 2007. Its main task will be to review the effect of the guidelines and see if they need updating. By the way, the FDA is going to give more power and resources to consumer groups as well as to public citizen. So, with all these means they will be able to regulate consumer ads the pharmaceutical industry. I think that new guidelines serves to improve practical implementation of the principles.
Thats why the new policy of the company may be called voluntary. It runs clear of specific proscriptions or prohibitions Frankly speaking, it is difficult to decide which guideline is better and more viable. In real life we see that DTC ads become more frequently shown on TV and printing in newspapers. What kind of effect do they make on our consciousness? Do we really become more medical educated?
Unfortunately, not. For the last decades pharmaceutical industry made a great progress in invention of new drugs. I strongly believe, that if you want to know the real risk of the certain medicine, you should follow its impact on, at least of, two generations. So, how can we talk about real risk or benefit made with drugs.
We had an opportunity to see after-effects. And, by the way, it is known, that every person differs from others. So, what is good for one man may be a death for another. So, as to me, I prefer to believe a doctor. Bibliography: Door, Jennifer. US: Drug Industry Creates Voluntary Ad Guidelines.
Corp Watch, 2005 Edwards, Jim. Ph RMA Unveils New Guidelines. Daily pharmaceutical news, 2005 Park, Paula. Ph RMA urges more disclosure. The Scientist, 2004 web web >. New Compliance Requirements Facing Pharmaceutical Companies Under California's SB 1765 By John P.
Knave [August 2005 ] THE WALL STREET JOURNAL Drug Firms Address Furor on Tests [print edition: Drug Makers Urged to Publish Data] New Guidance on Results Aims to Calm Concerns Over Negative Trial Data By SCOTT HENSLEY June 30, 2004; Page D 7 web Editorial, Op-Ed Address New Voluntary Guidelines for Direct-To-Consumer Prescription Drug Advertisements, USA Category: Pharma Industry News Article Date: 07 Aug 2005 Daily pharmaceutical news Drug Industry Prescribes Self-Regulation Topics: marketing | lobbying | health Source: New York Times, May 17, 2005 AMA Journal discussion. Self-Regulation and the Relationship of Physicians with the Pharmaceutical Industry by Justin M. Thomas Mar 31, 2005
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