Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
cder cder20096 television and radio conspicuous neutral manner dtc advertisements
2010-06-08 2010-05-24 2010-04-19 2012-04-12 2012-03-27 2012-04-12 2012-02-16
FDA-2009-N-0582-0024 FDA-2009-N-0582-0022 FDA-2009-N-0582-0014 FDA-2009-N-0582-0058 FDA-2009-N-0582-0056 FDA-2009-N-0582-0057 FDA-2009-N-0582-0047
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https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0024 https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0022 https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0014 https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0058 https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0056 https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0057 https://api.regulations.gov/v4/comments/FDA-2009-N-0582-0047
Anonymous Anonymous Anonymous Marty Amanda Audrey Lacey
Anonymous Anonymous Anonymous Pace Darnell Johnson Mccauley
Nice idea but an utter waste.  Lawmakers must learn medication selection involves a complex assessment based on patients current health and medication use. Medicine is different from McDonalds in this way; you cannot accomplish such education concerning possible side effects or life threatening risks in a 30 second ad spot intended mainly  to sell you on the benefits. There is no way to give patients enough information to make an informed decision.  DTC ads merely encourage people to go ask for the latest drug (which  is often an over-priced me-too drug at that) because they saw it on TV. Caveat emptor, indeed.  The new rules are fine but will prove to be as ineffective as the previous ones. Due to the short length of most commercial advertisments for new and exisiting drugs, I do not feel like there can be enough control of advertising claims.  Consumers already deal with endless numbers of drug and device recalls.  Possible side effects and device malfunctions should be clearly stated. FDA looked to rules of other agencies, including the Federal Trade Commission, the Securities and Exchange Commission and others who had previously interpreted clear and conspicuous in a similar fashion. As to defining a neutral manner, the Agency noted it was unaware of similar regulatory precedent and determined that it would interpret neutral to mean unbiased. To achieve a neutral and unbiased presentation, it said the major statement must not be presented in competition with other elements if these elements would arrest the attention and distract consumers from the presentation of the risk information.Significantly, the Agency did not propose that the major statement be included in both audio and visual parts of the advertisement, even though it said it thought such a standard could enhance the clarity, conspicuousness and neutrality of the major statement. While to a great degree the Agency has already been utilizing similar criteria to determine whether a broadcast DTC advertisement is false and/or misleading, the new standards set forth in greater detail the approach FDA will utilize in reviewing broadcast DTC advertisement for prescription drugs. While it is not, as FDA says a set formula, it does provide a roadmap as to how advertisers can satisfy FDA that their advertisements effectively communicate the overall message of a major statement. I will have agree with the FDA in setting these additional standards with some additional clarifications to how this would be implemented, because Drug companies are using all means to attract the consumers to many dangerous drugs even though the doctor may not agree with however the consumer would insist on trying such drugs because of the way it was presented to him in such a believable manner. I am all for having clearer understanding in drug related commercials.  Too often the person describing the drug goes through the side effects so quickly you never hear what they say. I also believe the hide the side effects with images that take away from what the drug can do to you. The writing in magazine advertisements should be much larger, one should know what the drug can do to them without them being hidden.  I feel this rule would help in a lot of ways. It would force the pharmaceutical companies that advertise on television or the radio to clearly let people know of the risks and side effects of taking their prescription drug and not to distort any of the negative side effects. This would allow the consumers watching/listening to the drug ads to have a better understanding of the risks involved in taking the drug they are considering to try before they purchase the drug or to be left to find out firsthand the side effects by actually taking the prescription drug. By making the pharmaceutical companies state the side effects both verbally and visually more people are apt to hear/see the side effects. People will no longer miss the small print at the bottom of the screen while being more focused on the happy people enjoying their day because of the drug showing in the background or listening to the happy tune playing. I feel as though this rule would have a positive impact both on the consumers by keeping them well informed of the prescriptions drugs they are thinking of using and on the pharmaceutical companies actually advertising the drug because it will keep them honest and most likely get more people to try their drug. I know I would be more likely to try a prescription drug that would help me if I knew of all of the negative side effects that could happen before trying it than a prescription drug I knew almost nothing about.  I would like to comment on this new regulation on Direct-to-consumer prescription drug advertisements. As many state that they believe that this is a waste of money as well as non-educational information to an audience who probably will not pay attention, I believe that this will help the general public gain more knowledge of what prescribed medications are available to them. Making sure that advertisements have a clear, conspicuous, and neutral manner will ensure viewers that they are getting the correct information. Seeing a commercial that is only interested in sky rocketing sales and misleading the public into believing their medication is the best for them when it truly is not occurs well too often than it should. It is very common to see people smiling and jumping for joy, moving to upbeat music while bright colors and an excited public audience show a beautiful, healthy world. This information is purely for selling and does not prove that any medication is proven to work accurately or be the best for any patient. Also, fine print and quick communication of negative side effects at the end of the commercial do not help the public to know all aspects of the prescription drug. This is purely unfair and misleading to the public. I believe that if money is going to be spent on a prescription drug advertisement, it should be spent knowing that the advertisement works at its best to the general publics advantage and is not misleading in any way, shape, or form. All advertisements should be educational when they are about something as serious as a prescription drug as patients need whats best for their well-being, not a turn around. I conclude my comment expressing my agreement with these regulations. I do believe this will work to our advantage and will be a great help to society. Food and Drug AdministrationFDA-2009-N-0582, and RIN 0910-AG27While I do feel that this rule could be beneficial to the general public, as possible consumers to these prescription drugs, I cannot make a set judgment on the overall effectiveness without first knowing the FDAs detailed standards for determining whether this regulation would be met.I certainly agree that advertisers often use distractive tactics to subdue the otherwise startling effects of the side effects being listed. However, the commercial is advertising the drug with the purpose of selling it.  While we can continually raise the standards of drug companies to fully explain the possible side effects in a 30 second blurb, it seems more reasonable to expect a certain level of responsibility on the consumer to request this information when they speak to their doctor.