Daily Archives: November 21, 2017

Glossary Building Post – 5

These final terms come from the Pharma Slides.

The first term is NDA. NDA stands for New Drug Application. Even after reading what the acronym stood for, I still had no idea what this meant. According to the FDA page on NDA’s, this stands for

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

The goals of the NDA are to provide the drug reviewer with information to assess the drug in safety, benefits vs. risks, if the labeling is appropriate and whether the manufacturing methods preserve the drug’s identity, strength, quality and purity (Center for Drug Evaluation and Research). I believe that this term is important for consumers because in a way, it makes sure that companies advise and report everything about the given drug from clinical trials to ingredients and safety to packaging. Without this information, the FDA cannot approve a new drug and this is what keeps consumers safe and large companies from selling just about anything.

The next term is product claim. This is one of three drug advertisement methods. Product claim advertisements are very straightforward. They name a drug and explain which conditions/diseases the drug can treat. Reminder ads only give a drug’s name but not the use and help-seeking ads discuss a disease/condition but doesn’t make any recommendations on which drugs to take to help with treatment.

I think it’s important that all consumers know all of these drug advertisement methods. While they all serve different purposes, essentially, they all get consumers thinking “Do I have that?” “Do I need that?” “I should ask my doctor what is typically used to treat ____.” “I wonder what that drug is used for?”

  • New Drug Application: The vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
  • Product Claim Ad: Names a drug and explains the conditions it treats.
  • Reminder Ad: Only gives drug’s name but not use.
  • Help-Seeking Ad: Explains a disease/condition but doesn’t make any recommendations on which drugs to take.

 

Sources

Center for Drug Evaluation and Research. (n.d.). New Drug Application (NDA). Retrieved

November 21, 2017, from

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm

Center for Drug Evaluation and Research. (n.d.). Prescription Drug Advertising – Sample

Prescription Drug Advertisements. Retrieved November 21, 2017, from

https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm168421.htm

Pharma Slides

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Pharmaceutical Industry

Prompt 2

There are three links I find relevant on the FDA website about DTC prescription drug advertisement:

  1. Background on Drug Advertisement
  2. Basics of Drug Ads
  3. Sample Prescription Drug Advertisement

The Background on Drug Advertisement is important and consumer friendly because it goes over the FDA’s purpose

The Food and Drug Administration (FDA) protects public health by assuring the safety, effectiveness, and security of a wide range of products, including human prescription drugs. We also advance public health by helping people get the accurate, science-based information they need to use medicines appropriately and improve their health.

which I believe is reassuring to consumers. This link also goes over the FDA overseeing advertisement on drugs to make sure that the ads are not misleading. At the very end of this section it is clarified that this website is not to expose ads that may potentially violate laws but rather give an explanation of ideas and concepts related to drug advertising.

The Basics of Drug Ads section explains the difference between over-the-counter and prescription only drugs. This section also goes over the different forms of advertisements and what is included and not in the advertisement, for instance, drug name rather than drug use.

The Sample Prescription Drug Advertisement section is very consumer friendly in that, it provides three different examples of correct and incorrect advertisements:

  1. Product Claim Ad: Names a drug and explains the conditions it treats.
  2. Reminder Ad: Only gives drug’s name but not use.
  3. Help-Seeking Ad: Explains a disease/condition but doesn’t make any recommendations on which drugs to take.

It is important for the consumer to know the difference between these advertisements and what they look like in order to be informed.

From the readings and pharma slides, consumers might still be at risk because today more people are getting exposed through advertisements and becoming interested in DTC prescription drugs. Now they also have a choice between generic and original – price difference – and ‘me too’ drugs which are similar to existing generic drugs with little to no additional benefits.

 

Sources

Center for Drug Evaluation and Research. (n.d.). Prescription Drug Advertising – Sample

Prescription Drug Advertisements. Retrieved November 21, 2017, from

https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm168421.htm

Pharma Slides

PhotoVoice – 1

For my PhotoVoice project I will be answering the questions: How healthy is it? Who’s selling me what? Do I really know what I need to in order to make a healthy choice? and Why is it so difficult to be healthy/easy to be healthy?

I think that all of these questions go hand in hand. I will most likely use power point to display images as well as short clips of various foods, menu’s, and perhaps even nutrition facts provided by restaurants. Normally, I don’t eat out so I might also include home cooked meals and with thanksgiving around the corner, making healthier choices as well as eating healthier will be a challenge!

Pharmaceutical Industry Prompts/Prompt Two

Direct To Consumers (DTC) is one of the big ways the Pharmaceutical Industry gets people to be aware of their new drugs.   This is done majority of the time through television and probably the Internet also.  DTC striked my attention as I never thought about pharmaceutical advertising since I am not taking any prescription drugs and hope to stay that way.    The following pie chart shows all different ways that a drug(s) is marketed.

pharm-mktg-grab3

Source:   http://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharmaceutical-industry-marketing-and-its-influence-on-physicians-and-patients

The following is another example from the World Health Organization (WHO) which caught my attention as I never thought about endorsers as being actors.   I probably don’t recognize all the actors as I do not watch much television.  “In the USA, Democrats in the United States Congress challenged the industry’s use of direct-to-consumer advertising in January 2008, when Congress announced an investigation of several advertisements including the one featuring Robert Jarvik rowing a boat for Pfizer’s cholesterol-lowering Lipitor. A month later Pfizer pulled the ad and Pfizer’s president of worldwide pharmaceutical operations, Ian Read, expressed regret about people getting the wrong impression. Ten months later the pharmaceutical industry announced that it was updating its voluntary standards for direct-to-consumer advertising. It pledged to stop using actors to play doctors, and to make sure endorsers who said they had used a particular drug had actually done so.”

I agree that the endorser who has actually used the drug should advertise so they can talk about their actual experience and this would definitely be consumer friendly.  People would appreciate the advertisements more and possibly use this particular drug also.

Source:  http://www.who.int/bulletin/volumes/87/8/09-040809/en/

Consumers are still at risk because the following title and example about how much is spent in advertising; I think this is one of the big reasons: “Persuading the Prescribers: Pharmaceutical Industry Marketing and its Influence on Physicians and Patients.   In 2012, the pharmaceutical industry spent more than $27 billion on drug promotion— more than $24 billion on marketing to physicians and over $3 billion on advertising to consumers (mainly through television commercials).  This approach is designed to promote drug companies’ products by influencing doctors’ prescribing practices.”

Source:  http://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharmaceutical-industry-marketing-and-its-influence-on-physicians-and-patients

The links through the slides page also mentions that once patent period is gone; other companies make generic form that drug.   This is also in debate though it saves consumers monies who cannot afford expensive drugs.

So in my opinion, if you eat mostly plant-based diet from the time you are young, you can avoid so much of the drug taking.   Of course, along with exercise, limiting processed foods, and junk foods even if they are plant based ingredients.   Many of my friends have changed their diet so can other people.