What about some "Regulatory affairs in the US and EU" - Part IX of X

Preface: I have been absent. Loads of work in the lab, loads of writing at home, gym to prepare my body for two lovely weeks some-when in August (the south of Portugal is my destination), and the so addictive UEFA Euro 2012 - Go Pooooortuugalllll! But I am pretty much done with most of it, still hoping Portugal to beat Spain tonight and proceed to the FINAL! Something else that is reaching its end? Our long review on PTI's Regulatory Affairs course.

Let's go...

What is reviewed in the ninth module?

"Module Nine looks at the area of advertising/promotion in the pharmaceutical industry. Provides an introduction to the promotion of medicines and discusses the changing views of the public towards direct-to-consumer advertising. More detail at the different styles of regulation and strategies that are required in the US."


Expect a lot on the different agencies that are involved in regulating promotion and advertising of pharmaceutical products; also good information about the self-regulating systems and some hints on the legal requirements to comply with the set demands.

What about funny and curious facts revealed in this module?

Examples of poor publicity affecting pharmaceutical companies are provided at the start. The given examples are common in certain countries but they have been under rigorous scrutiny lately. Tell me someone who has never heard of a doctor who've been to loads of conferences and suspicious trips, and suddenly the news report on this guy to be related to the constant prescription of X, Y and Z pharmaceuticals. But this part of the module initially also eyes the intricate world of unnecessarily prescribing medicines and bombarding people with futile drugs. 

About promoting products I fancy the solid posture of UK's MHRA (Medicines and Healthcare products Regulatory Agency): "It will not tolerate advertising, whether this is written or spoken, which has the potential to mislead healthcare professionals or the public and it is not afraid to publicly name and shame any companies who abuse the legislation or ignore its guidance."

Section 7 of PhRMA's code of practice clearly establishes a maximum value of $100 as "the limit ... for items used to help educate patients".

Find here the link for the Prescription Medicines Code of Practice Authority.

What about some awesome quality information?

"The methods for regulating promotion/advertising of medicines differ vastly from country to country and it is important to be aware of these changes when reviewing or designing promotional material."

Regarding promoting, the European Federation of Pharmaceutical Industries and Associations (EFPIA) code is probably the clearest and most understandable. The 14 articles to which the 29 EU countries need to address before making any decisions are very comprehensible. From these 14 articles I'd personally like to stress 3 of them that are really important to highlight:

- Sponsorship of healthcare professionals,
- Gifts and inducements,
- No advice on personal medical matters.


Also the self-regulating optional to adhere code of practice from the Association of the British Pharmaceutical Industry (ABPI) is a must for the United Kingdom, and it seems to be a step forward on clauses that should definitively be applied in the most recent member states.

In the UK ABPI examines Representatives of companies in regards to the Code.


The Pharmaceutical Research and Manufacturers of America (PhRMA) is the American version of ABPI and also has an active code of practice consisting of 15 principles.

Is there anything missing?

It isn't properly missing due to a laps in memory from the author, but because it is extremely difficult to determine what is promotion and what might touch it softly yet still be acceptable. The author tries to provide us with examples but for someone reading it for the first time it will take its toll. In this sense I believe that legal requirements presented by European Union are, however, a lot clearer after the directive 2001/83/EC (as amended).

About the representatives, usually called Reps): "No gifts, (including monetary) unless they are inexpensive & relevant to practice". Again, not the author's fault but, how do one judges what's an expensive gift. Is it a £200 netbook expensive, is a £15 Parker Pen expensive, is there a threshold for the price of what you are offering?

Check here to see a great example of a breach in the code of practice five counts in a row. ABPI was on the case and now it's here for you to see.

Next week I'll bring the last part of this great revision on PTI's introductory course "Regulatory Affairs in the US and EU". Tomorrow, however, something new is to air here in The Toxicologist Today, an insight on a software I have been using for nutrition control and other food matters. I believe you guys are going to appreciate the analysis.

And the label Profiles is cooking a brand new interview. This time questions flew all the way to Ghana, hope it to air later next week.

See you soon, guys.

Image taken from InPharm, [http://www.inpharm.com/news/110121/boehringer-pradaxa-advertising-abpi-code], last access on the 27th of June 2012, last update on the 21st of January 2011.