Regulation of Marketing and Promotion in Pharmaceuticals

Promotion of medicines

all informational and persuasive activities by manufacturers and/or distributors where the intention is to induce the prescription, supply, purchase and / or use of medicinal products

Under General Principles of Regulating Promotion and Advertising , promotional activities and materials should be

• –  accurate

• –  truthful

• –  reliable

• –  informative

• –  Balanced (Concept of “fair balance”)

• –  up-to-date

• –  capable of substantiation

• –  in “good taste”

Under General Principles of Regulating Promotion and Advertising -any comparisons to other products should be

* factual, fair and substantiable

Under General Principles of Regulating Promotion and Advertising , products should not

• contain misleading information or omissions

• be designed to mislead, take advantage or disguise their real nature

General Principles of Regulating Promotion and Advertising - min info requirements

• The approved brand name

• Name and amount per-dosage-unit of the active ingredient(s)

• Names of any other ingredients know to cause medical issues (e.g. allergens)

• Approved therapeutic indications / uses

• Dosage form and/or treatment regimen

• Any major adverse drug reactions and / or side effects

• Precautions, contra-indications and mandated warnings

• Name and address of manufacturer

• Reference to scientific literature where appropriate

* In EU States, advertising of medicinal products is

* “controlled” by a combination of regulations

Advertising

any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products

Advertising to the general public should not include

prescription drugs

Arguments in favour of Direct to consumer (DTC) Marketing

• Informs, educates, and empowers patients

• Encourages patients to contact their clinician and promotes dialogue

• Encourages patient compliance

• Reduces underdiagnosis and undertreatment of conditions

• Reduces stigma

• Encourage competition and lower prices

Arguments in opposition of Direct to Consumer (DT)C Marketing

• Misinforms patients (Dunning-Kruger Effect / “Expert Syndrome”)

• Overemphasises benefits

• Novelty becomes a selling point (rather than a drawback)

• Medicalisation and disease “manufacture”

• Creates tension/strain in HCP-patient relationships

• Promotes poor / inappropriate prescribing practices

• Increases costs (engineered obsolescence of generics)

Opiods

Most important group of medicines for pain relief

Examples of Synthetic Opeids

• Codeine

• Fentanyl

• Hydrocodone

• Methadone

• Oxycodone

What is Carfentanil

• First synthesized in a lab in 1974 (Brand name Wildnil)

• Potent animal tranquilizer (for large animals such as elephants)

• NOT APPROVED ANYWHERE FOR USE IN HUMANS

• One of the most powerful opioids created (100x > fentanyl, 10,000x >morphine)

• Linked to a significant number of overdose deaths across the country

• Increasingly “cut” with heroin and other street drugs

• Large manufacturing operations in China