INTRODUCTION

Snake oil, anyone?

Believe it or not, there was a time when those who manufactured patent "medicines" were completely unregulated. They could market their product directly to patients making any claim they wished, without any safety information, and without any repercussions. Crazy, but true! Thus, the birth of the proverbial term "snake oil," which is, according to the Oxford English Dictionary, "a quack remed or panacea."

Luckily, we’ve come a long way over the past 150 years…

Key Milestones in Drug Marketing Regulation ^{1, 2, 3}

1906: The Pure Food and Drug Act

requires drug manufacturers to maintain purity levels, list the active ingredients on the packaging, and not manufacture, sell, or transport products that are "adulterated, misbranded, or poisonous"

1912: The Sherley Amendment

prohibits false therapeutic claims on drug labeling

1930: The FDA is Named

the US Bureau of Chemistry is split into two agencies, one of which is named the Food and Drug Administration (FDA)

1938: Food, Drug, and Cosmetic Act (FDCA)

requires that drugs have to be proven safe and receive the FDA’s approval before they can be marketed

1951: Durham-Humphrey Amendment

defines the kinds of drugs that cannot be used without medical supervision/ requires a prescription by a licensed practitioner

1962: Kefauver-Harris Amendment

prescription drug safety and effectiveness must be proven through clinical trials and approved by the FDA; FDA controls and regulates prescription drug labeling and advertising; off-patent (generic) drugs cannot be relabeled and priced as new medications

1966: Fair Packaging and Labeling Act

requires all consumer products to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices

1969: FDA promulgated its final advertising regulations

requires advertisements to present a "true statement of information in brief summary relating to side effects, contraindications, and effectiveness"

1997: Food and Drug Administration Modernization Act (FDAMA)

includes measures to regulate advertising of unapproved uses of approved drugs and devices

1999: FDA Final Guidance for Prescription Drug Broadcast Advertising

ensures consumers get a balanced view of the benefits and risks of a product

The impact of this regulatory evolution in the Life Sciences industry resulted in a shift from 100% direct-to-consumer (DTC) prescription drug advertising in the first half of the 20th Century to marketing and selling almost exclusively to doctors by 1960.⁴ With this change, the pharmaceutical sales rep was born.

From the 1950s to the early 1980s, biopharmaceutical companies invested solely in indirect marketing via sales reps, advertising in medical journals, continued medical education events, and other marketing programs targeting healthcare providers (HCPs).

However, in the early 1980s, political and social shifts led the industry back to DTC marketing. DTC advertising started with print and television campaigns to increase awareness of underdiagnosed conditions, sponsored by pharma companies, followed by direct product advertisements. In the mid-1990s, DTC marketing expanded and flourished online, as the world turned to the internet as their primary source of information.

Fast forward to today, and you have a complex mix of direct-to-consumer and direct-to-HCP marketing through a myriad of channels that didn’t even exist 5, 10, or 20 years ago, alongside armies of pharmaceutical sales reps out in the field, all operating in one of the most highly-regulated environments in the world.

This intricate web of marketing influence has many benefits, but also has introduced some new challenges. This eBook explores these benefits and challenges and digs deep into the one challenge that has led to a critical gap in pharmaceutical omnichannel marketing.

With growing competition from similar or virtually identical products manufactured by different
companies, the importance of favorable interpersonal
relationships has become
increasingly important...

RR Rehder
Communication and Opinion
Formation in a Medical
Community: The Significance of
the Detail Man, Academy of
Management Journal, 1965

Footnotes:

1 https://www.fda.gov/about-fda/fda-history
2 https://blog.hubspot.com/marketing/pharmaceutical-marketing-history
3 https://www.fda.gov/media/109482/download
4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690298/