ByJeremy Cohen

FDA

• First Introduced in 1906

• Division of Drug

Marketing, Advertising, and

Communications (DDMAC)

• Center for Devices and Radiological

Health (CDRH)

• Impose Regulations on Ads

DTC ADS pre 1997

• Limited Use by Pharmaceutical Companies

• Applied to Any form of Broad Cast Media

• Ads required 2 Distinct Parts

–“Brief Summary”

–“Fair Balance Doctrine”

DTC ADS Post 1999

• Required “Adequate Provision Statement” rather than “Brief Statement”

• FDA issues Final Guidance for Industry, Consumer-Directed Broadcast Advertisements in August 1999

– Disclosure with 1-800 number

– Reference to Another form of Media

– Disclosure of A Web Address

– Disclosure of Where to find Additional Information

Multimedia Marketing Creates PMDD???

DTC ADS With A Twist

• New advertising scheme utilizes 2

different ads

• Ads under 30 seconds each separated by

commercial

• Stand alone Ads

• First Ad is “Help seeking”

• Second Ad is “Reminder”

Help Seeking Ad

1. Person not Product

2. Identifies Symptoms

3. Seek Help

4. Company Name

Reminder Ad

1. No Condition

2. Drug Name

2007 Time to Change Again..

• FDA issues the FDAAA or FDA

Amendments Act of 2007

• Major Statement includes

–Simplified language

–Audio easy to understand

–Text utilized clear easy to read

–No distractions

2009 the FDC

Act, FDAAA, FTC, DOT, SEC

• New rule proposed Amendments to DTC regulations

• Side effects and contraindications must be

–Clear

–Conspicuous

–Neutral

Misleading Bond…..

DTC Ads and VNR’s

• Social Media Networks

–Facebook

–My Space

–YouTube

–Blog Spot

• VNR Video News Release

• Control???

Social Media Ads….The Future ??

What's Missing??

When you need a little help getting to sleep…..

When what you ate for dinner didn't agree…

When your chest and throat feel like they are on fire….

When you need a little lift….

Pharmaceutical Branding

How many of these can you name?

Lunesta PeptoBismul

Nexium Viagra

Pharmaceutical Branding

•What Next??