Promotion and Marketing of Prescription Drugs

Lesley R. Frank, Ph.D., J.D.FDA-DDMAC

September 23, 2004

What is DDMAC?

FDA’s Division of Drug Marketing, Advertising, and Communications

DDMAC’s Mission: To protect the public health by assuring prescription drug promotion is truthful, balanced, and accurately communicated

Functions of DDMAC

Ensure compliance with FFD&C Act Not false Not misleading Balance between risks and benefits

Voluntary Compliance Enforcement Action

Voluntary Compliance

Guidance documents Comments when requested Clarifications of issues and

questions

“Promotional” Labeling

Brochures, booklets, mailing pieces, file cards, bulletins, calendars, price lists, catalogs, letters, videos, slides, exhibits, and similar pieces of printed, audio, or visual matter descriptive of a prescription drug

Advertising

Advertising -- published journals, magazines, and other periodicals, newspapers, broadcast through media such as television, radio, and telephone communications

Standards for Labeling and Advertising

May recommend and suggest the drug ONLY for those uses contained in the approved product labeling

May not be false, lacking in fair balance, or otherwise misleading

Prescription drugs are unique -- the law requires disclosures of the consequences of using the drug

What’s False or Misleading

Better or more effective than indicated Safer (fewer side effects, lower

severity, incidence) Comparative claims (better/safer than

other products) w/o substantial evidence

Misleading presentation of data, risk relative to benefit, etc.

Types of Promotion

Help seeking (“see your doctor,” disease oriented) -- these are NOT drug ads

Types of Promotion

Reminder -- regulations specifically exempt from disclosure requirements; includes name of product, but no representations beyond dosage form and packaging, price information not for products with especially

serious (“boxed”) warnings

Types of Promotion Product claim

claims or representations trigger requirements for accuracy and balance

risk disclosure requirement

Enforcement

Surveillance Disseminated materials submitted

to FDA Post-marketing reporting

requirements (Form 2253) Conference attendance Complaints Surveillance including websites, TV

ads, and journal ads

Enforcement Options

Untitled letters Warning Letters Injunctions/consent decrees Seizures

Examples of Violations

Minimization or ineffective communication of important risk information

Promotion of unapproved uses or drugs

Unsubstantiated claims of efficacy or safety

Unsubstantiated comparative claims

Examples (con’t)

Reminder ads with product representations

Overstated claims re: likelihood of benefit, especially for products with relatively low efficacy

Effexor XR/Effexor Untitled Letter

Professional and DTC promotion Professional pieces claimed that

drug is more effective than SSRIs Cited meta-analysis is not substantial

evidence

Effexor (cont.)

“…how’re you feeling these days? Okay? Not bad? Come on, is that where you want to be?...”

Effexor (cont.)

DTC radio ad omitted common adverse events (e.g., sexual side effects, dry mouth)

Ad broadened indication Failed to distinguish between normal

periodic feelings of low interest/low energy and major depressive disorder

Taxotere Warning Letter DTC print ads Overstated survival benefits: Headline:

“The next move may be the key to survival” Proven survival differences were at best several

months and were only observed in specific populations

Other drugs with proven survival benefits Unsupported outcomes claims

Stay involved in important aspects of your life

Taxotere WL (cont.) Omission of risk information

Boxed warning information on risk of life-threatening infections, severe allergic reactions, and severe fluid retention

Certain common side effects

Minimization of risk Risk information lacked visual prominence Began “Like all anticancer agents, there are

side effects…”

DDMAC Information

Web address: http://www.fda.gov/cder/ddmac Warning and untitled letters : Posted on

www.fda.gov/cder/warn Phone numbers:

(301) 827-2831 or (301) 827-2828 Fax number:

(301) 594-6771