FDA Update on Advertising and Promotion of Prescription Drugs

Thomas Abrams, R.Ph., M.B.A.Division of Drug Marketing, Advertising, and CommunicationsFood and Drug AdministrationJanuary 30, 2006

Topics

Policy Updates Enforcement Updates 2006 and beyond

DDMAC’s Mission

To protect the public health by assuring prescription drug promotion is truthful, balanced, and accurately communicated

Policy Updates

Direct-to-Consumer Promotion (DTC) Risk Information Guidance Development

Direct-to-Consumer Promotion

Increasing interest Concerns about DTC PhRMA and Industry Actions FDA Actions

FDA Actions and DTC

Research on DTC conducted Sept 2003 – Public Meeting held on DTC

research Feb 2004 – 3 draft guidances issued Nov 2004 – DTC Research Final Report Nov 2005 – DTC Part 15 Meeting held

Risk Information

Most common violation cited in DDMAC’s letters

Important to public health American public entitled to balanced picture

Risk Information

Industry– make efforts to better present risk info– include serious and common risks

cannot omit risk from promotion

FDA– working on draft guidance for risk info presentation– taking necessary and appropriate enforcement

actions

Guidance Development

Presentation of Risk Information Brief Summary: Disclosing Risk Information

in Consumer-Directed Print Advertisements (Brief Summary)

Help-seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firm (Help-seeking)

Enforcement Analysis

15 Warning Letters in 2005 vs 4-5 WLs average of previous years

Stopped and corrected misleading promotion Actions needed to achieve compliance

Types of Violations - Most Common

Inadequate Risk Information - 82% Misleading Effectiveness Claims - 43% Misleading Comparative Claims - 43%

Targeted Audience

Healthcare Professional Directed - 60% Consumer Directed - 30% Both HCP and Consumer Directed - 10%

Violations concerning Risk Information

Nipent Warning Letter Survanta Warning Letter

Nipent Warning Letter

Booth panel and handout Overstatement of safety and efficacy Failed to present any risk information Boxed Warnings about severe renal, liver,

pulmonary, and CNS toxicities Untitled letter in 1997 – risk Untitled letter in 2001 – misleading claims

Nipent Warning Letter

Overstatement of Safety– Nipent is selectively cytotoxic to the leukemic

population, exhibiting little or no effect on stem cells

– Unsubstantiated and contradicts PI (use of drug is associated with multiple hematologic cytopenias)

Omission of risk information

Survanta Warning Letter

Direct mailer to healthcare professionals Effectiveness claims

– Large, colorful, bolded headers– colorful charts– bullet points

Risk information – small font in two lines at very bottom of page 3 of 4-page

promotional piece– below the references and footnotes

Misleading Effectiveness Claims

Quadramet Warning Letter

Quadramet Warning Letter

DTC radio ad, patient testimonial video, and website

Overstatement of effectiveness Omission and minimization of risk information

– Bone marrow suppression– Radioactivity in excreted urine

Quadramet Warning Letter

Quadramet doesn’t make you lose your hair, it targets the cancer and that is what so great about it. It knows where to go. I think it is amazing.

Quadramet travels to the site of bone reformation due to metastatic bone cancer to provide relief with a single injection.

After the Quadramet shot started to take effect, she was back to her old self, she wasn’t drowsy.

And I am surprised that she didn’t sit here and cook a big meal for you guys.

Misleading Comparative Claims

Lumigan Warning Letter Remodulin Warning Letter

Lumigan Warning Letter

Sales aid Unsubstantiated superiority claims

– Weight of evidence proves LUMIGAN produces lowest mean IOP. For example…vs beta-blockers … vs travoprost… vs latanoprost… vs dual therapy

– Lumigan produces lowest mean IOP…vs dual therapy 14% to 27% greater mean IOP reduction than Cosopt

Remodulin Warning Letter

Journal ad and FAQ booklet Misleading comparative claims to Flolan

– Answer to “How is Remodulin different than Flolan” highlights advantages of Remodulin’s method of administration (subcutaneous vs. central infusion)

– “Can I Switch From Flolan to Remodulin?” “Yes in fact there were published results … where patients were successfully switched from Flolan to Remodulin.”

Both presentations fail to reveal material facts -- that Flolan has a proven effect on walking distance and survival in indicated patient population while Remodulin has not demonstrated these benefits

Promotion of Unapproved Uses

Cubicin Warning Letter

Cubicin Warning Letter

Journal advertisement and website Broadens the indication

– treatment of all infections caused by Staph aureus

PI states it is not indicated for pneumonia– In Phase 3 studies of community-acquired

pneumonia, death rate was higher

Correctives

Same audience and similar vehicle Correct misleading messages Examples – print ad, DHCP letter

Plans for 2006 - DTC

Part 15 Analysis and Follow Up PhRMA Guiding Principles

– Increase in number of submissions of proposals

Advisory comments Guidance Development

Plans for 2006 –Guidance Development and Voluntary Compliance

Guidance Development– Presentation of Risk Information– Help-Seeking Communications– Brief Summary research

Voluntary Compliance– Guidance– Advisory Comments– Outreach

Plans for 2006 - Enforcement

Continue close monitoring and oversight of prescription drug promotion

Take appropriate actions to ensure compliance

Continue efforts to encourage voluntary compliance

DDMAC Information Phone numbers:

– Phone - (301) 796-1200– Fax - (301) 796-9877 and (301) 796-9878

Web addresses:– www.fda.gov/cder/ddmac– Warning and untitled letters : Posted on

www.fda.gov/cder/warn– Guidances: Posted on www.fda.gov/cder/guidance