It’s October, the beginning of cold and flu season.  A new Yale study is released linking PPA, an ingredient in many cough/cold products, to hemorrhagic stroke (bleeding in the brain), particularly in young women.  After hearing the Yale results, a Food & Drug Administration advisory committee recommends re-classifying PPA as unsafe on October 19, 2000.  SmithKline Beecham (SB) learns that the FDA will act quickly.  They activate the company’s crisis plan and call on Ketchum to position SB as a leader in addressing FDA’s response--thus protecting its Contac brand’s reputation and minimizing impact on sales.  


SB’s Contac cold medicine was among more than 400 products containing PPA.  Ketchum was called on October 25 to quickly mobilize communications in anticipation of the FDA’s possible actions.  On November 6, just 12 business days since the advisory committee recommendation, the FDA issued a Public Health Advisory requesting that manufacturers stop marketing products containing PPA and asking consumers to stop using PPA-containing products.  It was imperative to clearly communicate that only one out of six current Contac formulations (capsules) contained PPA.  Some lots of previously discontinued Contac formulations possibly still on store shelves/in medicine cabinets also contained PPA, making communications difficult.


Ketchum’s research provided timely information to support our counsel, and to supplement the SB crisis plan:

Analyzed media coverage daily to identify trends/issues and help shape tactics.

Monitored related Web sites, i.e. FDA, and legal Web sites seeking PPA clients.  

Conducted informal telephone and in-person surveys of local pharmacists regarding their awareness of the issue and to confirm consumers were relying on them for information.  

Key Finding: Although not formally notified by FDA, pharmacists were aware of the issue through the media and were receiving significant consumer inquiries about products.

Researched competitor response via media monitoring, 800# calls, and review of Web sites and advertising.  Key Finding: Not prepared to respond, competitors took several days to initiate similar SB actions, and they also spent additional dollars on reactive advertising.

Solicited pharmacist input on a direct mailing package and Contac Web site enhancement. Key Finding: They confirmed the value and content of the communications.

Initiated Opinion Research Corporation Omnibus telephone survey of 1,015 adults.  

Key Findings: At seven weeks past advisory announcement, unaided awareness of PPA issue was still very high at 50 percent; awareness among Contac users was even higher at 74 percent; in terms of what actions to take this cold season, most frequent response was to ask their doctor or pharmacist for advice. 


As SB’s crisis agency of record, Ketchum had developed a comprehensive crisis communications plan that established key duties and protocols to be used in a crisis. The crisis plan and advance planning enabled SB to be ahead of all competitors in being prepared for this crisis.  Prior to the FDA advisory, potential FDA response scenarios were mapped and corresponding action plans and communications materials were prepared proactively so that SB would be ready the minute the FDA made an announcement.  Communications during the remainder of the crisis period were revised and implemented based on research results.  

Target Audiences: Contac users, general public, trades (sales force and retailers/wholesalers), media, pharmacists.        

Strategy: Utilize and adapt the crisis plan to mitigate negative publicity and sales impact, as well as to protect the brand’s and SB’s reputation.

Objectives: Minimize impact on Contac market share.

Position SB as a leader in complying with and exceeding expectation of the FDA Advisory, by being the first to announce voluntary withdrawal from store shelves.

Help ensure only affected lots of Contac were removed from retail shelves/warehouses and returned to SB.  (It would have been easier for retailers to remove all Contac product from shelves, leaving none available for consumer purchase, thus causing substantial impact to SB through lost sales revenue and cost of non-PPA goods returned.)


PPA activities from October 25 through the end of December in chronological order included:

Preparation of a confidential Q&A for internal use, responding verbally to media inquiries, and as a basis for the consumer hotline script.

Preparation of key message points, reactive press statement and letters to trades.

Identification of proper medical spokesperson and media training.

Seven days per week, round-the-clock media monitoring and analysis to monitor PPA-related activity internationally and to help shape media messages and the tactical plan.  Out of approximately 50 total reports, 12 were provided to client in the first five days.

Participation in SB PPA team conference calls (2-3 times/day initially, then 1 time daily).

Development of consumer Contac Web site copy regarding PPA and the Contac product line. 

Tracking competitors’ advisory reactions, consumer messaging and reformulation plans.  

Recommendation and development of pharmacist-specific communications (direct mailing and special pharmacist area on Contac Web site) to help address consumer confusion.  

Development and implementation of an Omnibus consumer survey to evaluate how the PPA issue is impacting public opinion and purchase decisions. 

Analysis of Omnibus results to provide client with recommendations for future marketing.


Objective 1:  Minimize impact on Contac market share.

Although other manufacturers lost market share after withdrawing PPA-containing products, Contac maintained its share average of 1.90 according to November/December Nielsen data. 

The majority of Contac users included in the Omnibus survey indicated that they would continue to buy the Contac brand in a PPA-free formulation.

Objective 2:  Position SB as a leader in complying with and exceeding expectation of the FDA Advisory, by being the first to announce voluntary withdrawal from store shelves.

SB key messages were included in 78 percent of the first week’s media coverage.  

An AP editorial on Nov. 11 recognized SB as a leader: “Hopefully, all drug manufacturers will follow SB’s lead and remove the PPA risk from store shelves and consumers.”

SB was the first manufacturer to proactively provide a toll-free hotline to address consumer concerns about its PPA-containing products.  During the first week, 2,000 calls were received regarding PPA and Contac.  

Contac’s Web site saw a 40 percent increase in visits from October to November.

Objective 3:  Help ensure only affected lots of Contac were removed from retail shelves/warehouses and returned to SB.

In December 2000, an audit of more than 1,400 retail stores showed only 4 percent had capsules remaining on shelf, indicating retailers removed most of the affected product.

While detailed return data will not be available for 6-12 months, an assumption can be made that unaffected product was not removed from shelves, as sales have remained steady.
An analysis of initial calls to SB’s toll-free hotline showed that 80 percent of consumers who called about Contac were not confused.  They knew they had a PPA-containing product, clearly indicating key message delivery through media coverage and minimizing requests for unnecessary product returns.