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Not-So-Sweet Story of the FDA and Saccharin
Instructive and milestone in how FDA handles crises
How NOT to handle a crisis:
· February 1977: Press office learned proposed ban to be announced
o Lack of Planning: agency leadership feared discussion of plans would leak
§ Result: Allegations public handling was deliberate effort by FDA to sabotage Delaney Clause
· Press Release:
o Rats in the study consumed amount of saccharin in 800 soda bottles/day
o Signaled incorrectly: FDA did not want to ban Saccharin but had to because of Delaney Anti-Cancer Clause
o Drafted morning issued
§ 1 paragraph and 1 editorial change
§ little thought on how it should have been worded
· Press Conference:
o Held March 9th, 5:30PM
o Same time Hanafi Muslims holding hostages in 3 buildings in downtown Washington
§ No cameras allowing FDA to explain situation directly to public
· Reporters ignorant: stories reflected this
§ Would have been better to hold it next day
· Press Release:
o Failed to explain properly high dose animal studies
§ This proved to be Achilles heel
· 800 bottle a day statement used to ridicule study
· *Must explain science to media and public!
· Congressmen:
o None issued statements supported intended FDA action
§ FDA Failed to notify congress
· If congress isn’t notified in advance of what you’re plans are, they won’t support them
· Industry:
o Agency failed to alert them
o Had not seen Canadian study ban was based on (no direct knowledge)
§ Could legitimately attack action as premature
· Special Interest Groups:
o Ex: Diabetes Associations
o Also weren’t briefed
· Most Significant:
o Agency released study and announced action in same day
§ Result:
· Moving saccharin debate dramatically into a crisis situation
· Agency will not more that quickly on any new study
Article 31:
The Tylenol Crisis
Key Facts:
· Began Sept. 29th, 1982
o First 7 Deaths from cyanide-laced Tylenol capsules
o In Total, Unidentified Psychopathic Killer laced 44 Extra-Strength Tylenol capsules
§ Alleged extortion attempts against Johnson & Johnson (health care products giant whose subsidiary, McNeil Consumer Products Co, manufactures Tylenol
§ Reports of “hard-core, true tamperings” posed problems for government and corporate managements
Identify PR Problems:
· Before Major problems (all the killings)
o Factfinder: Lawrence Foster (J&J’s VP of PR)
§ Mcneil’s use of cyanide in manufacturing process: NO
· Journalistic sense: Incomplete truthà media relations problem
o After deaths Chicago authorities checked reports of psychosomatic illnesses and Tylenol related rumors
§ Unconfirmed news report: (rumor not known by foster until Sat. Oct. 2nd/ 2 days after first Tylenol death)
· Cyanide was used as analytical agent to test both Tylenol raw materials and finished product
§ Media verified despite j& J’s attempts to explain presence of “small quantity” in lab for testing
· àJ&J’s credibility tarnished
o no corporate PR staffer knew
§ later discovered tampering occurred at retail level
· Tylenol Recall
o Quickly (2nd day of crisis, Oct. 1st: 6th death) recalled millions of bottles in US & Abroad
o Spent $½ million warning physicians, hospitals, and distributers
o Product advertising stopped
o J&J’s Top management group met 2x/day during crisis
§ Would public link Mcneil to J&J (not promotionally identified together)?
· Possible consequence: negative repercussions by millions of J&J product consumers, 38,200 stockholders, loss of moral of 77,000 employees
o “communications media monster” 80,000 US Newspaper stories in 3 days, hundreds of hours of national and local television radio coverage
§ before: 250 media contact during 78, 337 in 79, 573 in 80, 687 in 81, 401 in first half of 82: unprecedented in 97 years of J&J
§ Nov. 11th national news conference
· J&J chairman & chief exec. Officer: Burke
o “90% of American public knew that only Tylenol capsules, not tablets, involved. (Young & Rubicam surveys showed) 93% public believed ‘problem could occur for any capsule’ and 90% felt maker not to blame’”
Surveys:
· consumer attitudes on using Tylenol with “new triple safety-sealed tamper-resistant” packaging
· Shapiro survey data suggested need to step up promotional efforts for purely defensive purposes (Feb. 18th)
o Foreshadowed 3 months earlier by Foster who disclosed $4 million spent on national coupon ads (sales promotion)
§ “thank you America for your continuing confidence and support_”: redeemable for $2.50 towards Tylenol product purchase (telephone toll-free number for coupon)
Final results:
· Public warning and recall cost J&J $100 Million total (Burke)
o Could afford that because Despite Tylenol crisis:
§ After tax charge around $50 million, 27 cents/share in third quarter
§ Net earnings $2.52share year on sales of $5.76 billion compared to $2.51/share on sales of $5.40 billion in 1981 (increase of 6.7%)
Article 633
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