Tag Archives: U.S. Food and Drug Administration

Pfizer Settles Whistleblower Case for $2.3 Billion

Image by Getty Images via Daylife Pfizer, on Wednesday, agreed to pay $2.3 billion to end a US Department of Justice investigation citing the company for illegal off-label marketing tactics related to a number of products. It represents the largest single settlement of its type for a pharmaceutical company, topping Lilly’s $1.4 billion Zyprexa settlement […]
Posted in Legal | Also tagged , , , , , | 3 Comments

Feds Chase Down Faulty Skincare Promos

FDA’s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson & Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims. J&J received a violation letter in response to a journal ad for […]
Posted in FDA, Marketing | Also tagged , , , | 2 Comments

FDA Readies More Warning Letters, Fast Enforcement Action

Image by Getty Images via Daylife FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too […]
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Adverse Event Reports Go Digital Only

Image via Wikipedia FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions. “This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information […]
Posted in Regulatory, Safety | Also tagged , , , , | 1 Comment

Lilly Osteoporosis Drug Canned in Phase III Trials

Image by go elsewhere… via Flickr Lilly, on Wednesday, announced that it would not seek regulatory approval for its osteoporosis treatment arzoxifene, because the drug failed to meet certain end points in Phase III clinical trials. The good news is that the drug was successful in meeting the primary end point of the trial, dubbed […]
Posted in Strategy | Also tagged , , , , , | 1 Comment
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