Provide names of other journalists involved.
Katherine Eban
List date(s) this work was published or aired.
23-May-11
Provide a brief synopsis of the story or stories, including any significant findings.
The article reveals the troubled pathway to the largest launch in generic-drug history– that of Lipitor in the U.S. market. It documents how the process unraveled, and explores serious questions about who will make the cheaper form of Lipitor, whether the price will really drop, and most disturbing of all, whether patients will be able to trust that the medication is safe.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
This article relied on extensive court records to reconstruct the corporate litigation over the drug launch, FDA inspection, investigation and warning reports into the problems at Ranbaxy and also benefited from over six FOI requests to the FDA, which detailed the government’s probe of Ranbaxy and its discovery of problems there.
Explain types of human sources used.
Pharmaceutical executives, consultants and employees, and legal and pharmaceutical experts in patent law.
Results:
Fortune has learned that the details in the story actually affected Daiichi Sankyo’s negotiations with the government over a settlement and may have impacted the final settlement, which is expected to be $500 million.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
There has been no challenge to the story’s accuracy and no correction
Advice to other journalists planning a similar story or project.
The difficulty will be that the FDA’s approval process of generic drug equivalents is a black box. The Agency releases remarkably little information, even to the applicants, about the content or pace of its review and approval process. However, generally analysts and company lawyers may be in the best position to know what signal, however small, the Agency has been sending.