List date(s) this work was published or aired.
Feb. 10, 2011
Provide a brief synopsis of the story or stories, including any significant findings.
A hard-hitting, front-page story about KV Pharmaceutical’s pricing of its pre-natal drug Makena, one of the first and most comprehensive stories that kicked off a national controversy about the company’s pricing and FDA approval of a drug for women with high-risk pregnancies.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The initial Makena story relied mainly on human sources, but also incorporated Securities and Exchange Commission documents. Follow-ups relied heavily on FDA advisory committee minutes, Form 990s, medical studies, lawsuits, FDA regulations, and law journal articles, and phsycian trade group correspondence.
Explain types of human sources used.
The initial Makena story as well as its follow-ups involved interviews with company officials including KV’s competitors, state health and social service officials, compounding pharmacy executives, FDA current and former administrators, physicians, Senate staff members, law professors, foundation officials, and Wall Street analysts.
Results:
The controversy over KV’s pricing of Makena sparked an uproar from the medical community, which caused the Food and Drug Administration to withdraw KV’s market monopoly, allowing smaller compounding pharmacies to produce low-cost generic equivalents. That decision drove down the price of the drug, making it available to more women with high-risk pregnancies.
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.
No corrections, clarifications or challenges. Thirteen follow-up stories probed the FDA’s approval of the drug, despite an advisory committee’s recommendations of further scientific testing; the medical community’s harsh criticism of KV’s price hike; and the financial ties between KV and the March of Dimes Foundation.
Advice to other journalists planning a similar story or project.
If you keep your eyes open, routine beat coverage can produce strong investigative stories. I began writing about Makena in January 2011 as part of my ongoing coverage of KV Pharmaceutical’s series of troubles in recent years, including its criminal convictions for KV’s former chairman and one of its subsidiaries. The trick here was listening closely to a mentor, who anticipated that KV officials might use their new, FDA-sanctioned monopoly on the drug to radically jack up its price — and hopefully salvage their company. With that tip, I looked for and found evidence of the planned price hike and documented the repercussions on patients and state Medicaid programs — then began to delve into the issues further through follow-up stories, closely examining the FDA’s approval of the drug and KV’s financial ties with the March of Dimes.