What We're Reading: Consumer Organization Files Lawsuit Against the FDA

What We’re Reading, April 29, 2016: While sales of Gilead's Harvoni drop, NY state attorney's decision could be good news for the company; and the FDA faces a lawsuit from a consumer advocacy group.

Hepatitis C is in the news again—in a sales call on Thursday, Gilead reported a slowdown in the sales of its blockbuster drugs Sovaldi and Harvoni. The company reported $4.3 billion in sales for Q1, which was $300 million off the analysts’ estimate and $600 million below the last quarter of 2015, according to STAT. Although the drug reached more patients in this quarter than the last, discounts and rebates significantly lowered the company’s revenue (the list price for Harvoni is $94,500 for a typical course of 12 weeks). But this could soon change if other states follow the lead of New York, where the office of the State Attorney General Eric Schneiderman has mandated 7 commercial health plans to change their coverage policies and provide the medications for nearly all the patients with the disease, not just those at the advanced stage.

Abbott Laboratories made a major announcement yesterday: the Illinois-based company will be buying St. Jude Medical Inc for $25 billion to expand on its heart device business, according to Reuters. According to Abbott’s CEO, Miles White, St. Jude’s devices to treat heart failure and abnormal heart rhythm complement their own cardiovascular products. The market did not react well to the news, however, and Abbott’s stocks fell by about 6%.

The nation’s regulatory authority has been sued by a consumer advocacy group. Public Citizen Foundation has filed a lawsuit against the FDA and the HHS, seeking greater transparency on the background of the advisory committee members than what is currently posted on the FDA website. Scientific and medical experts who serve on these committees review marketing applications submitted by drug developers, and their advice can have a significant impact on drug approvals by the FDA. The lawsuit claims that the “FDA redacts information from most of the advisory committee members’ CVs,” which the Foundation believes should appear in full.

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