Morning Briefing
Summaries of health policy coverage from major news organizations
Gilead Presses For Exclusivity On HIV Drug After Judge's Ruling That FDA Policy Is 'Capricious'
Stat: Gilead Asks FDA To Expand Exclusivity For A Key HIV Drug
In the latest development in a heated battle between Gilead Sciences and the US Food and Drug Administration, the company petitioned the agency this month to retroactively grant five years of exclusive marketing for an HIV medicine. And the drug maker argues that it otherwise faces lost sales and added expense from fending off a pending generic threat to its Stribild medication. The move follows a complicated legal battle in which Gilead challenged an FDA policy toward so-called fixed-dose combination drugs, which consist of two or more chemical entities. At stake are untold amounts of revenue as Gilead and other drug makers have battled the agency over its policy, which a federal judge recently ruled is “arbitrary and capricious.” (Silverman, 10/20)
Politico Pro: Groups Press FDA For Biosimilar Policy, Resources
FDA must move faster to develop policies for cheaper versions of biologic medicines, and Congress should provide more resources to enable faster agency review, a broad array of health care groups told FDA. Gaps in FDA policy on biosimilars are creating challenging situations for states, providers and health insurers who must deal with already approved biosimilars, the agency was told at a Thursday meeting on a recently announced user fee agreement. The groups said the agency should finalize its guidance on key biosimilar policies — such as how to name and label treatments, and when biosimilars can be considered "interchangeable" with their brand counterparts — ahead of deadlines specified in that agreement. (Karlin-Smith, 10/20)
And in other pharmaceutical news —
The Wall Street Journal: Alkermes Shares Surge On Favorable Data For Depression Drug
Alkermes PLC said its depression drug helped patients not responding to standard treatments, news that added more than $3 billion to the company’s market value in after-hours trading. The company said that in a late-stage trial, its ALKS 5461 treatment significantly improved depression scores in patients who had an inadequate response to standard therapies. The most commonly reported adverse events associated with the treatment were nausea, dizziness and fatigue. (Beckerman, 10/20)
