Regulation FDA Commissioner Scott Gottlieb has announced FDA plans to close a legal loophole that allows companies to avoid pediatric study requirements. The loophole is an unintended consequence of two US bills: the Pediatric Research Equity Act (PREA) and the Orphan Drug Act (ODA). PREA requires companies to study pediatric populations after approval, but if an approved drug for an adult population receives designation under the Orphan Drug Act to treat a subset of children, then it becomes statutorily exempt from PREA requirements. “It’s a loophole that is in direct opposition to what Congress intended,” says Gottlieb. https://blogs.fda.gov/fdavoice/index.php/2017/09/fda-is-advancing-the-goals-of-the-orphan-drug-act/ The UK life sciences industry hopes to see the UK prioritize close ties to the EMA post-Brexit. The report, published by the UK Life Sciences Industrial Strategy Board, argues, “the UK market is too small even with the fastest and most innovative regulatory system in the world, to stand alone from a larger decision-making bloc,” despite the MHRA’s record of driving innovation in the EMA. “Given the UK market size at around three percent of global pharmaceutical sales, a wholly free-standing system would likely be high cost – both in terms of efficiency and attractiveness to companies who typically apply to the largest markets first,” wrote the authors. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/640696/life-sciences-industrial-strategy.pdf
Manufacturing Eli Lilly is set to cut 3500 jobs – 8 percent of its global staff – and close several facilities in an attempt to save $500 million. The company expects the majority of the job loses to come from their voluntary early retirement program in the US. A research and development office in New Jersey, US, and the Lilly China Research and Development Center in Shanghai are also set to close. Lilly expects the closures, severance expenses, and the retirement program to cost $1.2 billion pre-tax. https://investor.lilly.com/releaseDetail.cfm?ReleaseID=1039538
Controversies Allergan has transferred all patents for its billion dollar dry eye drug, Restasis, to the Saint Regis Mohawk Tribe. The New York based Native American Tribe agreed to grant exclusive licenses to Allergan in return for a $13.75 million payment, plus $15 million annual royalties. The controversial arrangement, if successful, would allow Allergan to avoid an ongoing challenge against the validity of its Restasis patents, because the tribe is recognized as a sovereign tribal government under US law and is immune from IPR challenges. https://www.allergan.com/news/news/thomson-reuters/allergan-and-saint-regis-mohawk-tribe-announce-agr Pharmaceutical companies in Australia gave AU$12 million to doctors, nurses and pharmacists between November 2016 and April 2017, according to a report. Health economists Philip Clarke and Barbara de Graff conducted an analysis for a newspaper and found, “the payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.” https://www.theguardian.com/australia-news/2017/sep/12/pharmaceutical-companies-gave-12m-to-doctors-nurses-and-pharmacists
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