Closing The Books On Purdue – And US FDA’s Policies To Control Opioids

A massive settlement of opioid litigation is intended to end the era of opioid marketing defined by OxyContin. It also like closes the books on efforts to rely on the US FDA to control the prescription abuse crisis.

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What will the history books say about the US FDA's risk management plans for opioids?

There is very little reference to the US Food & Drug Administration in the settlement documents released by the Department of Justice in its resolution of opioid litigation with Purdue Pharma L.P.

There is just one reference in the context of one of the criminal counts against Purdue: “Purdue knowingly and intentionally conspired and agreed with others to aid and abet [Health Care Providers’] dispensing, without a legitimate medical purpose and outside the usual course of professional practice (and thus without a valid prescription), prescription drugs held for sale after shipment in interstate commerce, thereby rendering the dispensed drugs misbranded in violation of the Federal Food, Drug, and Cosmetic Act,” the

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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EU Shaping Biotech Act To Unleash SME Potential

 

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
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Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.