Business-in-Brief
Addressing the opioid crisis, 3D printing drug guidelines, and execution drugs… What’s new for pharma in business?
Regulation
The EMA and European Commission have published two documents containing guidance for pharma companies to help them prepare for Brexit. The documents answer queries covering the rights of market authorization holders, pharmacovigilance systems, manufacturing sites, recalls, studies, and more.
The FDA has release a guidance document in the hopes of stemming the ongoing opioid crisis in the US. It outlines general principles for abuse deterrence and encourages the development of generics with abuse-deterrent formulations, citing studies into the main routes of abuse and what properties facilitate them.
On world AIDS day this year – December 1, 2017 – the FDA announced that earlier in the week, they had (tentatively) approved the 200th antiretroviral therapeutic in the US. In 2003 the President’s Emergency Plan for AIDS Relief (PEPFAR) was launched to address the global epidemic by stimulating the creation of HIV drugs. The FDA made a statement to celebrate PEPFAR for its role in achieving the milestone.
Manufacture
Following the hurricane that swept through Puerto Rico in September, the FDA says there are still shortages of approximately 90 medical products, including drugs, biologics, and medical devices, due to the disruption of manufacturing facilities based in the US territory. The issues are being addressed but it will take time until things are back to normal.
In the wake of recent US States attempting to sue pharma companies in recompense for the nation’s opioid crisis, one manufacturer has taken to fighting the problem by creating an addiction treatment. Indivior now has an FDA-approved experimental drug – Sublocade – which is a monthly injectable that, alongside counselling, aims to help treat drug addiction.
Controversy
AmerisourceBergen has pleaded guilty to allegations from the US Department of Justice that it distributed drugs from a facility unregistered with the FDA. AmerisourceBergen agreed to a payment of $625 million and a three-year compliance agreement. Combined with the company’s False Claims Act suit settlement in September, the company has had to pay out a total of $885 million to resolve civil suits over the last few months.
After Pfizer stated it would stop the distribution of its drugs for use in executions in 2015, the company offered to reimburse US states in exchange for the return of the relevant drugs. A few US states hadn’t been responsive to Pfizer’s offer, but now say they will not return the drugs and that they intend to use them in upcoming executions.
