In this week’s news, US FDA updates inspection plan for injectable drug plants, EFPIA raises concerns about Brexit ‘deal’, EMA stresses benefits of trial failure transparency, and more…
US FDA revamps injectable drug plant inspections
The US FDA has revised how it inspects sterile drug manufacturing facilities, introducing new assessment, recording and reporting procedures.
The programme – the New Inspection Protocol Project (NIPP) introduces electronic inspection and data collection protocols as well as questions related to ‘quality culture’ at the facility being assessed.
The changes will enable more consistent oversight and efficient analysis of findings says Commissioner Scott Gottlieb, who explained that the agency aims to cut the risk of supply interruptions caused by failed inspections.
“The new tool is being applied to our inspectional work related to sterile injectable drugs, which have been the subject of sterility problems and shortages in the past” he said.
The programme is also designed to support agency inspectors, Gottlieb added.
“Investigators who conduct aseptic processing drug inspections for sterile products have a lot on their plates. From climbing into a full-body sterile Tyvek suit with goggles to conduct a walk-through, to spending long hours observing aseptic techniques, to reviewing large volumes of data; these inspections take extensive precision, experience and dedication.
“The goal of the new protocols is to make that work more thorough and efficient. The protocols provide a more structured and informative tool for completing inspections.”
EFPIA worried about UK Government’s Brexit plan
EFPIA says the UK Government’s proposed EU withdrawal deal fails to address issues that will impact public health and the drug industry.
According to EFPIA – which represents drug makers in the UK and other EU member states – the deal does not cover how the production and supply of medicines will be regulated after Brexit.
Director General Nathalie Moll said. “It is extremely concerning that the political declaration fails to specifically address the health issues important to patients, their safety and the wider public health.
“While we welcome the commitment to create a ‘free trade area combining deep regulatory and customs cooperation’ referred to in the political declaration, its failure to contain an explicit reference to the importance of securing long-term, extensive cooperation around the regulation of medicines is not in the best interest of patients.”
The Government plan that was published last week prompted several ministers who disagreed to resign. Whether the agreement will be approved by Parliament remains to be seen.
Drug firms need to fess up about trial failures to speed up R&D says EMA
EMA experts have called on pharmaceutical companies to share details of failed clinical trials, arguing that greater transparency will foster a more effective R&D culture in the industry.
Writing in Nature, Enrica Alteri, EMA head of the R&D support, and colleague Lorenzo Guizzaro suggested drug firms need to share more details of failed clinical trials to allow for the development of better protocols.
“Practices to enable more-thorough, earlier analyses of failed developments should be adapted to treatments for other challenging diseases, and should be part of regulators’ responsibilities. This will ensure that clinical research evaluates treatments faster and with more certainty” they wrote.
The authors cited a project in which companies shared information on failed efforts to develop treatments for Alzheimer’s disease as an example of the benefits disclosure can have for patients and the industry.
“We believe that what the companies learnt (indirectly) from one another will lead to faster, more-informative clinical trials. In our view, if this information had been put together sooner, decision-making after early-stage trials could have been improved.”
They explained that rather than asking the companies to provide data, the EMA had requested that participating companies “walk us through their logic and the evidence that led, in most cases, to disappointing results in large clinical trials.”
Also in the news
European science organisations have asked for larger scientific research budgets to boost European competitiveness and cooperation. Read more at Science Business.
Silicon Valley will not drive innovation in the pharmaceutical sector according to tech billionaire Sean Parker. Speaking at an event hosted by the Washington Post, Parker said people coming into biology from the tech world underestimate the challenge involved in drug development.
The US FDA has begun updating its labelling requirements for generic chemotherapies. Read more at RAPS.
Novartis may price its AVXS-101 a gene therapy to treat spinal muscular atrophy (SMA) at $4m for a single treatment. Read more at Forbes.