In this week’s news, US FDA looks at drug shortages, UK firms turn to Ireland pre Brexit, new GDUFA II document published and more…
Better quality system recognition needed to avoid shortages says FDA
The US FDA says drug shortages are caused by regulatory challenges and market issues in a new report.
The regulator published the report last week in a bid to encourage industry to play a greater role in preventing drug shortages.
It said shortages have three root causes: Pharma not developing less profitable drugs; a lack of market recognition for firms with mature quality systems; and difficulties involved in recovering from production disruptions.
The agency also urged industry to do more. It said firms should make sure they understand the impact of drug shortages on patients to prevent practices that may contribute to shortages.
Also – following up on an idea mooted last month – the agency suggested a rating system to incentivise manufacturers to invest in quality management maturity for their facilities.
The FDA added that a greater focus on the sustainability of manufacturing by payers, purchasers, and group purchasing organisations would help head off potential problems.
CDER director calls for political help to ensure drug plants inspected
In related news Janet Woodcock, director of the Center for Drug Evaluation and Research, has asked US politicians to tighten up rules that allow some API and drug firms to bypass inspection rules.
Inside Health Policy reported that Woodcock urged Congress to address loopholes in FDA authority that let API and finished product firms ship to the US without having been visited by agency inspectors.
Read more here.
More UK firms seek to switch EU drug authorisations to Ireland ahead of Brexit
The HPRA has seen a surge in firms with UK marketing authorisations seeking to transfer them to Ireland.
The Irish regulator reported it has seen a four-fold increase in firms seeking to make the switch, attributing the increase to concerns about Brexit.
See the full report here.
US FDA seeks to clarify GDUFA II with revised guidance document
The US FDA has published revised guidance on its generic drug user fee program (GDUFA II) to clarify the fee structure and assessment process.
The regulator issued the document last week, explaining “Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
GDUFA II gives the FDA authority to collect user fees from generic drug companies seeking approval through to 2022. The Act eliminated the need for prior approval supplement fees and added program fees.
In addition, it made clear plants at which active pharmaceutical ingredient (APIs) and finished dosage forms (FDFs) are made will incur FDF fees.
Also in the news
Data falsification is still a major problem at API and drug manufacturing facilities in India and China according to a report by STAT.
Pharmsource looks at dynamics in the small molecule drug ingredient manufacturing sector.
Developments of note in the contract manufacturing sector.
Arranta Bio has formed a strategic partnership with Thermo Fisher Scientific. The focus will be the development of live biopharmaceutical products (LBPs) using bacterial fermentation. The CDMO also provides isolation, drying and encapsulation services.
Catalent and Cycle Pharmaceuticals have partnered to develop novel drug formulations of products intended for the treatment of patients suffering rare diseases.
Absorption Systems has been contracted by the US FDA to help streamline the agency’s approval and testing procedures for oral generics.