In this week’s news, the FDA is pressured to address Covid-19 inspection backlogs, The WHO sets out manufacturing safety measures around radiopharmaceuticals and CDMOs are urged to start planning for post-COVID demands.

GAO says US FDA needs to address Covid-19 inspection backlog and overseas inspection

The US Government Accountability Office has raised concerns about the FDA’s facility inspection backlog.

The GAO made the comments in a report published late last week, writing that the agency need to put together a plan to deal with the backlog and address longstanding issues related to overseas inspections.

“The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020.

“GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global pharmaceutical supply chain.”

WHO and IAEA advise on radiopharmaceuticals production

The WHO has set out the manufacturing safety measures CDMOs and drug firms making radiopharmaceutical should use.

The WHO – in collaboration with the International Atomic Energy Agency (IAEA) – issued draft GMP guidelines for investigational radiopharmaceuticals this week, citing the growing number of such products entering development.

The organisation wrote “Radiopharmaceuticals are rapidly re-emerging as clinically valuable tools used in the diagnosis and treatment of various types of disease,” adding “This rapid expansion is accompanied by a set of challenges due to the complexity and unique nature of these agents.”

The WHO cited manufacturing control as one of the major challenges, pointing out that measures used during production for early studies need to be augmented for later Phase trials.

The guidance provides a recommended quality management system and details which personnel should be involved with which aspects of production and development as well as the clinical trial process.

According to Grand View Research, the market for radiopharmaceuticals – which was valued at $6.1 billion in 2019 – will be worth $12.6 billion by 2027.

Also in the news

Consulting group BCG says CDMOs seeing a surge in demand during the pandemic need to plan for a post-Covid world.

Reuters reported that Pfizer plans to manufacture its coronavirus vaccine in India if assured of faster regulatory clearance and freedom on pricing and exports.

Fierce Pharma looked at the top 10 most valuable pharmaceuticals that will lose patent protection in the US this year.

The US FDA will begin supporting updated versions of clinical data interchange standards in the areas of reproductive toxicology and study data tabulation, effective 15 March. Read more at RAPS.

UK packaging technology firm Softbox has spoken about collaboration with Pfizer on the development of an ultra-low temperature shipment solution for the Covid-19 vaccine.

SCHOTT says its pharmaceutical packaging business unit has delivered enough vials to provide more than 1 billion doses of Covid-19 vaccines. See press release.

CDMO tends

Some developments of note in the contracting sector:

API supplier Dr Reddy’s has been issued with a Form 483 with three observations after inspecting its manufacturing facility in Middleburg, New York. See full Economic Times report.

Fujifilm Diosynth Biotechnologies plans to double cell culture capacity at its plant in Denmark.

Moderna has hired Baxter to provide fill and finish services for its Covid-19 vaccine. Read more at Reuters.

Altasciences has started expanding its facility in Philadelphia. See press release.

ANI Pharmaceuticals has signed a definitive agreement to acquire Novitium Pharma.