In this week’s news, US should up API capacity, EMA to publish doctor comms, UK to rejig medicine laws and more…

US should up API capacity to mitigate risks, says ex-FDA chief

The US needs to make more drug raw materials and APIs says ex-FDA chief Scott Gottlieb to mitigate the impact of disruption to global supply networks.

Gottlieb called for the expansion in a presentation to the Senate Committee on Homeland Security and Governmental Affairs on Protecting the US from Global Pandemics.

He raised concerns about US reliance on APIs made in China, warning the outbreak of coronavirus Covid-19 that began in Wuhan may impact supplies.

Gottlieb said, “When it comes to starting material for the manufacture of pharmaceutical ingredients, a lot of this production is centred in China’s Hubei Provence, the epicentre of coronavirus. Most drug makers have a one to three-months of inventory of drug ingredients on hand. But these supplies are already being drawn down.


“There are steps that we can take – both in the short term as well as the long run – to expand our supply chain for making these raw and intermediate components of drug production and mitigate risks to our supply chain,” he added.

Gottlieb suggested developing idle manufacturing capacity that could be brought online in the event of an emergency.

He also called for the FDA to be given more import sampling resources, arguing that disruption to the agency’s inspection activities in China resulting from the Covid-19 outbreak is likely to be long lasting.

“Congress can support efforts by FDA to increase import sampling and testing of regulated goods coming from China, since the agency will be hard pressed to make up for the lost inspectional activity, even after the current crisis has subsided. This will require additional resources for FDA’s inspectional program.”

Full statement available here.

US plans guidelines on gene editing and CAR-T

The FDA plans to publish draft guidelines on genome editing and CAR-T therapies this year.

The US regulator announced its intention in a guidance agenda last week.

The new documents will set out the FDA’s expectations for firms developing Chimeric Antigen Receptor (CAR) T-cell therapies, considerations for those making gene therapies, including those for neurodegenerative diseases.

The agenda comes a month after the FDA finalised guidance documents on gene therapies as RAPS pointed out.

EMA to publish communications drug firms send to doctors

The EMA will publish all communications drug firms send to healthcare professionals, including those related to medicines.

The European regulator announced its intention last week, explaining direct healthcare professional communications (DHPC) are vital to ensuring that drugs are used safely.

“DHPCs are important communications that are sent directly to healthcare professionals by marketing authorisation holders or a competent authority to inform them of new safety information about a medicine.”

UK plans to rejig drug regulations after Brexit transition period ends

The UK has introduced a bill to update its regulatory framework for medicines, clinical trials and medical devices,

Prime Minister Alexander Boris de Pfeffel Johnson withdrew the UK from the EU on January 31, triggering an 11-month transition period during which the UK will continue to follow UK law.

According to RAPS once the period ends “the UK will no longer be able to update its regulatory schemes for healthcare products and clinical trials through secondary legislation under section 2(2) of the European Communities Act (ECA) or via section 11 of the Consumer Protection Act (CPA) for certain aspects of medical device regulation.”

The new law – which is scheduled for a second reading on 2 March – delegates powers to update existing regulatory frameworks for drugs, devices and trials after from December 31.

Also in the news

The US FDA has published its annual report on drug quality.

CDMO trends

Some developments of note in the contract services sector:

PCI Pharma Services has acquired Bellwyck Pharma Services, a provider of packaging and labelling for the trial and commercial drug markets.

Zumutor Biologics has hired Catalent to make ZM008, a monoclonal antibody-based product for the treatment of solid tumors.

Samsung Biologics is exploring and planning on further investment options both at home in Songdo and globally according to BioSpectrumAsia.