In this week’s news…
US FDA unveils price lowering re-importation plan
The US FDA has announced a plan to help reduce drug prices that will involve the re-importation of medicines made in the US that have be supplied to other countries.
The regulator shared details last week, explaining the plan allows specific agency-authorized programs to import certain drugs from Canada.
The caveat is that the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the US consumer.
The plan – which was prompted by an executive order from the White House – is part of an effort to “promote choice and competition,” according to FDA commissioner Stephen Hahn.
Reaction to the proposal was mixed, with some – like Politico’s head of research Alex Gaffney – predicting it would prompt a flurry of lawsuits.
UK issues guide on supplying meds to Northern Ireland after Brexit transition
The UK MHRA has issued guidelines on supplying medicines from Great Britain to Northern Ireland after the end of the Brexit transition period.
According to the EU Withdrawal Agreement agreed last year, “Goods placed on the market in the European Union or the United Kingdom before the end of the transition period may continue to circulate between these two markets from 1 January 2021.”
The MHRA guideline defines ‘placed on the market’ as products that have been “certified by a qualified person and released for sale or supply before 11pm on 31 December 2020.”
Manufacturers must certify batches were placed on the market in time, in writing. They are also responsible for confirming an authorised person receives the products in Northern Ireland.
UK and EU face drug supply disruption post Brexit say trade groups
UK and European drug trade groups say action is needed to prevent disruption of drug supplies after the Brexit transition period ends.
The Association of the British Pharmaceutical Industry (ABPI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) issued a joint statement urging the UK and the European Parliament to form a mutual recognition agreement.
ABPI CEO Richard Torbett said “It is absolutely clear that it’s in nobody’s interest – and certainly not patients – to face the future with uncertainty around how medicines will be regulated, tested and moved throughout Europe and the UK.
He added, “The UK Government and European Commission have an opportunity to end this uncertainty and strengthen healthcare systems with an agreement on medicines whilst negotiations continue.”
Also in the news
The US National Institute for Innovation in Manufacturing Biopharmaceutical (NIMBL) published its annual report. The organisation noted a 20% increase in biopharmaceutical R&D investment in 2019.
The Pink sheet reported the US FDA is racing to complete its list of Essential Medicines for domestic manufacture by the October 4th deadline set by the White House.
Some developments of note in the contracting space:
Thomas H. Lee Partners and Frazier Healthcare Partners have acquired Adare Pharmaceuticals. The investors said they plan to rename the CDMO Adare Pharma Solutions.
Catalent has paid $14m for a manufacturing facility in Bloomington, Indiana. The CDMO said it plans to use the facility as a centre of excellence for early-phase clinical biologics formulation and fill/finish services.
Thermo Fisher Scientific has joined the list of contractors signed up to make Humanigen’s Phase III Covid-19 candidate lenzilumab.
BioDuro and Sundia have partnered to set up contract research, development and manufacturing organization with operations in China and the US.
AstraZeneca has signed a long-term commercial manufacturing deal with Samsung Biologics.