US shutdown disrupts operations at the FDA, EU SPC manufacturing waiver a step closer, EFPIA bemoans a no-deal Brexit and more…
Government shutdown hits US FDA hard and may delay drug approvals
The US Government shutdown and its impact on the FDA dominated the headlines again last week after agency Commissioner Scott Gottlieb said many of the agency’s key functions are “not getting done.”
The shutdown began in December when President Trump refused to sign the Government’s 2019 budget because it did not include funding for a border wall with Mexico. Until Trump signs, funding for federal agencies is suspended.
The deadlock is impacting the FDA according to Gottlieb, who tweeted:
It is not business as usual at FDA. Many key functions aren't getting done. But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions
— Scott Gottlieb, M.D. (@SGottliebFDA) January 13, 2019
A STAT report on January 14 suggested drug approvals could be jeopardised if the shutdown continues, citing candidates by Janssen, Sanofi and Novartis as examples of products that could face delays.
Elsewhere Bloomberg speculated the shutdown would impact the FDA’s ability to hire scientific staff. The news wire argued that funding instability would make it harder for the agency to compete with industry when it comes to attracting top talent.
And the negative impact the shutdown has on the FDA is likely to continue even after it is resolved. Analysis by Lachman Consultants suggests agency operations will be affected for at least 10-months after it receives funding.
EU proposed SPC manufacturing waiver wins more support
EU ambassadors have backed plans to let generics firms start making versions of innovative drugs before their supplementary protection certificates (SPC) expire as long as they are intended for export.
The Council of the EU announced the development last week, commenting that, “The EU has come a step closer to adopting new rules that will boost the export of generic medicines and biosimilar products to third countries.”
Under the proposal, generics firms could manufacture for export before the expiry of the protection period afforded to innovator drugs by an SPC.
At present generic firms have to wait until SPC expiry to start production which, according to the EU, gives non-EU based manufacturers an advantages over those in Europe.
The proposed waiver – which is due for further discussion after Romania assumes presidency of the EU – is a cause of concern for the branded pharmaceutical industry.
Last week EFPIA suggested the waiver is an erosion of EU intellectual property protection that may negatively impact Europe’s attractiveness as an investment destination for innovative pharma.
Abbott Laboratories wins US approval for smallest ever heart implant
US regulators have cleared a ‘pea sized’ implant designed to correct heart defects in premature babies.
The implant – called the Amplatzer Piccolo Occluder – was developed by Abbott Labs to address patent ductus arteriosus, a condition resulting from the failure of holes present in the hearts of developing foetuses to close.
According to Bloomberg the approval is significant because it is a further indication that the medical device sector is focused on the development of smaller, less invasive technologies.
No-deal Brexit a threat to patient safety and public health
EFPIA has raised concerns about the UK Parliament’s rejection of a proposed withdrawal deal with the EU.
The group said the prospect of the UK leaving the EU in a disorderly manner on 30 March 2019 without a deal is a “very real, tangible and immediate threat” to patient safety and public health in the UK and across Europe.
EFPIA Director General Nathalie Moll said “Now is the time for policy makers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit.
“In particular from disruption to the supply of medicines including from transport delays at the border and where the development, manufacture, packaging, safety testing and regulation of the medicine no longer benefits from mutual recognition.”
EFPIA also issued a list of contingency measures it believes the EU and industry need to take.
Also in the news
According to Nature the 59 drugs approved by the US FDA last year have ‘lacklustre’ commercial potential.
STAT covered a spat between Novartis and Dutch authorities regarding the former’s decision to increase the price of a cancer drug called lutetium octreotate.
The publication said the case has implications for both the orphan drug designation granted to niche products and in hospital manufacturing.
Germany has plans to foster the growth of its biotechnology sector according to Lifescienceleader.
Several major players in the outsourcing sector shared their thoughts on trends in contract analytical testing with Drug Development.
Industry guru Jim Miller told DCAT contract manufacturers face an uncertain 2019, citing shifting market dynamics and political upheaval on both sides of the Atlantic as key drivers.
GEN reported the pharmaceutical industry’s slow move towards continuous manufacturing is still ongoing.