In this week’s news, US FDA halts domestic inspections, regulators advise on Covid-19 clinical trials and more…
US FDA stops inspecting domestic drug plants citing Covid-19 pandemic
The US Food and Drug Administration (FDA) has postponed all domestic routine surveillance facility inspections.
The US regulator said the decision was prompted by concerns about “the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors.”
As recently as last Monday the FDA was still visiting US drug manufacturing sites – including one operated by an unnamed CDMO according RAPS.
The agency stressed inspections were just one part of its oversight of drug safety, explaining that it would be evaluating records in lieu of conducting an onsite visits on an interim basis.
It wrote “inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products, however inspections are not what cause quality to happen.”
The agency added that safety and quality need to be “owned by the industry” and firms have the primary responsibility to reliably produce quality products, explaining that adherence to GMP is the best approach.
EMA and FDA offer guidelines on Covid-19 clinical trials
Regulators on both side of the Atlantic have issued guidance on how to carry out clinical trials during the Covid-19 pandemic.
In a statement last Wednesday the US FDA said the pandemic “may impact the conduct of clinical trials,” citing challenges arising from site closures, travel restrictions and supply chain interruptions as likely issues.
It acknowledged that, under such circumstances, protocol modifications may be needed and added that deviations may be unavoidable.
To try and minimize disruption the FDA suggested firms evaluate alternative assessment methods, including phone contacts or virtual visits. It also advised sponsors to implement extra safety monitoring for people who may no longer have access to investigational product or site.
The EMA issued similar guidance.
It said, “The situation is evolving, and pragmatic actions may be required to deal with the challenges of conducting research, and in ensuring the rights, safety and wellbeing of participants.”
Like the US FDA, the EMA suggested phone or video “visits.” It also said some sponsors may need to close trial sites, or postpone the activation of those that have not been active, and slow down recruitment.
The EMA also said it would likely release more guidance as the pandemic develops.
Also in the news
The US FDA is to implement all Covid-19 related guidance immediately, without public comment according to RAPS.
Fiercepharma reports that Pfizer says it will share its drug development knowhow, tools and manufacturing capabilities with companies working on promising anti-COVID-19 candidates.
US publication The National Interest says the Covid-19 pandemic is likely to disrupt drug supply chains citing ex-FDA chief Scott Gottlieb.
US President Donald Trump says his assertion the antimalarial hydroxychloroquine can treat Covid-19 is based on a feeling according to STAT.
In related news Reuters reported the surge in demand for hydroxychloroquine prompted by Trump’s feeling is likely to result in shortages.
A CDMO industry group says members “report no material disruptions to their operations” as a result of the Covid-19 pandemic. See press release.
Oxford Biomedica will make vectors for Juno Therapeutics’ CAR-T and TCR-T programmes according to Bioprocess Insider.
Emergent Biosciences has been hired to manufacture a candidate SARS-cov2 vaccine by Novavax. The vaccine is poised to enter Phase I trials.
The US FDA has approved use of a Covid-19 detection kit made by Thermo Fisher Scientific.