In this week’s news, US FDA tweaks manufacturing and supply chain rules, India urges desk inspections, and more…
US FDA issues more manufacturing advice for drug firms during pandemic
The US FDA has explained how CDMOs and drug firms can implement manufacturing and site changes during the pandemic.
The regulator issued the guidance last week, explaining the aim is to help manufacturers to change processes or switch facilities.
There are different processes for plants making drugs to treat Covid-19 patients from those not directly involved.
FDA Inspection halt
There is also guidance on how drug firms can include facilities that cannot be inspection due to travel restrictions.
The FDA wrote it “will continue the quality assessment of all applications per normal assessment operations for all disciplines, where all manufacturing facilities will be evaluated using risk-based approach as per existing guidelines.
“During this interim period, we are utilizing additional tools to determine the need for an on-site inspection to support the application assessment such as reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records “in advance of or in lieu of” on-site drug inspections.
It added that “If the final determination is an on-site inspection is necessary, an application may receive a Complete Response.”
India urges US FDA to conduct “virtual” inspections
In related news, Indian drug and API firms have called for US FDA “virtual inspections” according to various reports.
The Indian Pharmaceutical Alliance (IPA) asked to FDA carry out virtual inspections to “ensure the continuous supply of much-needed drugs in the United States,” according to a report by FiercePharma.
The article suggests the IPA wants virtual inspections for new facilities, those being lined up to make novel products or those that have completed a corrective action plan following a previous failure.
Inside Health Policy said IPA secretary general, Sudarshan Jain is concerned the indefinite postponement of FDA foreign inspections could lead to disruptions in America’s drug supply.
US FDA temporarily relaxes supply chain security rules
In other news the US regulator has relaxed certain provisions of the Drug Supply Chain Security Act (DSCSA) to prevent shortages.
In a document last week the agency outlined exemptions from some DSCSA product tracing and identification requirements. It also tweaked certain trading partner authorisation rules, which it said should ease the flow of drugs.
The agency also pointed out that, despite the exemptions, supply chain security is still important.
It wrote, “Some people and companies are trying to profit from the COVID-19 pandemic by selling unproven and illegally marketed products with false claims, such as claims that the products are effective in the diagnosis, treatment, or prevention of COVID-19.
“Some of these products may result in serious adverse health consequences. Wherever possible, trading partners should engage in transactions of product with trusted sources.”
EMA tells drug industry how to speed R&D during Covid-19 pandemic
The EMA has issued more advice to help pharmaceutical firms speed-up development and approval of medicinal products for coronavirus disease.
The agency set out a programme of R&D support and provided detailed procedures for accelerated review and approval. It also clarified rule on compassionate use.
Also in the news
Generic and biosimilar drug industry group the Association of Accessible Medicines has issued what it calls a “blueprint for supply chain security” to ensure the availability of drugs in the US.
According to Inside Health Policy the AAM wants the US department of Health and Human Services (HHS) drug firms to incentivize both individual companies and the entire industry to ramp up domestic manufacturing.
Former FDA chief Scott Gottlieb says the US will have an “economic advantage” if it is first to develop a SAR-Cov-2 vaccine. Read the Wall Street Journal article.
The WSJ also reports that “miscalculation” at every level of Government left the US unequipped to fight Covid-19.
Some developments of note in the contracting sector:
Trio Pharmaceutical will test Ajinomoto Bio-Pharma Services’ antibody drug-conjugate technology in combination with drugs it is developing under a deal announced last week. Trio will apply the technology to some of its dual action antibody drugs. See press release.
Johnson & Johnson has hired Catalent to “accelerate availability of manufacturing capacity” and prepare for large-scale commercial production at its facility in Bloomington, Indiana.
Moderna has chosen Lonza as manufacturing partner fort its RNA-based SAR-CoV-2 vaccine candidate. See press release.
Fareva is buying two manufacturing facilities from Pierre Fabre, which says contract manufacturing is not a priority. See Bioprocess Insider story.
Inovio has hired Richter-Helm BioLogics GmbH & Co. KG to support large-scale manufacturing of the investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing for COVID-19. See press release.