In this week’s news, FDA plans to delist drugs for which it has inaccurate records, new cGMP Q&A published and more…
US FDA puts pharmas with outdated drug info on notice
Drug companies are being urged to check their products in the US after the FDA said it plans to delist medicines whose records are outdated.
The US regulator announced its plan last week, framing it as part of an effort to improve supply chain integrity. The agency said it will delist drugs whose records are outdated or inaccurate.
Under US drug laws, manufacturers are required to register products in a central database. The records must include a range of details, including the address of the facility at which the product is made.
Acting Commissioner Ned Sharpless said, “While most companies are compliant, we have observed that some drug listings contain obsolete or inaccurate information.
He added that “While there hasn’t been any public health consequence yet of these outdated listings, inaccurate information has the potential to compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health.”
Any delisted products may not be sold in the US until their records are updated.
The FDA’s plan raised concerns in the pharmaceutical industry.
Lachman Consultants blogged about the plan, urging drug companies to check all the information in their records – including details of any CDMOs involved in production – is correct.
US FDA issued new cGMP Q&A
In other news, the US FDA has issued a revised version of its cGMP Q&A document for pharmaceutical companies.
The document – which was published last Monday – focuses on laboratory controls used during regulated manufacturing processes. It is designed to help firms ensure their processes are compliant.
Several new questions are included in the revised version.
Question 15 touches on the types of materials that can be used to calibrate chromatographic systems – which are used to separate product from biopharmaceutical production streams.
Question 16 covers materials that manufacturers should use when assessing the suitability of a particular system to the production process they are using.
Finally, question 17 covers the thorny subject of “trial injections” of test samples during process development.
The Agency asked whether it is ever appropriate to carry them out when working with chromatography systems (spoiler alert – it isn’t.)
Also in the news
Fiercepharma reported that Teva plans more cuts to its manufacturing infrastructure.
RAPS looked at the burgeoning cancer biosimilars market in the US. According to an analyst quizzed by the publication, such products are likely to bring down the price of originator drugs 70% in the next five years.
The Medical Device Innovation Consortium (MDIC) is seeking comments on resources to support its Framework for Patient Input in Medical Device Clinical Trials. See here.
Researchers predict the FDA and EMA diverge on the drugs they approve. The study authors suggest that differing definitions of efficacy may start to see greater separation between the agencies in future.
CDMOs continue to benefit from biopharma efforts to shed internal manufacturing capacity according to Bioprocess Insider.
US CDMO Berkshire Sterile Manufacturing is to install a third isolator line at its facility in Berkshire County, Massachusetts. See press release.
Samsung Biologics has accelerated production at its facility in Songdo using new perfusion technology. According to the Korean firm the system allowed it to reduce production time by 30%. See press release.
Askbio has acquired Sypromics to expand is capacity for gene therapy production. See release.