In this week’s news, US FDA shares industry PDUFA VII desires, DSCSA provisions delayed over readiness concerns and more…

Industry wants PDUFA VII to be based on science and patient centricity

The drug industry wants PDUFA VII to focus on science, patient-centric reviews and modernizing regulatory evidence generation according to the US FDA.

The aims were outlined in notes released by the agency from the kick off discussion of the Prescription Drug User Fee Act (PDUFA) VII in July.

The FDA wrote “Industry’s proposals revolved around issues such as: strengthening scientific dialogue, enhancing patient-centric drug review, supporting the next wave of advanced biologic therapies, modernizing regulatory evidence generation, advancing digital and IT technologies, enhancing innovation in quality and manufacturing, and optimizing FDA infrastructure, staffing, and resources.”

For its part the FDA said the new PDUFA legislation should emphasise digital health and informatics, postmarket, CBER-specific enhancements, pre-market, regulatory decision tools and finance.

Also, the agency said that industry representatives “noted the possibility of lessons learned from the COVID-19 pandemic translating into improved processes for both parties.”

The meeting notes were published shortly before the FDA held its second discussion on September 22. Since then various subgroups have met to thrash out specifics. No further information from these meetings has been published.

FDA delays enforcement of some DSCSA rules for wholesalers

Enforcement of Drug Supply Chain Security Act (DSCSA) rules requiring wholesalers to verify saleable returned drugs they intend to distribute will be delayed according to the FDA.

The regulator announced its decision in the Federal Register last week.

It said “does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(c)(4)(D) of the [Federal Food, Drug, and Cosmetic Act] FD&C Act.”

Readiness concerns

Originally enforcement of the above requirement was due to begin in September 2019. The FDA said the delay was prompted by comments from wholesale distributors and others, “Expressing concern with industry-wide readiness.”

It wrote “comments received point out continuing challenges posed by the large volume of saleable returned product, explaining that wholesale distributors still need more time to test verification systems using real-time volumes of saleable returned product with all trading partners involved, as opposed to using small-scale pilot test projects.

“Additionally, wholesale distributors point to significant delays in testing these verification systems due to the competing priority of responding to the Coronavirus Disease 2019 (COVID-19) pandemic, namely the reassignment of logistics and supply chain experts from DSCSA matters to COVID-19 pandemic response.”

Also in the news

The AP reported growing concerns about the lack of coronavirus vaccine storage capacity. According to the report nearly 3 billion people live where temperature-controlled storage is insufficient for an immunization campaign to bring COVID-19 under control.

The New York Times said supplies of REGN-COV2, Regeneron’s developmental Covid-19 treatment, will be limited despite efforts to increase capacity.

Kodak still plans to make drug ingredients in the US despite questions about loan agreements with the US Government. See full Wall Street Journal story.

Also according to the WSJ, Pfizer is working on a distribution programme for its SARS-CoV-2 vaccine candidate.

CDMO tends

Some developments of note in the contracting sector:

Brainstorm Cell Therapeutics has hired Catalent to make NurOwn, its candidate autologous cell therapy for motor neuron disease.

In other cell therapy news, Catalent is buying Bone Therapeutics’ manufacturing unit – Skeletal Cell Therapy Support SA. The deal will see the CDMO make trial supplies of the candidate bone disease cell therapy, ALLOB.

Delpharm has announced its intention to buy a GSK facility in Poznan, Poland in an agreement that will also see it hire the 700 staff employed at the site. See more at Contract Pharma.

Lonza has restructured its business operations. The Swiss CDMO said the move reflects its focus on biotech and pharma.

The firm also announced plans to increase manufacturing capacity at its capsules business, Capsugel.

Bioeleven has hired Samsung Biologics to make BN-101A, an immunotherapy being developed to treat cancer. The CDMO will provide cell line and process development services as well as non-clinical and clinical material manufacturing.

Heidelberg Pharma has contracted Probiogen to provide cell line development and manufacturing services for its portfolio of antibody targeted amanitin conjugate (ATAC) molecules.