Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.

The pharmaceutical industry and the UK government are beginning a series of discussions on the shape of the future voluntary drug pricing and access scheme (VPAS), ahead of the formal negotiations that are scheduled to start in April.

Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.

US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.

The ABPI, which represents the R&D-based pharmaceutical industry in the UK, says the proposed increase in the statutory scheme rebate sends "the worst possible signal" to global investors and boardrooms.

Third Circuit is first of three federal appeals courts to issue a decision in multiple lawsuits over drug companies’ 340B contract pharmacy restrictions, which have led to conflicting lower court rulings on whether such restrictions are unlawful.

US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.

US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.

Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.

Industry leaders are concerned about the outlook for small molecule drugs in particular, but execs at the J.P. Morgan Healthcare Conference were also optimistic there could be chances to shape the implementation of certain policies.

However, similar claim in materials directed at health care providers need not be discontinued, National Advertising Division says in challenge brought by Lilly; NAD decisions in Rx promotion disputes are rare, but voluntary resolution process could become more appealing to pharma firms.

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.