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Medicare Wastage Rebate Exceptions For Small Volume Products, Cell/Gene Therapy Urged

Packaging for such products reflects ‘unique circumstances’ that should exempt them from the rebates on discarded drugs otherwise required by the policy, stakeholders tell CMS at a ‘town hall’ forum.

Reimbursement Pricing Debate Policy

EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency

A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.

Europe Clinical Trials Compliance

US FDA Punts To Congress On CBD: Rx Topics Remain Outside Political Spotlight

FDA is formally asking Congress to weigh in on the best approach to regulate CBD in consumer products. That provides another target for legislative attention that may mean that FDA’s core drug regulatory activities stay comfortably out of the spotlight.

Cannabidiol CBD FDA Guidance Documents

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Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals Review Pathway Drug Review


Global Pharma Guidance Tracker – December 2022

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International

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Latest From Regulation

EU Falsified Medicines Directive ‘Not Working’ In Northern Ireland

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.”

Europe United Kingdom

US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections

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.

Manufacturing Regulation

US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals

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.

Review Pathway Post Market Regulation & Studies

Next UK Drug Pricing Scheme Needs ‘Single-Digit Fixed Rebates’

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.

Europe United Kingdom

Pharmacies Likely To Cease Prescribing COVID-19 Therapeutics With End Of Public Health Emergency

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.

Coronavirus COVID-19 Vaccines

The IRA And US FDA: How Will Agency View Any Drug Development Changes?

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.

Research & Development Legislation

Latest From Policy

UK Industry Urges Government To Drop Statutory Pricing Scheme Rate Hike

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.

Europe United Kingdom

Pharma Gets 340B Appeals Court Victory But More Decisions Are Pending; Will Congress Step In?

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.

Pricing Debate Policy

Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?

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.

Pricing Debate Review Pathway

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Latest From Research & Development

The IRA And US FDA: How Will Agency View Any Drug Development Changes?

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.

Research & Development Legislation

US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests

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.

Advisory Committees Coronavirus COVID-19

Requests For EMA PRIME Designation Fall But Improvements Are On The Way

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.

Review Pathway Innovation

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The Immortal Humira? In Huge Test For US Biosimilar Policy, Brand May Still Have Edge

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.

Biosimilars Biologics

In Medicare Drug Price Negotiations, Industry Sees Drawbacks And Silver Linings

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.

Pricing Debate Innovation

Novartis’ Kisqali Consumer Promos Inappropriately Convey Superiority, NAD Finds In Unusual Ruling

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.

Ad Complaints Advertising, Marketing & Sales

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Latest From Manufacturing

Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate

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. 

Quality Safety

US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections

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.

Manufacturing Regulation

US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA

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.

Manufacturing Legislation
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