Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Equitable access to pandemic medicines and vaccines will be at the core of the WHO’s future global pandemic treaty. Exactly what this will mean for the pharmaceutical industry remains to be seen, but it is likely that companies wanting access to virus samples and other materials will need to agree to benefit sharing in the form of IP and technology transfer.

Medicines for Europe has urged the European Commission to enshrine security of supply considerations for essential medicines into legislation. Without these, it says, additional cost containment measures for off-patent medicines under consideration by member states could threaten access by making production unsustainable for manufacturers.

Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.

Institute for Clinical and Economic Review analysis of whether payers are providing “fair access” to fairly priced drugs was hampered by a lack of transparency among payers, leading to calls for reform.

Chronic migraine and anti-inflammatory treatments were most often subject to step therapy, Tufts researchers found. Policies varied from payer to payer, raising concerns over the impact of shifting requirements for treating the same disease as patients move among insurers.

US FDA staff acknowledge the challenge of assessing promotions on the internet as experts note trends and topics for future research, including the use of metadata and embedded advertisements, TikTok promotions, and DTC ads extending into countries that prohibit them.

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

It is time for payers to stop passively accepting uncertainty and instead help to generate evidence on new medicines, says Hans-Georg Eichler from Austria’s association of insurers.

Pre-registration of study protocols will be voluntary and concerns with revealing proprietary information, among other issues, could be a deterrent to participation. But the developers of the registry hope that researchers will conclude the benefits of doing so outweigh the risks.

While Democratic politicians – and most voters – want to see drug pricing negotiations introduced in the US for the first time, pharma leaders still believe a deal on out of pocket costs will be agreed instead.

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.

Loan program launched in June 2020 to strengthen domestic supply chains for COVID-19 response was deluged with applications, but has not completed any loans, and the GAO has a good idea why.

While better than one its ‘best case’ scenarios, FDA has completed just 31% of 15,514 domestic surveillance inspections planned for FY 2021, applications are still being delayed, and foreign inspections have for the most part yet to be tackled.