Editors' (re)View: Pandemic disagreements; GDUFA research recap

May 31, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 27

Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.

Pandemic disagreements 

For more than two years now, reps from WHO member states have been working together to draft a pandemic agreement. The goal was to have it done by the World Health Assembly — currently underway now — so that the final text could be voted on. It never happened.

The agreement was supposed to enhance collaboration between countries while simultaneously addressing the gaps that appeared between rich and poor countries when it came to access of COVID treatments and vaccines. “This includes greatly enhancing international cooperation to improve, for example, alert systems, data-sharing, research and local, regional and global production and distribution of medical and public health countermeasures such as vaccines, medicines, diagnostics and personal protective equipment,” wrote Boris Johnson and other national leaders in 2021.

But WHO members were unable to agree on a revised draft in time. WHO released a draft in October 2023, and it was met with immediate backlash, for varying reasons.

Human rights groups said it failed to adequately address human rights concerns — a fundmental tenet of the treaty to begin with. The Lancet called it “shameful and unjust” for similar reasons.

The pharma industry's largest trade group, PhRMA, warned that as it stood, the treaty draft would “undermine biopharmaceutical innovation and collaboration,” citing the waving of IP rights and transparency of clinical trials as red flags.

Republican governors, for their part, recently sent a letter to Biden saying the treaty would give the WHO too much power and would “undermine national sovereignty, infringe upon states’ rights, and jeopardize constitutionally guaranteed freedoms.”

The one thing everyone seems to agree on is that there will be another pandemic. Those involved with the treaty are estimating it could take another 1-2 years of negotiations to get it right. It's important because the treaty should, in theory, solidify much-needed reforms to the global health emergencies preparedness and response framework. But I don't envy them the task of getting everyone on the same page. –Karen Langhauser

GDUFA findings recap

Last week, CDER published its 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Report, sharing research highlights from 2023. Among them, are findings focused on advancements in analytical methods for assessing complex generic drug formulations, improvements in bioequivalence testing for inhaled and injectable generics, and the development of novel strategies for ensuring the quality and efficacy of generic drug products. 

For dealing with impurities, FDA research findings suggest that manufacturers use robust analytical methods like liquid chromatography-high resolution mass spectrometry to detect nitrosamines. The agency recommends that manufacturers use strategies such as using antioxidants and pH modifiers to reduce their formation. FDA issued guidance to this effect, recommending acceptable intakes limits, in August 2023.

When it comes to complex APIs, such as peptides and oligonucleotides, the report discussed findings that point to the advantages of using advanced orthogonal methods for thorough characterization. Research was done hightlighting techniques like nuclear magnetic resonance, diffusion-ordered spectroscopy, and dynamic light scattering for assessing higher-order structures and ensuring bioequivalence and pharmaceutical equivalence.

For complex dosage forms like transdermal systems and liposomal products, the research focus was on both in vitro and in vivo testing methods to evaluate drug release rates, encapsulation efficiency, and stability.

Regarding complex routes of delivery, such as gastrointestinal, buccal/sublingual, inhalation/nasal, ophthalmic/otic, and topical products, the FDA research suggests using physiologically based pharmacokinetic modeling and advanced in vitro testing methods.

The report recap also covered drug-device combination products, stressing the need for thorough testing of device functionality, dose delivery and patient usability. — Andrea Corona

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'