Over the past year, there has been a simmering dispute between hospitals and pharmaceutical companies over the 340B drug pricing program. This week, the United States Department of Health and Human Services weighed in strongly on the side of the hospitals. We also look at the discussion at the World Trade Organization on waiving intellectual property protections for COVID-19 vaccines, the recovery of oncology clinical trials, balancing patient privacy concerns with data needs for artificial intelligence, and new biosecurity laws for mail-order genes.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
A year after a number of pharma companies took action to limit the use of some 340B discounts, HHS has sent notice that the agency has sided with hospitals disputing the practice. Hospitals, now along with HHS, argue that some of the world’s top drugmakers are out of compliance with the 340B statute. The pharma companies argue they are taking reasonable steps to limit duplicate and disqualified rebates. This was a strong message from HHS but likely not the end of the dispute.
Severin Schwan, CEO of Roche, is the latest pharma executive to voice strong opposition to discussions at the WTO of waiving intellectual property protections for COVID-19 vaccines. The proponents of the waivers, including the Office of the United States Trade Representative, argue that something must be done to address vaccine shortages. The industry argues this would set a dangerous precedent and that vaccine manufacturing is limited by raw material availability and technical resources to perform the complex manufacturing processes.
Like all clinical trials, the initial lockdowns and delay of care impacted oncology trials in 2020. However, new research published in the Nature article linked above confirms what companies like Medidata reported anecdotally in real time: that the impact was smaller and the recovery was faster for oncology trials. This additional research better quantifies the impact, including by phase, and highlights that the recovery for clinical trials, like the rest of the economy, is ongoing.
One of the prerequisites for leveraging artificial intelligence in any industry is access to massive libraries of data. In the health care and life sciences space, there is no lack of data but patient privacy protections make it challenging to safely combine data from multiple sources. This article looks at using federated learning as a way to maximize data access for machine learning while minimizing risks for patient privacy.
5. California is updating biosecurity laws to keep pace with rapid changes in synthetic gene technology
Not long ago, creating synthetic genes was a complex, labor-intensive process produced at a small scale in research labs. Now, companies are manufacturing these synthetic genes quickly and economically. Once ready, the genes are boxed up and shipped similar to any other mail-order product. Now, lawmakers in California are working on new biosecurity laws to address screening and the risk of shipping potentially dangerous pathogens.