Latest From Sarah Karlin-Smith
Ability to quickly scale manufacturing is a key criteria for Operation Warp Speed therapeutics, but for monoclonal antibodies the most effective approach may mean fewer doses. FDA’s Janet Woodcock said the government is supporting a range of antibody approaches for COVID-19 so that if virus escape mutants emerge from single antibody treatment there will be other options, while Regeneron argues the cocktail approach is safer, even though it will likely mean fewer doses of drug will be available.
Bowing to President Trump’s latest push to authorize the anti-malarial drug for COVID-19 could damage the reputation of the agency for the duration of the pandemic and beyond, experts say, arguing it may be the best example yet of why the FDA’s decision making needs to be more clearly delineated from the country’s political leadership.
Pharma has won pricing battles during the pandemic, but doesn’t seem to be winning war as senators on both sides of the aisle question how some drug companies were able to skirt controversial intellectual property ownership issues in COVID-19 drug and vaccine agreements with the US government. IP experts say the biggest harm to the government from the contracting language may not be the pricing concerns but the government’s ability to share leanings from the partnerships with other coronavirus development programs.
Congress wants HHS to explain why BARDA scientists were removed from leadership positions on COVID-19 vaccine contracts. It is just one of multiple examples of Democrats raising concerns that Operation Warp Speed could be hurting, not helping the COVID-19 response effort.
Recruiting the right patient population for Phase III trials of COVID-19 vaccines will be a key factor in how fast any candidate can come to market. The challenge, which will likely mean enrolling patients who often are underrepresented in trials, is keeping Moderna's Chief Medical Officer up at night. The company also talked vaccine distribution, what it feels it owes the US government for its financial support, and pricing of its potential mRNA vaccine on a recent New York Academy of Sciences webinar.
Value and outcomes-based purchasing agreements could see a boost under proposed Medicaid rule that CMS says will make it easier for manufacturers to experiment different contracting structures in the commercial health insurance market. CMS says the intent of these agreements is to lower drug prices for commercial payers, but the government acknowledges this is not guaranteed, and health policy experts worry both private payers and Medicaid could end up paying higher prices if the proposal is finalized.