Latest From Michael McCaughan
For now, agency appears to be in early stages of testing alternative inspection models beyond the flexibility it has been applying throughout the pandemic.
CEO accountability hearing in US House shows that the COVID-19 outbreak is helping to blunt attacks on the drug industry over its pricing – just not entirely in the way the industry hoped.
Significant resources will likely depend on the next user fee agreement, but the launch of a Digital Health Center of Excellence will help the US FDA better prioritize ongoing work in the emerging field and help to identify needs for new talent, Deputy Commissioner Abernethy says.
A Senate Health Committee update hearing on the COVID-19 federal response was noteworthy primarily for demonstrating that FDA Commissioner Stephen Hahn appears to have salvaged the agency’s position as a voice of credibility with a key political constituency – at least for now.
Before taking over the US health department, Alex Azar helped bring landmark litigation challenging the scope of FDA’s regulatory authority under the First Amendment. Now his tenure is ending with a First Amendment defense of the agency.
In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.