U.S. President Joe Biden signed an executive order Feb. 24 calling for an immediate 100-day review across federal agencies to address vulnerabilities in the supply chains of four key sectors – drugs and active pharmaceutical ingredients; critical minerals; certain batteries; and semiconductors and advanced packaging. The order also calls for a more in-depth, year-long review of the public health and biological preparedness industrial base. As part of the reviews, federal agencies are to identify critical goods and materials within supply chains, the manufacturing or other capabilities needed to produce those materials, and a variety of vulnerabilities created by failure to develop domestic capabilities. They also are to identify the location of key manufacturing facilities, the availability of substitutes or alternative sources for critical goods, the level of workforce skills and the role of transportation systems in supporting supply chains.
The U.K.’s National Institute for Health and Care Excellence (NICE) issued draft guidance Feb. 25 recommending Biomarin Pharmaceutical Inc.’s Kuvan (sapropterin) for treating phenylketonuria (PKU) in children up to 18 years old. Although the drug has been shown to reduce blood phenylalanine levels in people with PKU, NICE said there’s uncertainty about how well it works because there is only short-term trial evidence. Nevertheless, NICE determined that Kuvan could prevent long-term irreversible brain damage in children. Given the limited data, NICE said it doesn’t consider the drug’s use to be cost-effective in adults, whose neurological development is complete. Comments on the draft are due by March 16.
The U.S. Government Accountability Office said it has issued 16 recommendations intended to improve the federal response to the COVID-19 pandemic, but only one of those recommendations has been adopted. That recommendation is for the FDA to work with sponsors to release scientific review data from applications for COVID-19 therapies and vaccines. Some of the unheeded recommendations would address testing issues, supply problems and vaccine distribution.