Backup Drug Manufacturing Facilities Needed
There is a shift toward making more than one medication in a facility as companies seek to cut costs, more mergers take place, and manufacturing is outsourced. However, this consolidation is raising concerns about an increased risk of drug shortages, according to Kaiser Health News. If a facility shuts down, hundreds of drugs could be affected, as happened in Ohio when a plant was shut down after issuing more than 40 drug recalls. The resulting closure created shortages for more than 200 medications. The only way to address the issue is to have backup manufacturing locations.
FDA Strikes Back at Trump’s “Slow” Description
Days after President Donald Trump said in his address to the joint session of Congress that the FDA was “slow and burdensome,” former and current agency officials are speaking up. According to The Washington Post, they say the attacks are unfair and that drug reviews are faster than in recent decades. In fact, the United States usually beats other regulators around the world. In 2016, the median review time for a drug approval was 10 months compared with 27 months in 1993.
Zika Virus Sharply Increases Likelihood of Babies Born With Birth Defects
Compared to before the Zika epidemic, women who contracted the virus during pregnancy are 20 times more likely to have babies with certain birth defects, reported The New York Times. The CDC analyzed hundreds of pregnant women in the Zika Pregnancy Registry and compared their birth outcomes to those in historic registries. The typical rate of severe birth defects had only been 3 out of every 1000 live births in 2013 and 2014, according to registries in 3 states.