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Too Slow or Too Fast

Writing in the New York Post, Henry Miller, the founding director of the US Food and Drug Agency's Office of Biotechnology, bemoans the pace at which the agency approves drugs for use.

Miller, who is now at the Hoover Institution, says FDA typically moves slowly on drug approvals. He notes that the European Union, Australia, and Canada have approved Bexsero, a meningitis B vaccine, but not the US. Similarly, he writes that pirfenidone, an idiopathic pulmonary fibrosis treatment, is available in Europe, Japan, Canada, and China, while there is no treatment for the condition available in the US.

But, he says the agency has moved quickly on expanding access to Ebola treatments and developed a clinical trial so that, after intense social media-based lobbying, a young cancer patient could receive an experimental drug.

"[B]ureaucrats are supposed to make decisions that are dispassionate, data-driven, and in the public interest," Miller opines. "Instead, the FDA moves faster on life-saving treatments mainly when it knows the public is watching."

The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.