Warren bill would get feds into generic drug manufacturing – POLITICO

Warren is one of several senators eyeing White House runs who have introduced bills targeting the pharmaceutical industry. Just last week, Sens. Jeff Merkley (D-Ore.), Kamala Harris (D-Calif.) and Amy Klobuchar (D.-Minn.) introduced the CURE High Drug Prices Act, which would allow the federal government to block price increases on certain drugs. Merkley put forward separate legislation, the Low Drug Prices Act, weeks earlier. And Sen. Bernie Sanders (I-Vt.) introduced his own bill, the Prescription Drug Price Relief Act, in November.

The flurry of bills suggests that the powerful pharmaceutical industry will be a major populist target during the Democratic presidential primary and possibly the general election, as millions of Americans struggle with rising health care costs.
— Read on www.politico.com/story/2018/12/17/elizabeth-warren-bill-drug-manufacturing-prices-1067916

An Office of Drug Manufacturing. That could be interesting.

International Plan of Mystery: ICH Guidelines for Generic Drugs

Back in October, FDA announced that it submitted a proposal to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the development of common global standards for generic drugs.
— Read on www.fdalawblog.net/2018/11/international-plan-of-mystery-ich-guidelines-for-generic-drugs/

Interesting blog post on FDA’s thoughts on the ICH creating some standards on generics.