Gottlieb Says FDA Is Encouraging Production Of Complex Generic Drugs To Bring Down Prices
The head of the Food and Drug Administration says in a blog post that his agency will provide guidance to drugmakers on how to win approvals for these medications that are especially hard to make. In congressional testimony, he also says the agency supports "right-to-try" legislation that allows people with serious illnesses access to experimental drugs, but he would like the measure to apply only to people with terminal diseases.
The Associated Press:
FDA Acts To Encourage Generic Competition For Complex Drugs
The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines. Complex drugs and drug-device combinations generally are very expensive and some are widely used. Often, they don't get generic competition right after their patent expires, as happens routinely with pills. (Johnson, 10/2)
FDA Chief Says Agency Will Take Action To Lower Drug Prices
The Food and Drug Administration will take action to deal with the rising cost of prescription drugs, the agency’s head said on Monday. FDA Commissioner Scott Gottlieb said high drug prices are “a public health concern that FDA should address.” (Weixel, 10/2)
FDA Chief Recommends Changes To 'Right To Try'
FDA Commissioner Scott Gottlieb in prepared congressional testimony for Tuesday morning notes the White House supports broadening patient access to experimental medicines via "right to try legislation," but he also suggests ways to narrow the Senate-passed bill so it would apply only to patients with terminal illness. (Karlin-Smith, 10/2)