Showing posts with label Lawmakers Seek Funding Details For FDA's Plan To Oversee Compounding and Oversight Hearing Leaves House Compounding Legislation In Limbo. Show all posts
Showing posts with label Lawmakers Seek Funding Details For FDA's Plan To Oversee Compounding and Oversight Hearing Leaves House Compounding Legislation In Limbo. Show all posts

Saturday, April 20, 2013

Lawmakers Seek Funding Details For FDA's Plan To Oversee Compounding and Oversight Hearing Leaves House Compounding Legislation In Limbo


FDA Week - 04/19/2013

Lawmakers Seek Funding Details For FDA's Plan To Oversee Compounding

Sen. Pat Roberts (R-KS) tasked HHS Secretary Kathleen Sebelius with providing cost information on FDA's plan to ramp up oversight of drug compounding, as the Senate Finance Committee Wednesday (April 17) analyzed the president's fiscal 2014 budget, which did not specify allowances for compounding. Separately, FDA's top official told Senate appropriators that $3 million of fiscal 2013 funds are going toward compounding oversight, but further funding details are dependent on compounding legislation. Roberts and other members of the Senate health committee have been crafting a drug compounding bill, but the lawmaker's funding question signals the low level of detail in FDA's plan, which is driving committee discussions, and raises questions about discussion of an industry fee, sources said.813 words
 

Oversight Hearing Leaves House Compounding Legislation In Limbo

House Republicans probing FDA's oversight of drug compounding said they were not convinced that the agency needs legislation following an Energy and Commerce Committee oversight hearing analyzing documents and agency actions preceding a deadly meningitis outbreak. In analyzing nearly 30,000 pages in documents, committee Republicans and Democrats took opposing stances on FDA's regulatory delays in addressing compounders tied to the outbreak.776 words

Subscription required here