"My goal has always been to draw a clear line on defining what a traditional compounding pharmacy is, and that should be regulated by the States, and what a manufacturer, a drug manufacturer is, which ..."
"But, honestly, all the laws in the world are not going to save a single patient if there is no one enforcing the law."
"Who at the Food and Drug Administration has been fired over this incident? Again, 53 Americans died, 700 are living with a disability."
"Let's put pen to paper and make sure the bad actors are not able to hide from clear enforcement authority."
"Considering that they are more similar in function to manufacturers, should they be regulated within the manufacturing framework?"
"Would it be better to regulate large-scale compounders under the manufacturing standards rather than establishing a new category?"
"Under the proposed Senate framework, FDA would be barred from requiring compounding manufacturers to submit NDAs and ANDAs pre-inspection and labeling requirements before these drugs reach patients."
"The chair thanks the gentleman and now recognizes the gentleman from Virginia, Mr. Griffith, for 5 minutes for questions."
"We have an obligation to ensure that the program provides quality health care to beneficiaries and has the flexibility to innovate to better serve this population."
"We must first address these issues in the current program."
"Medicaid should be structured in a way that provides benefits to individuals in the most efficient and effective way."
"the expansion of the Medicaid program under the Affordable Care Act is not only something that makes tremendous sense for the health of vulnerable populations across the country, but for State economi..."