Following months of negotiations and examination of legislation to protect patients and improve oversight of pharmaceutical compounding, U.S. Senator Pat Roberts today thanked stakeholders for their feedback and called for swift consideration of the bipartisan bill.
"Following the tragic deaths of 52 people in the recent meningitis outbreak due to contaminated compounded medications, we had to get this right," Roberts said. "I am very proud of this draft bill because it represents months of analysis and bipartisan work to get it right. We wanted industry and patient feedback on the draft and now we will take that into consideration to make this bill even better. I urge my colleagues to join us in making this legislation a priority to protect patient safety."
Roberts made the remarks at a hearing of the Senate Health, Education, Labor and Pensions (HELP) Committee, of which he is a member, on draft legislation he helped to write with HELP Ranking Member Lamar Alexander (R-TN), Chairman Tom Harkin (D-IA) and Senator Al Franken (D-MN) on pharmaceutical compounding.
Roberts pushed back against misinformation on the draft bill.
The draft legislation makes a clear distinction between traditional compounding--which will continue to be regulated primarily by state pharmacy boards--and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the Food and Drug Administration.
This draft legislation clarifies a national, uniform set of rules for compounding manufacturers while preserving the states' primary role in traditional pharmacy regulation.
The Senators will consider stakeholder input, make adjustments and introduce a new bill expected to be marked up by the HELP Committee later this month.