Showing posts with label Eye on the FDA Blog Summary of Woodook testimony in front of House committee and Note Regarding Access ot Orphan Drugs Act of 2013. Show all posts
Showing posts with label Eye on the FDA Blog Summary of Woodook testimony in front of House committee and Note Regarding Access ot Orphan Drugs Act of 2013. Show all posts

Friday, July 19, 2013

Eye on the FDA Blog Summary of Woodook testimony in front of House committee and Note Regarding Access ot Orphan Drugs Act of 2013

Eye on the FDA Blog written by Mark Senate of Fleishman-Hillard's Washington, D.C. office has a great summary of  the testimony of Dr. Janet Woodcook, Director of the Center for Drug Evaluation and Research (CDER) before the House Subcommittee on Health, Committee on Energy and Commerce at the hearing entitled "Reforming the Drug Compounding Regulatory Framework."  He states:

  • She set forth a framework that would recognize the two types of compounding – traditional and non-traditional (customizing an existing medication to suit a particular patient versus compounding a drug to meet a specific medical need).  She acknowledged that some products should not be compounded under any circumstances.  She stated that the agency should have the clear authority to collect and testsamples of compounded drugs and collect pharmacy records and that there should be an accurate inventory of pharmacies engaged in non-traditional compounding – all of which might be supported through a user-fee type program. 
He also notes several other pieces of legislation that would impact the FDA have been introduced:
  •  First is H.R.2315 - Preserving Access to Orphan Drugs Act of 2013, introduced by Rep. Jim Gerlach, which would amend the Affordable Care Act (ACA) which would exclude orphan drugs from the annual fee due from manufacturers with sales exceeding $5 million.  The companion bill in the Senate is S.1128 and was introduced by Senator Pat Toomey.