US Senate Drafts Substantial Changes to Drug Supply Chain Integrity, Medical Device Policies
Posted 19 March 2012 | By
Draft legislation from the Senate Health, Education, Labor and Pensions (HELP) Committee aims to secure the drug supply chain and make numerous and substantial changes to medical device practices at the US Food and Drug Administration (FDA).
The Drug Supply Chain Integrity Act draft calls for
- registration of domestic drug establishments
- registration of foreign establishments
- electronic system for registration and listing
- risk-based inspection frequency
- records for inspection to be made readily available
- failure to allow foreign inspection as grounds for refusal to admit a product into the US
- FDA may keep certain information obtained from foreign government entities confidential and enter in to MOU's to that effect
- enhancing the safety and quality of the drug supply by promoting good manufacturing practices (GMPs)
- accreditation of third-party auditors for drug establishments
- standards for admission of imported drugs
- mandating manufacturers notify FDA of any thefts, counterfeits or unapproved importation of their drug product
- destruction of unsafe drugs
- protection against intentional adulteration by enhancing criminal penalties
- enhanced criminal penalty for counterfeiting drugs
- extraterritorial jurisdiction
- drug distribution security
The Medical Device Policy Draft calls for:
- reclassification procedures
- condition of approval studies.
- postmarket surveillance.
- inclusion of Medical Devices in the Sentinel system.
- a new recall assessment system.
- clinical holds on investigational device exemptions.
- unique device identifier (UDI) system.
- clarification of least burdensome standard.
- agency documentation and review of certain decisions regarding devices.
- good guidance practices relating to devices.
- FDA acceptance of performance standards.
- modification of de novo application process.
- humanitarian use device exemptions.
- reauthorization of third-party review.
- dvisory committee conflicts of interest.
Senate HELP Committee - Chairman Harkin and Ranking Member Enzi Release HELP Drafts for Stakeholder Discussion
Medical Device Policy DraftDrug Supply Chain Integrity Act