U.S. Regulatory Topics

• Source Plasma Collection
  
• Industry Issues Impacting Manufacturing Practices

Plasma derived therapies are biological products, subject to regulation by the United States Food and Drug Administration and other government agencies around the world, such as the European Agency for the Evaluation of Medicinal Products. Regulatory authorities prescribe guidance documents, regulations and policy that can be highly detailed and technical, with a scope that covers everything from the collection of plasma through the advertisements and marketing of finished products. PPTA avails itself of opportunities to comment on government initiatives related to the plasma collection and fractionation industries, furthering the industry goal of rational regulatory policy that is based on sound scientific and technical grounds.

At the Plasma Protein Forum in June 2010, officials with the U.S. Food and Drug Administration (FDA) participated in a question and answer session on a variety of regulatory topics including guidance, PDUFA and source plasma collection. A summary of the discussion from that session is captured in this PDF document.
 

Source Plasma Collection

• Comments to FDA on the "Agency Information Collection Activities; Proposed Collection; FDA Recall Regulations" (August 2011)
• Comments to the FDA on the "Compliance Program Guidance Manual: Inspections of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors" (August 2011)
• Letter to Dr. Jay S. Epstein, FDA, regarding the "Blood Products Advisory Committee Meeting and HBV NAT Clinical Sensitivity" (July 2011)
• Comments to HHS on "Request for Information (RFI) to Identify and Obtain Relevant Information from Public or Private Entities with Interest in Biovigilance" (July 2011)

       <--->  See Previous Collection Issues
 

Industry Issues Impacting Manufacturing Practices

• Comments to FDA on " Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus" (January 2012)
• Comments to FDA on "Proposed Rule Amending FDA December 29, 1992 Orphan Drug Regulations" (January 2012)

•  Comments to FDA on "Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Initial Comment" (January 2012)

• Comments to FDA on "Prescription Drug User Fee Act (PDUFA); Reopening of comment period"(October 2011)

• Comments to FDA on "International Conference on Harmonisation (ICH); Draft Guidance on Q11 Development and Manufacture of Drug Substances" (September 2011)
• Comments to the FDA on "Agency Information Collection Activities: Proposed Collection; Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals" (July 2011)
• Comments to FDA on "Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563" (July 2011)
• Comments to FDA on "Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for FYs 2013-2017" (June 2011)
• Comments to FDA on "Draft Guidance for Industry and Food and Drug Administration (FDA) Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic (PE) Safety Studies Using Electronic Healthcare Data Sets" (April 2011)
• Comments to FDA on "Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop"  (April 2011)
• Comments to FDA on "Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations" (April 2011)
• Comments to FDA on "FDA Transparency Initiative: Improving Transparency to Regulated Industry" (March 2011)
• Comments to FDA on "Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information" (January 2011)
• Comments to FDA on "FDA Medical Product Shortages Report" (December 2011)
  
   

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Previous Collection and Manufacturing Issues

Source Plasma Collection (continued)

• Comments to FDA on the Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (December 2009)
• Comments to CDC on the Interim Infection Control Guidance on 2009 H1N1 Influenza for Personnel at Blood and Plasma Collection Facilities (December 2009)
• Comments to FDA on "Transparency Task Force Public Meeting" (August 2009)
• Comments to FDA on the Proposed Rule “Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (August 2008)
• Comments to FDA on the Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes (September 2007)
• Comments to FDA on the Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs (July 2007)
• Comments to FDA on Draft Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs (July 2006)
• PPTA Statement on Management of Donors and Units that Test Positive for Hepatitis B Virus (HBV) DNA by Nucleic Acid Test (NAT) (July 2005)
• Response from FDA regarding 12/17/04 10 lbs. Weight Loss Letter (April 2005)
• PPTA Letter Requesting Clarification of FDA's "Current Thinking" with Respect to Tracking Weight Loss in Plasma Donors (December 2004)
• PPTA Statement on Review of Donor Weight Loss Monitoring (October 2004)
• PPTA Statement on Review of Donor Blood Pressure Requirements (July 2004)
• PPTA Statement of AABB Abbreviated Questionnaire (April 2004)
• Comments to FDA on the Proposed Rule "Safety Reporting Requirements for Human Drug and Biological Products" (October 2003)
• Comments to FDA on the Draft Guidance "Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis" (September 2003) 

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Industry Issues Impacting Manufacturing Practices (continued)

• Comments to FDA on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Hearing" (December 2010)
• Comments to FDA on FDA's Strategic Priorities Document (November 2010)
• Comments to FDA on "Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases; Public Hearing" (August 2010)
• Comments to FDA on "FDA Transparency Task Force: FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration" (July 2010)
• PPTA Presentation at FDA hearing, "Considerations Regarding Food and Drug Administration Review and Regulation of Articles for Treatment of Rare Diseases" (June 2010)
• Comments to FDA on the "Prescription Drug User Fee Act (PDUFA); Public Meeting" (May 2010)
• The Application of ICH S6 to the Preclinical Safety Evaluation of Plasma Derivative Therapeutic Products (August 2009)
• PPTA Comments to FDA on Economically Motivated Adulteration Public Meeting (July 2009)
• PPTA Statement on Clinical and Surrogate Endpoints for Evaluating Efficacy of Alpha 1-Proteinase Inhibitor (Human) Augmentation Therapy (July 2009)
• Comments to NIH on the Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank (June 2009)
• Comments to FDA on Draft Guidance for Industry on Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (April 2009)
• PPTA Statement on Current Considerations on Plasma Obtained from Whole Blood Donors for Further Manufacturing Use (April 2009)
• Comments to FDA on Participation of Certain Population Subsets in Clinical Drug Trials (February 2009)
• Comments to FDA on Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information (May 2008)
• Comments to FDA on Standards for Standardized Numerical Identifier, Validation, Track and Trace, or Authentication for Prescription Drugs (May 2008)
• Comments to FDA on the Draft Guidance for Industry: Cooperative Manufacturing Arrangement for Licensed Biologics (September 2007)
• Comments to FDA on FDA Public Workshop entitled, " Biological Products for Treatment of Rare Plasma Disorders, Addendum" (May 2006)
• Comments to FDA on FDA Public Workshop entitled, " Biological Products for Treatment of Rare Plasma Disorders" (April 2006)
• Comments to FDA on Draft Guidance for Industry: INDs - Approaches to Complying with cGMP During Phase 1 (March 2006)
• Comments to FDA on Anti-Counterfeit Drug Initiative Workshop and Vendor Display (February 2006)
• PPTA Statement on Update of Safety of Albumin (July 2005)
• PPTA Statement on the Rare Bleeding Disorders Workshop (July 2005)
• PPTA Letter to FDA Requesting Removal of 1998 "Dear Doctor Letter" Relating to Albumin from FDA's Website Based on Findings from SAFE Study (December 2004)
• Comments to FDA on the Counterfeit Drug Task Force Interim Report (October 2003)

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