U.S. Regulatory Issues

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• Comments to FDA on the Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic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 Agency Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback" (August 2008)
• 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 Direct Final Rule/Proposed Rule: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma (October 2007)
• 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)
• Comments to FDA on Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments (July 2006)
• Comments to FDA on Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral (October 2005)
• PPTA Statement on Management of Donors and Units that Test Positive for Hepatitis B Virus (HBV) DNA by Nucleic Acid Test (NAT) (July 2005)
• Comments to FDA on Draft Guidance for Industry, "Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection" and Direct Final Guidance, “Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection" (May 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)
• Comments to FDA on Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies (January 2006)
• PPTA Statement on Review of Donor Weight Loss Monitoring (October 2004)
• Comments to FDA on the "Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance." Part 2 (April 2004)
• PPTA Statement on Review of Donor Blood Pressure Requirements (July 2004)
• Comments to FDA on the Draft Guidance for Industry "Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft" Part 1 (April 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)

Industry Issues Impacting Manufacturing Practices

• 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 the Draft Guidance for Industry: Process Validation - General Principles and Practices (January 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 Direct Final Rule: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (February 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: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency (March 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)
• Comments to FDA regarding From Concept to Consumer: Center for Biologics Evaluation and Research Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies; Public Workshop; Reopening of the Comment Period (January 2006)
• Comments to FDA on Public Meeting and Whitepaper - Prescription Drug User Fee Act: Adding Resources and Improving Performance in FDA Review of New Drug Applications (December 2005)
• 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 Improving Transparency in the CBER Regulatory Review Process (December 2004)
• Comments to the FDA on "Industry Representation on BPAC" (November 2004)
• Comments to FDA on the Public Workshop, "Scientific Considerations Related to Developing Follow-On Protein Products" (November 2004)
• Comments to FDA on Solicitation of Comments on Stimulating Innovation in Medical Technologies (August 2004)
• Comments to FDA on Whitepaper "Innovation/Stagnation: Challenge and Opportunity on Critical Path to New Medical Products" (July 2004)
• Comments to FDA on the Draft Guidance, "ICH E2E: Pharmacovigilance Planning (PvP) Draft Version 4.1 on 11th November, 2003" (May 2003)
• PPTA Statement on Contributions of Manufacturing Processes to Prion Removal in the Production of Plasma-derived Therapeutics (February 2004)
• Comments to FDA on the Proposal "Amending the MedWatch Forms to Collect Postmarketing Adverse Events Data Relating to Race and Ethnicity" (February 2004)
• Comments to FDA on the Proposed Rule "Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma" (October 2003)
• Comments to FDA on the Counterfeit Drug Task Force Interim Report (October 2003)
• Comments to FDA on the Proposed Rule "Bar Code Label Requirements for Human Drug Products and Blood" (June 2003)