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Biological Products

 

Health Hippo: Biological Products

USC || CFR || CASES || REPORTS || CONGRESSIONAL RECORD || BILLS || FEDERAL REGISTER

The body has in itself blood, phlegm, yellow bile and black bile; and through these we feel pain or enjoy health.

Biological products (biologics) represent the cutting edge of medical science and research. Gene-based and cellular biologics, at the forefront of biomedical research today, may make it possible to treat a variety of medical conditions, including illnesses for which no other treatments are available. The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including allergenic extracts, blood and blood components, gene therapy products, devices and test kits, human tissue and cellular products used in transplantation and vaccines. The Center for Drug Evaluation and Research (CDER) within FDA regulates other categories of biological products mostly produced by biotechnology methods, such as cmonoclonal antibodies, cytokines, growth factors, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins, enzymes, thrombolytics and immunomodulators.

U.S. Code

  • Health Insurance Portability and Accountability Act
    • Sec. 371. Organ and tissue donation information included with income tax
      refund payments.

Code of Federal Regulations

  • 21 CFR CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
    • SUBCHAPTER A GENERAL (Parts 1 to 99)
    • SUBCHAPTER F BIOLOGICS (Parts 600 to 680)
      • PART 600 BIOLOGICAL PRODUCTS: GENERAL (600.2 – 600.90)
        • SUBPART A General Provisions (600.2 – 600.3)
        • SUBPART B Establishment Standards (600.10 – 600.15)
        • SUBPART C Establishment Inspection (600.20 – 600.22)
        • SUBPART D Reporting of Adverse Experiences (600.80 – 600.90)
      • PART 601 LICENSING (601.2 – 601.95)
      • PART 606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS (606.3 – 606.171)
      • PART 607 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS (607.3 – 607.65)
      • PART 610 GENERAL BIOLOGICAL PRODUCTS STANDARDS (610.1 – 610.68)
        • SUBPART A Release Requirements (610.1 – 610.2)
        • SUBPART B General Provisions (610.9 – 610.18)
        • SUBPART C Standard Preparations and Limits of Potency (610.20 – 610.21)
        • SUBPART D Mycoplasma (610.30 – 610.30)
        • SUBPART E Testing Requirements for Communicable Disease Agents (610.40 – 610.48)
        • SUBPART F Dating Period Limitations (610.50 – 610.53)
        • SUBPART G Labeling Standards (610.60 – 610.68)
      • PART 630 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES (630.6 – 630.6)
      • PART 640 ADDITIONAL STANDARDS FOR HUMAN BLOOD
      • PART 660 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS (660.1 – 660.55)
        • SUBPART A Antibody to Hepatitis B Surface Antigen (660.1 – 660.6)
        • SUBPART B [Reserved]
        • SUBPART C Blood Grouping Reagent (660.20 – 660.28)
        • SUBPART D Reagent Red Blood Cells (660.30 – 660.36)
        • SUBPART E Hepatitis B Surface Antigen (660.40 – 660.46)
        • SUBPART F Anti-Human Globulin (660.50 – 660.55)
      • PART 680 ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS (680.1 – 680.3)
    • SUBCHAPTER L REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION (Parts 1210 to 1272)
      • PART 1270 HUMAN TISSUE INTENDED FOR TRANSPLANTATION (1270.1 – 1270.43)
        • SUBPART A General Provisions (1270.1 – 1270.3)
        • SUBPART B Donor Screening and Testing (1270.21 – 1270.21)
        • SUBPART C Procedures and Records (1270.31 – 1270.35)
        • SUBPART D Inspection of Tissue Establishments (1270.41 – 1270.43)
      • PART 1271 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (1271.1 – 1271.440)
        • SUBPART A General Provisions (1271.1 – 1271.20)
        • SUBPART B Procedures for Registration and Listing (1271.21 – 1271.37)
        • SUBPART C Donor Eligibility (1271.45 – 1271.90)
        • SUBPART D Current Good Tissue Practice (1271.145 – 1271.320)
        • SUBPART E Additional Requirements (1271.330 – 1271.370)
        • SUBPART F Inspection and Enforcement (1271.390 – 1271.440)

        42 CFR Part 121
        42 U.S. Code § 274
        42 CFR 488.61

Cases

  • Hecht v. Superior Court 16 Cal. App. 4th 836 (1993)(ownership over cryobanked sperm could be transferred as property by will to another party)
  • Moore v. Regents of the University of California 793 P.2d 479 (1990)(plaintiff stated a cause of action for breach of disclosure based on use of his cells for potentially lucrative medical research)
  • Diamond v. Chakrabarty 447 U.S. 303 (1980)(bacteria were patentable microorganisms as manufacture or composition of matter under patent law, because applicant produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility)
  • Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S. 127 (1948)(for a product to be patentable, it must be more than new and useful; it must also be a product of invention or discovery. Packaging bacteria into one inoculant was a product of skill, not invention)

Reports

  • Patent and Trademark Office Recent Federal Register documents.
  • What’s New for Biologics New items related to biologics are added to the top of the list as they are posted on the site.
  • Biosimilars Approval Process The Affordable Care Act created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. Under the Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.
  • Biosimilars: Guidance for Industry (FDA 2013) Draft guidance regarding formal meetings between the FDA and biosimilar biological product sponsors or applicants.
  • National Cord Blood Inventory: Practices for Increasing Availability for Transplants and Related Challenges (GAO 2011) The Stem Cell Therapeutic and Research Act of 2005 authorized funding for banking 150,000 new units of high quality and genetically diverse cord blood and directed the Department of Health and Human Services (HHS) to contract with cord blood banks to assist in cord blood collection.
  • Organ Transplant Programs: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain (GAO 2008) The Centers for Medicare & Medicaid Services (CMS) oversees transplant programs that receive Medicare reimbursement, and the Health Resources and Services Administration (HRSA) oversees the Organ Procurement and Transplantation Network (OPTN), which manages the nation’s organ allocation system.
  • Medicare-Approved Heart Transplant Centers (OIG 2004) We analyzed data on Medicare-approved heart transplant centers from 1987 through 2000. Our report did not evaluate whether heart transplants were performed under unsafe conditions. It measures only whether centers continued to meet Medicare’s initial volume and/or survival criteria.
  • Variation in Organ Donation Among Transplant Centers (OIG 2003) Our objective was to describe va riation among transplant centers, which, because of their role in organ transplantation, can be potential national leaders in donation. These data illustrate the wide variation among transplant centers in procuring organ donors. In documenting this variation, our analysis highlights the existing potential to increase the number of organ donors.
  • Blood Supply Generally Adequate Despite New Donor Restrictions (GAO 2002) The average price of blood has risen over 50 percent since 1998. Although blood is primarily collected from volunteers, blood suppliers incur costs by collecting, processing, and testing donated blood.
  • Maintaining an Adequate Blood Supply Is Key to Emergency Preparedness (GAO 2002) Insights from the experiences of September 11 and other disasters have led the task force to conclude that the need for blood in most emergencies can be best met by maintaining an adequate blood inventory at all times, rather than increasing blood collections following a disaster.
  • Organ Donor Registries: A Useful, but Limited, Tool (OIG 2002) We conclude from our review that caution should be exercised to avoid over-promising on the contributions that donor registries, by themselves, can make to increasing donation. We believe that the most appropriate use of Department resources with respect to donor registries is to foster ways of enhancing their effectiveness.
  • Informed Consent in Tissue Donation: Expectations and Realities (OIG 2001) The reality of tissue banking raises some underlying tension with families’ assumptions. 1) Commercialization of tissue banking. Large scale financial operations may overshadow the underlying altruistic nature of tissue donation. 2) Tissue viewed as a commodity. After processing, tissue and products containing tissue often are marketed and sold as a medical supply, rather than as a donation. 3) Cosmetic uses of tissue. Some tissue, particularly skin, may be processed into products that are used for cosmetic purposes that may not be medically indicated.
  • Oversight of Tissue Banking (OIG 2001) This report responds to a request from the Secretary of Health and Human Services, asking the Office of Inspector General to examine the oversight system for tissue banking. We analyzed available data related to tissue banking, and we reviewed regulations, laws, and standards. We interviewed staff from FDA, from 30 tissue banks, and from associations representing various sectors of the tissue banking industry.
  • Medicare Conditions of Participation for Organ Donation: An Early Assessment of the New Donation Rule (OIG 2000) In June 1998, the Health Care Financing Administration (HCFA) changed the Medicare conditions of participation to spur an increase in donation. In this report, we refer to this new condition as the “donation rule.” The donation rule contains two key provisions: 1) Hospitals must contact their organ procurement organization (OPO) in a timely manner about individuals whose death is imminent or who die in the hospital. 2) Only OPO staff or trained hospital staff — referred to as designated requestors — may approach families about organ donation.
  • Fostering Equity in Patient Access to Transplantation: Local Access to Liver Transplantation (OIG 1999) In 1997, 15 States had no liver transplant center within their borders; 45 percent of the U.S. population lived outside of metropolitan areas with liver transplant centers. Most new liver transplant centers have opened in areas where a liver transplant center already operated.
  • Fostering Equity in Patient Access to Transplantation: Differences in Waiting Times for Livers (OIG 1999) Our analysis shows considerable variation in median waiting time for liver transplants among the OPTN regions. For patients with Type O blood, the most common blood type, median waiting time ranged from 123 days to 958 days.
  • Fostering Equity in Patient Access to Transplantation: Differences in Waiting Times for Kidneys (OIG 1999) Our analysis shows considerable variation in median waiting time for kidney transplantation among the OPTN regions. For patients with Type O blood, the most common blood type, median waiting time ranged from 420 days to 1,538 days.
  • Racial and Geographic Disparity in the Distribution of Organs for Transplantation (OIG 1998) Our findings led us to call for an organ allocation system that focuses on (1) equity among patients, not among transplant centers and (2) common medical criteria, not the circumstances of a patient’s residence or transplant center affiliation.
  • Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain (GAO 1997) Evaluating the Food and Drug Administration’s oversight of transplanted human tissue as well as potential safety problems, focusing on: (1) gaps in the current regulation; and (2) whether and how FDA plans to address them in the approach it has proposed for regulating tissue
    banking.
  • Health Insurance: Coverage of Autologous Bone Marrow Transplantation for Breast Cancer (GAO 1996) Although many insurers now cover the cost of autologous bone marrow transplantation, a new and expensive treatment for breast cancer, issues surrounding the procedure have put several goals of the U.S. health care systems in conflict: access to the best, most
    advanced care; cost containment; and research adequate to assess the value of new treatments.
  • Blood Supply: Transfusion-Associated Risks (GAO 1997) The U.S. blood supply is safer today than at any time in recent history, with risks from blood transfusions quite small compared with the benefits of transfusion in saving lives.
  • Bone Marrow Transplantation: International Comparisons of Availability and Appropriateness of Use (GAO 1994). The U.S. health care system has been criticized for encouraging the “overuse” of the newest and most costly medical treatments.
  • Blood Safety: Enhancing Safeguards Would Strengthen the Nation’s Blood Supply (GAO 1997) GAO discussed its two reports on the safety of the nation’s blood supply, focusing on: (1) the current risks of blood transfusion; (2) the content and quality of data collected to assess these risks; and (3) the Food and Drug Administration’s (FDA) layers of safety and
    their ability to ensure the safety of the nation’s blood supply.
  • Organ Procurement Organizations: Alternatives Being Developed To More Accurately Assess Performance. (GAO 1997) GAO reviewed whether the Health Care Financing Administration’s (HCFA) population-based standard
    appropriately measures the extent to which organ procurement organizations (OPO) are maximizing their ability to identify, procure, and transplant organs and tissue, focusing on: (1) the strengths and weaknesses of the current standard; and (2) alternatives to the current standard.
  • NIH-Funded Research:
    Therapeutic Human Fetal Tissue Transplantation Projects Meet Federal Requirements     (GAO 1997) Pursuant to a legislative requirement, GAO reviewed the fetal tissue transplantation research funded by the National Institutex of Health (NIH) under the NIH Revitalization Act, focusing on: (1) compliance with informed consent and other documentation; and (2) any violations occurring in the acquisition of human fetal tissue for use in transplantation.
  • Blood Supply: FDA Oversight
    and Remaining Issues of Safety     (GAO 1997) Pursuant to a congressional request, GAO evaluated the Food and Drug Administration’s (FDA) “layers of safety” that provide the framework for regulating and monitoring the U.S. blood industry, focusing on the actual and potential vulnerabilities in the layers of safety that may present a threat to the public health.
  • Blood Supply: Transfusion-Associated Risks (GAO 1997) The U.S. blood supply is safer today than at any time in recent history, with risks from blood transfusions quite small compared with the benefits of transfusion in saving lives.
  • Organ Procurement Organizations and Tissue Recovery (OIG 1994) Human tissue grafts, from perhaps 10,000 donors, benefit as many as a half-million people annually. The great majority of these transplanted tissues are bones, bone products, or other parts of the musculo-skeletal system, such as tendons, fascia, and soft tissues.
  • Addressing Increased Organ Acquisition Costs (OIG 1991)
    We reintroduce the recommendations, cited below, because (1) the ineffciencies we described in the prior report continue to exist, (2) fiscal oversight of organ procurement organiztions is stil limited and uneven, and (3) kidney acquisition expenditures per transplant appear to be much higher than previously assumed.
  • The Distribution of Organs for Transplantation: Expectations and Practices (OIG 1991) There has been considerable progress in establishing a national system grounded in
    uniform policies and standards for the distrbution of organs. However, organ distrbution remains heavily controlled by the individual transplant centers and confined primarily within the individual service areas of 72 Organ Procurement Organizations (OPOs).
  • Organ Acquisition Costs (OIG 1987) During FY 1985, Medicare expenditures on kidney acquisition and transplantation were an estimated $240million. Of that total, $102 million, about 43 percent, was for kidney acquisition.
  • The Access of Dialysis Patients to Kidney Transplantation (OIG 1987) Although kidney transplant surgeons report that at least 20 to 25 percent of the dialysis population is medically suitable for a transplant, only 10 to 11 percent of that population is on a transplant waiting list.
  • The Access of Foreign Nationals to U.S. Cadaver Organs (OIG 1986) Medicare policy does not require that foreign receiving centers pay the full acquisition cost of exported
    kidneys. As a result, the Medicare program is, in effect, subsidizing much of the acquisition cost of kidneys sent to other countries.

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