• Regulatory NewsRegulatory News

    HHS Establishes Organ Donation Policy for Patients With HIV

    The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...
  • Regulatory NewsRegulatory News

    FDA Clarifies Syphilis Screening Procedures for Blood, Plasma Donations

    • 28 August 2014
    A new guidance document issued by the US Food and Drug Administration (FDA) finalizes an earlier draft set of recommendations on how blood and plasma collection centers can screen donors and samples for syphilis. Background Blood and plasma donations, like the donation of all cell and tissue products, are already subject to a battery of tests to ensure they are not contaminated with any serious diseases. At present, those tests include ones to detect hepatitis B and C, ...
  • US Blood Donation Process to Become Easier for Recent Travelers to Cancun, Cozumel

    Malaria-a mosquito-borne disease common in some developing countries that kills hundreds of thousands of people each year-is a serious threat to the health of even healthy humans. But as a new guidance document released on 19 August 2013 by the US Food and Drug Administration (FDA) notes, the disease isn't just confined to the developing world. There is a risk, albeit a small one, of malaria being transmitted during blood transfusions-a risk FDA believes is no longer refl...
  • FDA Adopts Expedited Blood Donation Screening Standard

    The US Food and Drug Administration (FDA) has released a final guidance document that it says is intended to expedite the donation of blood and plasma for frequent donors. Background The final guidance, " Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components ," recognizes a standard maintained by the American Association of Blood Banks (AABB) known as the abbr...
  • Warning Letter to Fertility Clinic a Crash Course in Tissue Donation Ethics

    The US Food and Drug Administration's (FDA) weekly batch of warning letters are often a cavalcade of depressing observations and alleged violations of every sort. But an April 2013 letter to Olympia Women's Health stands out for an ethical conundrum of sorts involving two patients trying to conceive a child while confronting the risk of transmitting a disease. Background Olympia is a Washington-based fertility clinic, according to the company's website . As a site that...
  • Update of Blood and Plasma Guidance Calls for Revised Syphilis Screening Procedures

    • 27 February 2013
    A new draft guidance published by the US Food and Drug Administration (FDA) recommends revised screening procedures to guard against the threat of syphilis contamination in donated blood and plasma, taking a multi-pronged approach emphasizing redundant testing and risk mitigation methods. Background The draft guidance, Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis , notes ...
  • Report: Tainted Blood Platelets Pose Greater Risk than HIV-Infected Blood Products

    There's a new top threat to the safety of the nation's blood supply.  The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the status of the most potent threat to patients. Contaminated variants of platelets, which are used to clot blood, have been blamed in nearly two dozen deaths and hundreds of injuries in recent years. While testing is available to screen donated blood for contaminated...
  • Report: Human Tissue Donation Rules Lack 'Inadequate Safeguards'

    • 18 July 2012
    An investigation into human tissue trafficking by The International Consortium of Investigative Journalists (ICIJ) has uncovered "inadequate safeguards" to protect consumers from poorly-sourced human tissue products. "Despite concerns by doctors that the lightly regulated trade could allow diseased tissues to infect transplant recipients with hepatitis, HIV and other pathogens, authorities have done little to deal with the risks," ICIJ wrote. "In contrast to tightly-mon...
  • Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional'

    A woman is suing the US Food and Drug Administration (FDA) over its policy requiring potential sperm donors to undergo health testing before being allowed to donate, calling the regulations a violation of her constitutional rights. At issue for the woman-an Oakland, California resident known only as "Jane Doe" in the court filings-is whether she can use a trusted male friend as a sperm donor so she may start a family with her female partner without the interference of th...
  • FDA Releases Draft Guidance Changing Blood Donation Criteria

    The US Food and Drug Administration (FDA) has released new draft guidance intended to reduce the risk of transmitting malaria through donated blood. In its 6 June Federal Register posting, FDA said the draft guidance document addresses donor testing, as well as managing donor deferrals and reentry into the pool of blood donors. The purpose of the draft guidance is to "reduce the risk of transfusion-transmitted malaria," FDA wrote in the posting. "This draft guidance d...
  • Lawmakers: Reform 'Indefensible' Blood Donation Policy

    A group of 62 US lawmakers sent US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius a letter on 11 June expressing their collective support for a draft policy announced in March 2012 that would examine the feasibility of relaxing rules currently prohibiting gay men from donating blood or plasma. In DHHS's Request for Information on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for Men Who have Had Sex ...
  • DHHS Reevaluating Blood Donation Rules

    The US Department of Health and Human Services (DHHS) is looking at the possibility of relaxing rules that currently prohibit gay men from donating blood or plasma. The guidelines have been in place since 1977 as a result of fears over "higher levels of certain transfusion-transmissible infections," but the policy has attracted significant amounts of controversy in recent years as blood safety testing experienced dramatic improvements. "As a result, questions have been ...