FDA

  • Read more: Symposium on Institutional Corruption and Pharmaceutical Policy

    Symposium on Institutional Corruption and Pharmaceutical Policy

    By The Petrie-Flom Center The Edmond J. Safra Center for Ethics at Harvard University has organized a symposium on Institutional Corruption and Pharmaceutical Policy that will be published in the forthcoming issue of the Journal of Law, Medicine & Ethics, 2013: Vol. 14 (3).  It will be published at the begining of September. The goals of…

  • Read more: “How I Stopped Worrying and Learned to Love Test Tube Meat (and Started Thinking It May Be Immoral NOT to Eat It)” Or “Hooray For Chickie Nobs!!??!!”

    “How I Stopped Worrying and Learned to Love Test Tube Meat (and Started Thinking It May Be Immoral NOT to Eat It)” Or “Hooray For Chickie Nobs!!??!!”

    By I. Glenn Cohen If you were watching television this week you may have seen this clip of a taste test for hamburger meat grown in a “test tube” in London discussed here. The meat was grown from stem cells from existing cows used to grow 20,000 strands of tissue. Costing more than $330,000 to…

  • Read more: End the Ban on Blood Donation by Gay Men

    End the Ban on Blood Donation by Gay Men

    By Dov Fox 86 members of the U.S. Congress have requested an end to the federal policy that prevents men who have had sex with men from giving blood. Advances in blood screening technology have discredited the medical justification for this exclusion. And our country’s current critical blood shortage makes it dangerous for public health.…

  • Read more: Importing unapproved drugs: lethal injections and shortages

    Importing unapproved drugs: lethal injections and shortages

    By Nicholson Price In a unanimous opinion (pdf) in Cook v. FDA, the DC Circuit just held that FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad. In this case, a set of prisoners on death row sued FDA to require it to prohibit the importation…

  • Read more: Art Caplan: Ease US Blood Supply Shortage by Lifting Gay Donor Ban

    Art Caplan: Ease US Blood Supply Shortage by Lifting Gay Donor Ban

    By Arthur Caplan Art Caplan has published an opinion piece at NBCNews.com calling for an end to the ban on blood donation by gay men in the United States: The United States is facing a health care crisis. Our supply of blood is dangerously low. The American Red Cross reports that across the nation blood…

  • Read more: How global regulations are written

    How global regulations are written

    By Kevin Outterson In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change…

  • Read more: Overdose Prevention Marches On

    Overdose Prevention Marches On

    By Scott Burris Training lay people to reverse opiate overdose with naloxone continues to gain steam in the evidence base, popular media and legislatures. Here’s a great blog post the covers recent developments and links to a new film.  The Open Society Foundations and a group of harm reduction groups have launched a new website to…

  • Read more: Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

    Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

    By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H. Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon…

  • Read more: A Decade’s Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers

    A Decade’s Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers

    By Mary Ann Chirba and Alice A. Noble On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment).  Congressional efforts to enact comprehensive legislation to improve…

  • Read more: GM Crops and the Environment

    GM Crops and the Environment

    By Joanna Sax I’ve become increasingly interested in GM crops, in general, after the recent Petrie-Flom Conference on the FDA in the 21st Century. I know there is a lot of discussion and controversy about genetically-modified (GM) crops.  I want to pick-up on a topic that is related to GM crops – that is, the…