Tag: FDA

Blog Posts (33)

June 22, 2015

At Long Last: FDA Changes the Law for Hemochromatosis

by Arthur Caplan, Ph.D.

Summer in the U.S. is known for many things—time at the beach, picnics, baseball, thunderstorms, vacations and ice cream.…

October 6, 2014

Misdirected Anger With the FDA Commissioner’s Rather Perfunctory Role?

<p><span style="line-height: 22.3999996185303px;">The September 24, 2014, issue of </span><em style="line-height: 22.3999996185303px;">USA Today</em><span style="line-height: 22.3999996185303px;"> carried a story titled, “<a href="http://www.usatoday.com/story/news/nation/2014/09/24/addiction-painkillers-fda-margaret-hamburg/16150421/">Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.</a>” </span><span style="line-height: 22.3999996185303px;">The first sentence of the news report says: “Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.” ABC News reported the story that same day with the lead, “<a href="http://abcnews.go.com/Health/print?id=25717411">Anti-Addiction Groups Call for New FDA Chief.</a>” </span><span style="line-height: 22.3999996185303px;">In the written ABC News commentary, the hype may be characterized in one inflammatory sentence: “In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called <a href="http://www.zogenix.com/content/products/zohydro.htm">Zohydro</a> [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], </span><span style="line-height: 22.3999996185303px;">against the recommendation of its own medical advisers.” Both the print and newscast reports came from an <a href="http://bigstory.ap.org/article/fda-chief-defends-approval-hydrocodone-drug">Associated Press report</a> written by Matthew Perrone about a controversy that has been brewing for sometime. </span><span style="line-height: 22.3999996185303px;">The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is <a href="http://feduprally.org/wp-content/uploads/2014/09/Burwell-Letter-completed-with-signature-Final.pdf">available online</a> and states their position clearly. </span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
September 2, 2014

Big Data Peeps At Your Medical Records To Find Drug Problems

[NPR] No one likes it when a new drug in people’s medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke. To do a better job of spotting unforeseen risks […]
July 1, 2014

Supreme Court Rejects Contraceptives Mandate for Some Corporations

[The New York Times]  The Supreme Court ruled on Monday that requiring family-owned corporations to pay for insurance coverage for contraception under the Affordable Care Act violated a federal law protecting religious freedom. It was, a dissent said, “a decision of startling breadth.” The 5-to-4 ruling, which applied to two companies owned by Christian families, opened the door […]
June 23, 2014

Teen Suicide Attempts Rise as Warning Cuts Medicine Use

[Bloomberg] A widely publicized warning by U.S. regulators a decade ago about risks for teenagers taking antidepressants led to plummeting prescriptions and increased suicide attempts, Harvard University researchers said. As the public took the Food and Drug Administration’s 2004 warning to heart, adolescent attempted suicides increased 21.7 percent and a 31 percent decline in antidepressant […]
May 16, 2014

Advocating Pill, U.S. Signals Shift to Prevent AIDS

[The New York Times]Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus that causes it.If broadly followed, the advice could transform AIDS prevention in the United States — from reliance on condoms, which are effective […]
May 8, 2014

Nobel laureate Yamanaka denies image manipulation in 2000 paper

Original commentary by BEI Young Professionals Olivette Burton MBe MSW Asking for forgiveness rather than permission is, unfortunately, becoming a recurring international theme in the world of biomedical research.  Questions surrounding trust and integrity in science inevitably become more difficult for honest champions of research to answer convincingly.  Some of my previous work has been dedicated […]
May 5, 2014

State Defends Ban on Powerful Painkiller Zohydro

<p>The governor of Massachusetts <a href="http://www.boston.com/news/local/massachusetts/2014/04/14/state-asks-judge-uphold-emergency-ban-powerful-painkiller-zohydro/VgOBt3e76mRZwBm5yxsDFM/story.html">placed an emergency ban</a> on Zohydro ER (Extended Release), a Schedule II controlled substance that is hydrocodone bitartrate in extended-release capsules.  The easily crushed capsules contain 50 milligrams of pure hydrocodone, which is 10 times more that a regular Vicodin. The FDA approved the drug with a few conditions attached last December although FDA’s advisors voted 11-2 against approving the drug due to concerns about addiction. Governor Patrick does not want the drug in his state until Zogenix, the pharmaceutical company that manufactures the drug, develops an abuse-deterrent version of the drug. He believes that adequate measures are not in place to safeguard against the potential for diversion, overdose and misuse. He was not alone in his concerns.  State attorneys general urged the FDA to reconsider and Congress called a hearing and a bill was introduced by West Virginia Senator Joe Manchin to force the FDA withdraw the drug. </p> <p>Zohydro supporters view it as a very important drug to treat chronic pain in fewer doses than hydrocodone therapies that are shorter acting and contain acetaminophen.  The <a href="http://www.fda.gov.newsevetns/newsroom/pressannoincements/umc372287.htmnaccess">battle began</a> when “Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data.  The product’s release requires post-marketing studies as part of a Risk Evaluation and Mitigation Strategy (REMS) to assess serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long term use beyond 12 weeks.”   Though Zohydro is the first drug to undergo these studies, other extended release (ER) and long acting (LA) opioid analgesics will also be studied in this manner. <a href="http://ir.zogenix.com/phoenix.zhtml?c=220862&amp;p=irol-newsArticle_print&amp;ID=1916462&amp;highlight= ">Practioners are recommended</a> to limit the use of Zohydro to patients whom alternative treatment options such as non-opioid analgesics or immediate-release opioids are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.    </p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
April 30, 2014

New Painkiller Rekindles Addiction Concerns

[New York Times] The abuse of prescription painkillers has reached epidemic proportions in America. Nearly half of the nation’s 38,329 drug overdose deaths in 2010 involved painkillers like hydrocodone and oxycodone, according to the Centers for Disease Control and Prevention. These narcotics now kill more adults than heroin and cocaine combined, sending 420,000 Americans to emergency rooms each year. […]
November 8, 2013

The Fat-That-Must-Not-Be-Named

by Craig Klugman, Ph.D.

As you may have heard, the FDA is considering changing its recommendations concerning partially hydrogenated oils, or what are commonly known as trans fats.…

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Published Articles (4)

American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010

A Response to Commentaries on ?Blood Donation, Deferral, and Discrimination?

American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010

Blood Donation, Deferral, and Discrimination: FDA Donor Deferral Policy for Men Who Have Sex With Men

American Journal of Bioethics: Volume 8 Issue 4 - Apr 2008

Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

American Journal of Bioethics: Volume 8 Issue 3 - Mar 2008

Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

News (7)

May 17, 2012 9:51 am

FDA panel backs at-home HIV test that analyzes mouth swab in 20 minutes (CBS News)

An at-home HIV test that claims to diagnose the disease in 20 minutes from saliva on a mouth swab is a step closer to hitting store shelves, now that an advisory panel of experts recommended the test kit’s approval to the Food and Drug Administration.

May 14, 2012 11:44 am

FDA Issues Warning About Experimental MS Therapy (ABC News)

CCSVI therapy, which has not yet been tested in clinical trials, consists of widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents, both commonly used to treat atherosclerosis, or hardening of the arteries. The intervention is sometimes known as “liberation therapy,” or a “liberation procedure,” the agency said. But the FDA added that so far, it has not approved the use of balloon angioplasty devices or stents to treat CCSVI. It also encouraged clinical trials that could solidify the link between the two conditions, and urged patients to discuss the risks and benefits of CCSVI therapy with their doctors.

May 14, 2012 10:06 am

IOM calls for more thorough safety monitoring of drugs (American Medical News)

To track a medicine’s safety, the FDA should create a comprehensive benefit and risk assessment and management plan that is readily accessible to the public and easy to understand, according to the report, issued May 1. Such a document would give physicians and others greater access to information about drugs on the market than they had in the past, said Eric M. Meslin, PhD, a member of the 12-person IOM committee that wrote the report.

May 4, 2012 1:35 pm

FDA recommended to continue monitoring drugs' safety after approval (News-Medical)

The FDA-which asked the IOM to “convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs”-already collects much of the suggested information, but the data are scattered across multiple records rather than amassed in one central location. “Decentralized records make it difficult for physicians, policy makers and consumers to easily assess information about risks and benefits that accrue over time,” Faden notes.

May 1, 2012 5:07 pm

Better Ways Needed to Track Drug Safety: Report (US News)

A management plan to gather, assess and respond to data about all medications’ risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.

April 22, 2012 11:57 am

FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics (Medical News Today)

On Friday, the US Food and Drug Administration (FDA) proposed two new draft guidelines for the evaluation and use of nanomaterials in food and cosmetics. The agency said in a Consumer Update that this is the continuation of a “dialogue” that started in June 2011, when they issued a draft of the first guideline on the subject, one that helps industry decide whether an FDA-regulated product involves the use of nanotechnology, by considering for instance the size and properties of the materials.

March 26, 2012 1:34 pm

FDA Told to Act on Farm Antibiotics (Wall Street Journal)

A federal judge ordered the Food and Drug Administration to restart a process that could limit the use of two types of antibiotics in cattle, pigs and poultry, amid concerns such use leads to antibiotic-resistant infections in humans.