USLegal Reporter » Health Law

H1N1 Virus Declared a National Emergency

Dana Altman — Tue, 27 Oct 2009 17:57:24 +0000

In order to make it easier for medical facilities to provide treatment, President Obama has declared the 2009 H1N1 virus pandemic a national emergency. The move allows more freedom for off-site, alternate care facilities to be established and a waiver of standard requirements for Medicare, Medicaid and other federal health insurance programs on a case-by-case basis.

Due to manufacturing delays, the government has revised early estimates that as many as 120 million vaccine doses would be available by mid-October. As of October 21, 2009, only 11 million doses had been shipped to health departments, doctors’ offices and other providers across the country, the CDC said. The government now projects about 50 million doses of swine flu vaccine out by mid-November and 150 million in December.

The flu has hit children and young people hardest. Children, pregnant women and people with underlying health issues are being asked to be given preference in receiving the vaccine. Some reports are suggesting that one dose may not be enough, and two are being recommended by Europe’s drugs watchdog, the European Medicines Agency.

Sources: http://www.washingtontimes.com/news/2009/oct/25/h1n1-a-national-emergency/

http://www.cdc.gov/flu/weekly/

Ban on Federal Funding for Stem Cell Research Lifted

Dana Altman — Tue, 10 Mar 2009 20:33:48 +0000

President Obama signed an executive order reversing the previous administration’s ban on funding of human embryonic stem cell research. President Bush signed an executive order in 2001 restricting funding of such research to several dozen pre-existing cell lines. In 2006, Bush vetoed an act which was passed by the Senate to remove restrictions on embryonic stem cell research, saying he opposed federal funding for stem cell research because many consider the destruction of embryos to be murder.

Embryonic stem cells have the ability to transform into any type of tissue or cell in the body. They are also more abundant than adult stem cells, which come from several different parts of the body. Research with embryonic cells has been claimed to provide potential therapies for blindness, spinal cord injuries, heart attacks and diabetes. Only one embryonic stem cell therapy, involving a possible cure for spinal cord injuries, has already received the necessary approval from the Food and Drug Administration to begin clinical trials.

Source: http://jurist.law.pitt.edu/paperchase/2009/03/obama-reverses-stem-cell-research-ban.php

US Court of Federal Claims Autism Rulings

Della Sellers — Thu, 12 Feb 2009 23:39:05 +0000

The US Court of Federal Claims ruled today that three cases filed by families with autistic children who contended the autism was caused by the Measles, Mumps and Rubella (MMR) combination vaccine and thimerosal-containing vaccinations lacked sufficient evidence. The court originally ordered separate trials for cases brought against the US Department of Health and Human Services seeking compensation from the National Vaccine Injury Compensation Program under three different liability theories. The ruling today related to the first theory that the MMR vaccines combined with the thimerosal vaccines can cause autism. Cases will continue relating to the second theory of liability that the thimerosal vaccine can cause autism on its own, while the families have dropped the cases based on the third theory of liability- that the MMR vaccine can cause autism on its own.

The US Department of Health and Human Services issued a statement following the ruling that it will continue to support autism research.

Source: http://jurist.law.pitt.edu/paperchase/2009/02/federal-court-rejects-cases-linking.php

Nebraska Calls Special Session Regarding Safe Haven Law

Della Sellers — Thu, 30 Oct 2008 18:55:43 +0000

Nebraska’s Governor, Dave Heineman, Wednesday called for a special legislative session on November 14 to revise the state’s recently passed safe haven law. Originally, the governor planned to wait until January when the legislature reconvened, but the date has been moved up due to continued abandonment by parents and guardians of pre-teens and teenagers.

The current law, which became effective in July, allows the drop-off of children at a licensed hospital without fear of prosecution, but does not limit the age of such children. As a result, around 23 teens and pre-teens have been abandoned with parents citing uncontrollable and violent behaviors. The intent of the law was to protect children who are in immediate danger of being harmed by panicked mothers. The revisions will limit the safe haven to three-day old infants.

Source: http://jurist.law.pitt.edu/paperchase/2008/10/nebraska-governor-calls-special.php

FDA Says it Will Now Post List of Drugs With Safety Concerns

carrie — Fri, 05 Sep 2008 22:20:06 +0000

The U.S. Food and Drug Administration said today that it will start posting a quarterly report on its website of medications that are being reviewed for potential safety issues.

The first list of 20 drugs was posted today. Medications include Desflurane, Heparin, Icodextrin, Insulin U-500, and Nitroglycerin. Potential problems associated with the medications are also noted.

The new safety information is being distributed to consumers as a result of the 2007 Food and Drug Administration Amendments Act. The act now requires the FDA to post quarterly information on potential drug risks, based on a review of adverse event reports submitted by doctors and hospitals.

The FDA emphasizes that just because a medication is noted does not mean that patients should stop taking them, but rather the list is part of an effort to alert patients earlier of potential side effects. Patients should consult their health care providers if they have further questions.

Sources:

http://www.fda.gov/cder/aers/potential_signals/default.htm

http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm

FDA Orders Tougher Warnings on Arthritis Drugs

carrie — Thu, 04 Sep 2008 21:48:23 +0000

The Food and Drug Administration today called for the makers of four medications used to treat arthritis and other conditions to strengthen their warnings to consumers. The drugs in question are Humira, Cimzia, Enbrel, and Remicade.

The FDA says patients who take the medications need to be better advised of the risk of developing opportunistic fungal infections. Some individuals with such fungal infections have died.

Under the Food and Drug Administration Amendments Act of 2007, the FDA can now require drug manufacturers to make safety-related changes to prescribing information or labeling. Manufacturers must now submit proposed safety label changes to the FDA within 30 days or provide a reason why they do not believe the changes are necessary.

Source: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html

FDA Allows Lose Dose Radiation of Spinach and Lettuce

carrie — Fri, 22 Aug 2008 19:07:40 +0000

The Food and Drug Administration today approved irradiation of fresh spinach and iceberg lettuce. The irradiation process will expose the produce to low amounts of radiation designed to kill germs and bacteria such as E. coli and salmonella. The method is also believed to help food last longer and according to the FDA, the produce will not lose its nutrient value.

The FDA says the irradiation process has been tested for more than 40 years and deemed safe to be used on a variety of foods.

Food growers and shippers can voluntarily decide whether or not to irradiate iceberg lettuce and spinach. However, if they do treat their produce, they must notify consumers. The FDA requires that foods which have been irradiated carry the “radura” label along with the statement “Treated with radiation” or “Treated by irradiation.”

The FDA continues to recommend that consumers wash fresh and bagged produce before eating it, unless the packaging specifically states that the product has been prewashed.

Source: http://www.fda.gov/consumer/updates/irradiation082208.html

California Attorney General Settles Potato Chip Lawsuit

carrie — Mon, 04 Aug 2008 22:35:05 +0000

California Attorney General Edmund Brown has settled a lawsuit against four major potato chip and french fry manufacturers. Heinz, Frito-Lay, Kettle Foods, and Lance Inc. have all agreed to reduce levels acrylamide, a chemical which has been linked to cancer.

The annoucement was made last Friday.

The attorney general had sued the companies under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act. That act requires companies to post warnings of any cancer-causing chemicals in products unless they can prove that the levels do not pose a significant health risk.

The companies have also agreed to pay costs and fines.

Source: http://ag.ca.gov/newsalerts/release.php?id=1595&

FDA Lifts Warnings on Tomatoes

carrie — Fri, 18 Jul 2008 14:42:43 +0000

The Food and Drug Administration on Thursday said it is safe for Americans to consume tomotoes again. However, the FDA left a warning on hot peppers in place.

More than 1220 people in 42 states have become sick from salmonella since April. Early on it was believed that tomatoes were the source. Now investigators are looking into jalapenos and fresh cilantro as the cause.

Source: http://ap.google.com/article/ALeqM5ijaaf9rEEqJFRI_zJo1YK8TYcBFgD9207F6O0

Salmonella Cases Continue to Climb

carrie — Wed, 16 Jul 2008 18:57:17 +0000

The Center for Disease Control says more than 1,100 people have now been infected with Salmonella Saintpaul which is believed to be linked to eating certain kinds of raw tomatoes. The CDC is also warning consumers that raw jalapeno peppers and fresh cilantro are also now under investigation.

Since April, 1167 persons have contracted Salmonella Saintpaul with the same genetic fingerprint. The outbreak has been identified in 42 states, the District of Columbia, and Canada.

Source: http://www.cdc.gov/Salmonella/saintpaul/#advice