Food Safety

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On February 8, 2016, the U.S. Food and Drug Administration (FDA) issued a Product Problem Report concerning the following device: Merge Hemo Programmable Diagnostic Computer, manufactured by Merge Healthcare. The Merge Hemo device monitors, measures and records physiological data from patients undergoing cardiac catheterization procedures and transfers this data to a monitoring station that runs on a personal computer.  This FDA report is the first identifying antimalware as the cause of a medical device failure.

The use of cannabis for restricted medical purposes is set to be legalised in Victoria following the passing of the Access to Medicinal Cannabis Bill 2015.  The Bill creates a new legal regime that regulates the cultivation, manufacture and supply of cannabis in Victoria, and allows for specified categories of patients to have access to cannabis for medicinal purposes.

On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition in section 503B of the FDCA. The FDA intends that its clarifying policies will ensure greater protections for patients whose needs cannot be met by an FDA-approved drug product.

On April 6, 2016, the Food and Drug Administration (FDA) published the final rule for the sanitary transportation of human and animal food.  The rule aims to prevent food contamination during transportation by requiring covered entities involved in transporting human and animal food to follow recognized best practices for sanitary transportation.  The rule seeks to prevent unsanitary practices such as the failure to properly refrigerate food, the inadequate cleaning of vehicles between loads, and the failure to properly protect food. 

On March 22, 2016, the US Food and Drug Administration (FDA) issued a safety announcement that includes required labeling changes for immediate-release (IR) opioid pain medication (and the entire class of opioid drugs) and recommendations and information for patients and health care professionals.  The FDA’s new safety warnings and required labeling changes come shortly after the Senate unanimously passed Senate Bill 483 (114th Congress) on March 17, 2016 requiring greater federal oversight of opioid prescribing practices.

On March 16, 2016, the U.S. Senate voted 48-49 against invoking cloture to cut off a filibuster on the Biotechnology Labeling Solutions Act.  The bill would have established a federal standard of voluntary labeling and preempted any mandatory GMO labeling state laws.  In July 2015, a similar bill called the  Safe and Accurate Food Labeling Act of 2015 successfully passed through the U.S. House of Representatives.[1]  In October 2015, the U.S. Senate Committee on Agriculture, Nutrition & Forestry held a hearing on the mandatory labeling of genetically engineered crops that focused on the House bill.

As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article.  Shortly afterward, Amarin and the government entered settlement talks.  August 31, 2015 update. We are now able to report that on March 8, 2016, the parties entered into a proposed Settlement Agreement resolving all causes of action in Amarin’s suit against the FDA.

On March 1, 2016, the U.S. Food and Drug Administration (FDA) issued guidance on screening donors of human cells, tissues, and cellular and tissue-based products for risk of evidence of infection with Zika virus. The FDA’s guidance identifies Zika virus as a relevant communicable disease agent or disease (RCDAD) and provides recommendations for reducing the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products.