The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable … Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Food & Health Care Industries.
Some important developments during June include:
- Chinese drug company to build production and training center in U.S.
- Drug company challenged for environmental contamination in China
- China's national biomedical plan to be released soon
- Issuance of administrative measures for device recalls
- Designation of four professional associations to examine Class III medical technology
- Extension of Drug GMP certificates
- Recall of an antibiotic… Continue Reading
As every product liability lawyer knows, a client's voluntary recall of a product will result in lawsuits. Plaintiffs' lawyers for pharmaceutical product liability cases love using the fact of a recall as an easy stand-in for proving that the product in a specific case was in fact defective at the time of manufacture. So while equating a voluntary recall with the existence of a defect is a seductively persuasive assumption, defense lawyers should strenuously argue against it because it's an argument they can win.… Continue Reading
On September 30, the House Energy and Commerce Committee is holding a hearing on draft drug safety legislation (per http://energycommerce.house.gov/index.php?option=com_jcalpro&Itemid=54&extmode=view&extid=230&date=2010-09-30, witness list not yet available). The legislation, which was drafted by Reps. John Dingell, Henry Waxman, Frank Pallone, and Bart Stupak, requires parity between foreign and domestic drug facility inspections, increases the number of pre-approval drug inspections, prohibits the entry of drugs into the United States lacking documentation of safety, requires manufacturers to ensure the safety of their supply chain, and grants FDA authority to mandate recalls of unsafe drugs. For background information on the draft legislation (including the text), see http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2123:waxman-dingell-pallone-a-stupak-open-discussion-on-potentially-historic-changes-in-drug-safety-laws&catid=122:media-advisories&Itemid=55&layout=default&date=2010-10-01.… Continue Reading
Recent events highlight the importance of having a plan for product recalls. The Food and Drug Law Institute's recent monograph entitled, "International Prescription Product Recalls: A Practical Guide, Volume 1, Number 4," provides comprehensive guidance and practical recommendations on dealing with recalls internationally as well as a checklist and valuable "dos and don'ts" for manufacturers facing product recalls. Written by Reed Smith partners James M. Wood and Areta L. Kupchyk, the publication is available for download by series and individual issue subscribers.
For more information or to order, see www.fdli.org.… Continue Reading
China's long-awaited Tort Liability Law, passed on December 26, 2009 by the Standing Committee of the National People's Congress of China, will take effect on July 1, 2010. The law, which serves to provide a stronger basis for the development of tort law and practice in China, offers standard guidance on issues ranging from product liability, environmental pollution, medical malpractice to employee-related liabilities. For example, prior to the enactment of the law, defective product recall obligations were only applied to a limited number of products, including medicine, food, toys and automotive products. The new law, however, expands the recall system to cover all products manufactured or sold in China.… Continue Reading
This post was written by Catherine A. Durkin and Areta L. Kupchyk. On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System”—a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. In … Continue Reading
It seems like a rare day when there is not a notice of a foreign-made defective product being recalled in the United States. In recent months, there have been more than 500 recalls of a variety of products including millions of toys coated with lead paint, thousands of illegal fireworks, contaminated meats, and tainted medicines. … Continue Reading