› $4.85 Billion settlement in drug case
Following up on a story we brought you last month about the FDA setting up offices on foreign soil to provide guidance on U.S. food and drug quality standards, the FDA announced today that the first three of its offices will open this week in China, according to the Associated Press.
A recent Time magazine story gives us a glimpse into a family affected by the contaminated heparin tragedy: Leroy Hubley’s wife of 48 years, Bonnie, suffered from polycystic kidney disease, a genetic kidney disease in which cysts grow in the kidneys, causing them to fail. She received a kidney transplant in October 2007, but her body rejected it, leaving her in need of regular dialysis treatments.
ConsumerAffairs.com is reporting that doctors are outraged that recalled batches of heparin were found in a Cincinnati, Ohio lab.
“It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio.
The U.S. Food and Drug Administration (FDA) issued and FDA NEWS release today informing the public that it has removed 11 lots of heparin from Celsus Laboratories, Inc., in Cinncinnati, Ohio. According to the release, the FDA has determined five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were contaminated with over-sulfated chondroitin sulfate (ASCS). The heparin products were manufactured from material imported from China.
The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”
Earlier this year, heparin manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That heparin also contained components manufactured in China, which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.
The FDA news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies, to date this year.
Information in the news release indicates the Celsus heparin entered the United States before the establishment of FDA import controls for the drug, and was reviewed by the FDA after it was processed at Celsus as a part of the agency’s process to implement the controls.
The release also indicates that the FDA knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The FDA says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the FDA seized the contaminated product from the lab.
Manufacturers who may have purchased heparin from Celsus are urged to contact the company immediately to make sure they are not using any heparin from the since-seized lots. The product does not meet acceptable quality standards, the release says.
The U.S. Food and Drug Administration (FDA) is at odds with congressional investigators over an investigation into the federal agency’s inspection of foreign drug manufacturing facilities.
This year’s contaminated heparin scare that seriously harmed hundreds of Americans has taught us one thing – we need a better system of ensuring that drugs manufactured in foreign markets are safe for Americans.
The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants.
Will Chinese products be responsible for more deaths and hardships around the world?
Early last year, more than 80 people died and thousands more were sickened after receiving the blood thinner heparin. It was later found that specific lots had been contaminated at a manufacturing plant in China.
Five pharmaceutical companies are working on new medications to treat blood clots, also known as thrombosis, according to The Wall Street Journal. Thrombosis is a serious problem affecting nearly 900,000 Americans each year, and resulting in nearly 300,00 deaths annually. Currently, heparin and Vitamin K antagonists are the only two principal treatments for blood clots.
The U.S. Food and Drug Administration (FDA) will place more than 60 food and drug regulators worldwide over the next year to provide guidance on U.S. quality standards, according to the Associated Press. This will replace the agency’s current practice of sending staffers on individual assignments to inspect foreign facilities.
If Sen. Sherrod Brown (D-OH) has his way, we soon may be able to read the label of prescription medications and learn where they were manufactured. Sen. Brown recently introduced the Transparency in Drug Labeling Act (S. 3633), arguing that Americans have the right to know where their medications are produced, according to Pharmaceutical Technology.
