FDA found bacteria in lots for recalled Tylenol Matthew Perrone, AP Business Writer, On Tuesday May 4, 2010, 6:29 pm EDT WASHINGTON (AP) -- Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last week were contaminated with bacteria, according to a report by the Food and Drug Administration. Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not definitive. "We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office, on a call with reporters. The FDA report, which was posted online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl. FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night. Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints. J&J did not investigate more than 46 complaints received in the last year about "black or dark specks" in Tylenol products, according to the FDA's report. Additionally, inspectors found some pieces of equipment covered with thick layers of dust, while others were held together with duct tape. In a statement Tuesday, J&J called the problems cited by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The health conglomerate, which is based in New Brunswick, N.J., said production at the plant won't resume until the problems have been fixed. The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives instead. J&J's McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements. FDA leadership told reporters Tuesday that they first met with J&J in February to discuss manufacturing problems identified in a warning letter about another J&J plant. The agency decided to step up inspections of the company's facilities based on those problems. "That warning letter brought us to the point where we thought it was necessary to sit down with management and discuss our concerns," Autor said. FDA officials said they are considering taking additional action against J&J, ranging from issuing more warning letters-- to pursuing criminal action.
"J&J called the problems cited by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." Unfortunately, the problems ARE indicative of how McNeil Consumer has been operating.
I worked for JNJ CHC and compared to Pfizer CHC they are a bunch of cock suckers.....no tact-no personality-just like Dave Johnson at Pfizer who was a self serving arrogant, in love with himself asshole-at least that's what everybody said-Dj the Jerk off know it all mirror man-he thrived on making people uptight-like a traffic cop with a little authority-you days coming DJ
Growth in Prescription Drug Use Continues to Slow By LINDA A. JOHNSON, AP Business WriterTuesday, April 19, 2011 TRENTON, New Jersey (AP) — Spending on prescription drugs in the U.S. grew relatively slowly last year as fewer people started new prescriptions and more prescriptions were filled with cheaper generics, an industry study shows. Americans and their insurers spent $307.4 billion on prescription drugs in 2010, up just 2.3 percent from the previous year. Growth had already slowed to 5.1 percent in 2009, from as much as 13 percent a year earlier in the decade. The study released Tuesday by the IMS Institute for Healthcare Informatics, an arm of health data firm IMS Health, shows the volume of prescription medicines that Americans used also increased at historically low levels. That's bad news for brand-name pharmaceutical companies — but may also be for doctors and patients. The number of visits to doctors' offices declined 4.2 percent in 2010, to 1.54 billion, according to the study. That downward trend began in mid-2009, as the employment rate remained stubbornly high and more people lost health insurance. Pharmacies filled 0.5 percent fewer prescriptions in 2010 than in 2009 for pills, capsules and nasal spray medications — about 60 percent of total spending on medications. For medicines that are injected or infused, total volume rose even less, just 0.2 percent. Spending on generic drugs last year's few growth areas, driven by patients with no health insurance or financial problems, insurance company lists of preferred drugs and new generic versions of a number of widely used drugs. Nearly four in five prescriptions filled last year were for generic drugs. "These trends combined to make 2010 the second-lowest sales growth period ever measured by IMS," said Michael Kleinrock, the institute's director of research development. "The lowest was 2008."
Judge orders drug company to pay SC $327 million By MEG KINNARD - Associated Press - Friday, June 3, 2011 A Johnson & Johnson subsidiary must pay South Carolina $327 million for deceptive marketing of an antipsychotic drug, a Spartanburg County judge ruled Friday. A spokeswoman for the drugmaker said the company was disappointed and would appeal. Under the order issued by Circuit Court Judge Roger Couch, Janssen Pharmaceutica Inc. — a subsidiary of the New Brunswick, N.J.-based drug manufacturer — must make the payment for violations of the South Carolina Unfair Trade Practices Act. "There is absolutely no doubt in my mind that the desire to protect market share overshadowed the good judgment of those in control at Janssen," Couch wrote. Violations of that law carry potential penalties of up to $5,000 apiece, meaning the company had faced possible consequences of more than $3.1 billion, considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone. Attorneys for the state argued in court filings that they see the number of violations as potentially including every single prescription, sample box or "Dear Doctor" letter written since the mid-1990s — numbers that reach into the millions themselves. According to his order, Couch assessed a $300 penalty per sample box of the drug that was distributed and a $4,000 penalty per publication of the "Dear Doctor" letter, for a total penalty of more than $327 million. In March, a jury said the company broke the law by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and its schizophrenia drug Risperdal and improperly claiming the drug was safer than competing medications. "Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics," Janssen vice president Ramy Mahmoud wrote in a letter dated Nov. 10, 2003. Saying that the drug manufacturer acted in good faith, attorneys for Johnson & Johnson argued it sent the "Dear Doctor" letter without being asked to do so by the U.S. Food and Drug Administration and that drug regulators never expressed any concern over the package insert. The company also made tens of thousands of drug marketing-related visits that minimized Risperdal's link to diabetes, improperly claimed the drug was safer than other competing medications and enclosed misleading information inside drug packages, a jury found. The blockbuster antipsychotic lost patent protection in 2008. Johnson & Johnson said earlier this year that Risperdal Consta, the long-acting version of the drug, generated $1.5 billion in sales last year. Spokeswoman Kara Russell said the Titusville, N.J.-based Janssen stands behind its product and the ways in which it was marketed. "The company acted responsibly and believes it did not violate the South Caroline Trade Practices Act," Russell said. South Carolina's case over Risperdal is the fourth to go to court. A Pennsylvania case was dismissed in June, and a case in West Virginia was dropped in December. Janssen has appealed a Louisiana verdict ordering the company to pay nearly $258 million for misrepresenting Risperdal's links to diabetes. In May, Johnson & Johnson mentioned in a quarterly financial filing it had set aside a reserve related to a federal criminal investigation of its sales and marketing practices for Risperdal.
