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Drug Shortages 1
Hospira has admitted that quality-control problems at a key plant will take a big bite out of third-quarter earnings. The North Carolina manufacturing facility, which turns out a big share of Hospira's injectable drugs, has slowed in the wake of FDA complaints about conditions there.
"It's quite clearly a bigger job than we thought, and we are still working through it," CEO F. Michael Ball said, adding that they are working on fixing the problems. Meanwhile, production is expected to be slower than normal at the plant through year's end.
http://online.wsj.com/article/BT-CO-20111018-710226.html
Drug Shortages 2
The problem of cancer patients being unable to get treatment because of drug shortages is resulting in many sad stories and situations. The shortage of Johnson & Johnson's Doxil illustrates just how difficult it might be to not only keep tabs on potentially scarce drugs, but also to fix the problems that cause shortages in the first place.
The center of the Doxil supply problem is a Boehringer Ingelheim unit, Ben Venue Laboratories. It has been struggling with manufacturing problems for some time and company officials have cited "capacity constraints" for their production shortfalls.
Ben Venue has recalled some drug batches due to some quality-control difficulties at a Cleveland-area plant. HealthCanada has also barred several of Ben Venue products from the country. Recently, the company has announced it will be winding down its contract manufacturing business.
A report from FDA inspectors shows the extent of Ben Venue's lapses; inspectors found metal particles in medicines, something that might have been caused by damaged metal doors at the plant; certain batches of products were contaminated by bacteria; mold was found in some manufacturing areas; equipment was rusty; and a ceiling leaked.
Ben Venue states that Doxil is a very complex drug to manufacture. Its inventory ran out because of the problems, and although J&J recently released a limited supply, a waiting list of patients remains.
http://online.wsj.com/article/BT-CO-20111017-710018.html
'Natural' Diet Pills Tainted with Sibutramine
Twenty brands of weight-loss dietary supplements have been found to contain sibutramine, a prescription drug (Meridia) pulled from the market for safety concerns. These products include names like "A-Slim 100% Natural Slimming Capsules," "P57 Hoodia," "PhentaBurn Slimming Capsules," and "Dream Body Slimming Capsules." The drug was removed from the U.S. market last October because it was linked to heart attacks and stroke.
http://vitals.msnbc.msn.com/_news/2011/10/19/8402061-natural-diet-pills-tainted-with-banned-prescription-drug
FDA Chemist Pleads Guilty to Insider Trading Linked to Drug Approvals
U.S. FDA chemist Cheng Yi Liang admitted using his access to the agency's drug-approval process to make $3.8 million in an insider-trading scheme. He faces a maximum penalty on the insider-trading charge of 20 years in prison and a $5 million fine and five years' imprisonment on the false-statements charge when he's sentenced on January 9. As part of his plea, Liang agreed to forfeit almost $3.8 million in bank and brokerage accounts and property, including his home in Gaithersburg, Maryland.
Mr. Liang exploited his position as a chemist in the FDA's Office of New Drug Quality Assessment. Now, like many others, he is facing the significant consequences of trading stocks on inside information. He profited from share purchases ahead of 19 positive announcements and on short sales before six negative decisions and avoided losses by selling stock before two other negative decisions. He averaged $135,015 on each sale.
http://www.bloomberg.com/news/2011-10-18/fda-chemist-liang-pleads-guilty-to-insider-trading-scheme.html
Jazz Pharmaceuticals Receives Another FDA Warning
The FDA released a warning letter issued to Jazz over violations at a California plant. The warning letter cites the company for failing to report 74 incidents of serious drug side effects or injuries. Companies are required to submit reports of so-called adverse events within 15 days of receiving them. The report notes that Jazz received a similar citation from the FDA in September 2007.
http://www.mercurynews.com/news/ci_19138304?nclick_check=1
Pharmacists Decry Patient-info Pact with Pfizer
Australian pharmacists are angry about a deal between the country's Pharmacy Guild and Pfizer, giving Pfizer access to patients' personal information-for a fee. Under an agreement between Pfizer and the country's Pharmacy Guild, anytime a patient fills a prescription for one of nine specific Pfizer drugs, that person's personal contact information is forwarded to the company and Pfizer pays $7 to the Guild for each record. That information is then used by Pfizer to communicate directly with patients about their medical conditions.
http://www.brisbanetimes.com.au/national/pharmacists-paid-by-drug-company-for-patient-details-20111018-1lypd.html
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