FDA PLANS TO BOOST OVERSIGHT USING FOREIGN REGULATORS REPORTS

From this month, the FDA is sharing facility inspection data with its European counterparts. The FDA detailed its plans in documents to support generic user fee proposals. The strategy is part of a study that will improve the efficiency of inspections from 2013 - 2017.

PROPOSED RULE ON AMENDMENTS TO STERILITY TEST

Reminder that the deadline for comment on the proposed amendment is Sept 19,2011

FORMER CEO RECIEVED JAIL TIME FOR OVERSIZED TABLETS

The former CEO of KV Pharmaceutical Co., pleaded guilty to two misdemeanor violations of the Food, Drug and Cosmetic Act earlier this week. He has been sentenced to serve 30 days in jail, pay $1 million in fines and forfeit $900,000 in earnings.

The executive was charged with overseeing the sale of poorly manufactured and oversized morphine sulfate tablets, as well as other drugs, in 2007 and 2008. The sentence  follows a long list of recalls and violations by both KV Pharmaceutical  and its subsidiary, Ethex.

Production by the company in the United States was put on hold in 2009 after the FDA cited KV Pharmaceuticals for selling unadulterated and unapproved drugs, and in 2008, Ethex Corp suspended manufacturing and shipments for all products after issuing several generic drug recalls due to oversized tablets.

PFIZER RECALL PAINKLLERS DUE TO STABILITY ISSUES

Within a couple of weeks of finally acquiring King Pharmaceuticals for $3.6 billion, Pfizer has been obliged to pull sales of the recently launched opiod painkiller Embeda (morphine sulfate and naltrexone hydrochloride).

On the official web site for Embeda, King said it has voluntarily recalled from US wholesalers and retailers all dosage forms of the drug because a pre-specified stability requirement was not met during routine testing. Available data suggest that the issue is unlikely to pose a safety risk to patients using Embeda as prescribed, and the company will continue to monitor this issue.

WARNING LETTER FOR CORDIS

Johnson & Johnson (J&J) subsidiary Cordis has received an FDA warning letter for problems with testing procedures and design specifications for some of its stent products. The warning letter critisises testing procedures at the San German, Puerto Rico, plant, as certain Cypher U.S. RX stents failed a design specification test but were nonetheless released based on a release compliance test for expansion conformance. Based on the company’s Form 483 response, compliance with the design specification test is a critical parameter that must be met, according to the Feb. 16 letter.

JOHNSON & JOHNSON AGREE CONSENT DECREE

Last weeks consent decree between J&J and the FDA covers 3 facilities in the group. All the affected plants are part of the McNeil Consumer Healthcare Division. One of the plants in Puerto Rico was previously closed by J&J for an upgrade. No fines were announced with the decree. Meanwhile, another J&J subsidiary Cordis has received a Warning Letter for problems with testing procedures and design specifications for some of its stent products. THe woes continue as the CEO of DePuy exits as the company faces numerous lawsuits, recalls and an FDA investigation.

GERMAN FACILITY RECEIVES WARNING LETTER

Sanofi Aventis aseptic manufacturing facility in Frankfurt receives a warning letter from the FDA. The September 2010 inspection of the facility, following a recall earlier in 2010, identified shortcomings with sterility testing, airflow monitoring, environmental monitoring and training. The company's responses in Oct 2010 and Jan 2011 failed to allay concerns resulting in this months warning letter. The letter can be read here.

FDA PUBLISH LONG AWAITED UPDATE TO VALIDATION GUIDANCE.

The FDA Guidance on Process Validation, first published in 1987, has been finalised. the final version differs little from the draft update published in 2008. In the new version. there is an increased emphasis on the risk based approach; process improvement is emphasised; there is clarification of definitions in this area and a number of ASTM Guides are references. The final version is available here.

FDA JOINS PIC/S

FDA is now a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/s) as of 01 Jan 2011.