May 2007 - Pharmaceutical Technology

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May 2007

Pharmaceutical Technology

Loew goes on to state that clinical trials are necessary to prove the safety and effectiveness of follow-on biologics. Current legislative proposals regarding follow-on biologics do not call for clinical trials.

Meanwhile, Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association (GPhA, released a statement emphasizing Woodcock's statement that FDA "has the scientific expertise to review" generic biologics and the "same scientific principles that apply to the review of changes made to brand products after approval would also be underpinning the review of biogenerics."

"[The] hearing also proved that the claim by PhRMA and BIO that the legislation will restrict FDA's ability to require testing is simply false," said Jaeger, claiming the organizations are "playing the scare-tactics card."

-Maribel Rios, Brianne Harrison


Sanofi to Close Irish Plant

Paris (Mar. 15)—Sanofi-Aventis ( plans to close its manufacturing site in Waterford, Ireland.

The company attributes the closure to increasing pressure from generics. Sanofi came to the decision after evaluating its plant network and concluding that other sites had excess capacity and could take over the manufacturing currently performed at the Waterford site with minimal extra investment.

The Waterford plant currently manufactures mature and over-the-counter products, including "Essentiale" for liver protection and "Flagyl" for microbial infections. Manufacture of these two products will be taken over by Sanofi plants in France and Germany.

The site is expected to close by the end of the year, with the loss of about 200 jobs.

-Brianne Harrison


FDA Inspections and Warning Letters Continue to Decline

Rockville, MD (Mar. 1)—The number of US Food and Drug Administration ( inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs. This total has decreased since 2002, when the agency reported 4570 inspections.

The report states that the Center for Drug Evaluation and Research (CDER) conducted 2411 domestic and foreign inspections in 2006, compared with 2682 in 2005. The number of CDER inspections is at its lowest point since 2002, when the center reported 2585 inspections.

The Center for Biologics Evaluation and Research (CBER) also conducted fewer inspections in 2006. The center reported 1826 domestic and foreign inspections in 2006, a decline from the 1931 inspections during 2005. CBER's inspections have decreased since 2003, when the center's annual total was 2205.

In contrast, both CDER and CBER issued more Class I recalls in 2006 than in 2005.

A recall is an action taken by a firm either to remove a product from the market or to conduct a field correction. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death, according to FDA.

CDER's total of 45 Class I recalls in 2006 is the greatest number of the past five years and an increase from the 18 such recalls in 2005. CBER issued 13 Class I recalls in 2006, compared with a single such recall in 2005. In 2006, CBER issued more Class I recalls than in 2005 and 2004, but fewer than its recent peak of 24 in 2003.


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