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,
http://www.gphaonline.org/) 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 (
http://www.sanofi-aventis.com/) 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
The site is expected to close by the end of the year, with the loss of about 200 jobs.
FDA Inspections and Warning Letters Continue to Decline
Rockville, MD (Mar. 1)—The number of US Food and Drug Administration (
http://www.fda.gov/) 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
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.