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Tres Reyes Island view of the Marinduque Mainland

Sunday, July 1, 2012

New Diet Pill in 13 Years Approved by FDA

My Co-workers during my FDA Years

The following article titled "First new diet pill in 13 years approved by FDA" was published the other day by Catholic Online (NEWS CONSORTIUM)(www.catholic.org). Having worked for FDA, this news has personal significance, reminding me of my career as an FDA Chemistry Team Leader for 12 years prior to my retirement in 2002.

"Called Belviq, the first new prescription diet pill in 13 years has won approval from the Food and Drug Administration. While the medication is intended to help roughly one-third of American adults who are considered obese, Belviq enters a pharmaceutical market where so-called "diet pills" have only enjoyed limited success. Diet pills in the U.S. have faced a long and troubled history. There have been myriad safety problems and product withdrawals, which has made the F.D.A. reluctant to approve new drugs.

Diet pills in the U.S. have faced a long and troubled history. There have been myriad safety problems and product withdrawals, which has made the F.D.A. reluctant to approve new drugs.

Chief among the many challenges facing Belviq is the fact that many diet drugs do not sell that well as insurers often do not cover them.

Will people will use Belviq? In spite of an increasingly obese U.S. population, diet drugs have not sold well in the past partially because people tend to use them for only a short time.

Developed by Arena Pharmaceuticals of San Diego, Belviq has been known as lorcaserin. The drug will be sold under the name Belviq by Eisai Inc., the American branch of the Japanese pharmaceutical company. Only one anti-obesity medicine had been approved for long-term use before Belviq's recent approval. Roche's Xenical, which reached the market in 1999 is rarely due to modest weight loss and unpleasant effects on the digestive system.

Diet pills in the U.S. have faced a long and troubled history. There have been myriad safety problems and product withdrawals, which has made the F.D.A. reluctant to approve new drugs. Belviq itself was turned down by the agency in 2010, but Arena came back with new data that assuaged the agency's safety concerns.

Doctors who treat obesity say there is a need for new medicines to help to plug a "treatment gap" between diet and exercise, which do not work for many people, and the more radical option of bariatric surgery. Obesity is a serious health condition that causes other health problems like diabetes and heart disease.

The F.D.A. is sympathetic to these concerns. "Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the drug evaluation center at the F.D.A., said in a statement.

Arena said it was not clear yet when the drug would be available to patients or how much it would cost. Because the F.D.A. deemed that there was some potential for the drug to be abused, the Drug Enforcement Administration must now decide what controls to place on prescribers, a process that Arena said could take four to six months.

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