HEALTH

Mead Johnson Nutrition elevates three executives

BY Michael Johnsen

GLENVIEW, Ill. — Mead Johnson Nutrition Wednesday evening announced a number of management changes under Mead Johnson president and CEO Steve Golsby.

“Given the growing size and complexity of our global operations, I recognized the need to refine our management structure in order to drive superior performance and operationalize our ambitious strategic plan,” Golsby said.

Kasper Jakobsen, currently the company’s president Americas, will assume the newly created position of EVP and COO effective Jan. 1. Jakobsen will head up the company’s global operating committee and lead all regional business activities, as well as global marketing and global supply chain, with overall responsibility for driving the company’s operational performance.

Charles Urbain, 57, will assume the new role of SVP stakeholder relations and chief development officer, with overall responsibility for the company’s business development activities and external relations, including external affairs, corporate communications and corporate social responsibility. Additionally, Pete Leemputte, 54, has been named EVP and CFO in recognition of his contributions to the business and his leadership responsibilities across the company’s finance, tax, treasury, investor relations, information technology and audit functions.

Jakobsen, 49, has been leading Mead Johnson’s businesses across North America and Latin America since January 2009. He joined the company in 1998 and advanced through several positions of increasing regional responsibility, including general manager in the Philippines and Pacific Islands and VP and general manager for South Asia. From 2006 through 2008, he served as SVP Asia-Pacific.

Prior to joining Mead Johnson, Jakobsen worked for nearly a decade at Unilever in various marketing roles. Born and raised in Denmark, he holds a bachelor’s degree in commerce from Auckland University in New Zealand.

Urbain joined Mead Johnson in 1996 and has led each of the company’s regional businesses, as well as the finance function. Since 2009, he has served as president Asia & Europe.

Each of the executives will continue to report directly to Golsby.

 


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FDA, parent agency HHS divided over emergency contraceptive prescription status

BY Michael Johnsen

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

"This morning I received a memorandum from the secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential," Hamburg stated. "Because of her disagreement with the FDA’s determination, the secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved."

Plan B One-Step will remain on the market with its dual prescription/nonprescription status — available from behind the pharmacy counter to women over the age of 17 years and by prescription only for women younger than 17 years.

Following a review of consumer usage studies, FDA’s Center for Drug Evaluation and Research determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

"It is our responsibility at the FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence," Hamburg stated. "CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential."

"I have carefully considered FDA’s Division Director Summary Review of Regulatory Action, dated Nov. 30 2011, for the supplement application, which represents the position of the FDA and recommended approval of the application," HHS secretary Kathleen Sebelius wrote in a letter addressed to Hamburg. "Based on my view, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages."


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HHS instructs FDA to decline proposal to move Plan B from BTC to OTC

BY Michael Johnsen

WASHINGTON — The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B. Presently, Plan B can be sold without a prescription to women older than 17 years old but only in a pharmacy and from behind the pharmacy counter. Women younger than 17 years require a prescription to acquire Plan B.

"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed [the Food and Drug Administration] to issue a complete response letter denying the supplemental new drug application by Teva Women’s Health," stated HHS secretary Kathleen Sebelius.

"This application sought to make Plan B One-Step available over the counter for all girls of reproductive age," she stated. "The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."

The average age of the onset of menstruation for girls in the United States is 12.4 years, Sebelius noted. However, about 10% of girls are physically capable of bearing children by 11.1 years of age. "It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age." 


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