HEALTH

Medical community decries decision to maintain status quo of emergency contraceptive

BY Michael Johnsen

WASHINGTON — A group of medical associations on Wednesday denounced the government’s decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.

“As advocates for the health and well-being of all young people, the [American Academy of Pediatrics] recommends that adolescents postpone sexual activity until they are fully ready for the emotional, physical and financial consequences of sex,” stated Robert Block, AAP president. “However, as physicians who care for our nation’s children, it is our responsibility to protect the health of our teenage patients, and an unintended pregnancy can have significant implications for adolescents’ physical and emotional health.”

Plan B has long been an industry hot button, even before Barr Pharmaceuticals’ subsidiary Duramed first started shipping the first and only dual-status nonprescription/prescription drug in November 2006. Plan B was to be sold from behind the pharmacy counter without a prescription to women 18 and older; and dispensed to women younger than 18 so long as they had a valid prescription. Before gaining that dual status, Plan B was a de facto behind-the-counter medicine in nine states, where pharmacists were allowed to dispense a Plan B course without a prescription under certain circumstances.

Former FDA commissioner Lester Crawford was the commissioner who delayed the FDA decision to approve the prescription-to-OTC switch of Plan B — based on a reluctance to create a dual status class of medicines, according to Crawford. Crawford resigned abruptly in 2005 (for reasons unrelated to Plan B), and the Congressional approval of his proposed successor, Andrew von Eschenbach, was delayed until FDA in essence promised to approve the switch application for the emergency contraceptive.

The medicine was controversial even among pharmacists, many of whom were implored by their peers to practice a refuse-and-refer policy, whereby a pharmacist who was not comfortable adjudicating a Plan B request would be able to refuse the prescription and refer that prescription to a pharmacist who would fill it, even if that meant sending the patient to another pharmacy.

The group of medical associations on Wednesday was particularly concerned that the U.S. Department of Health and Human Services overruled what would have been an approved sale of Plan B with no prescription restrictions by the Food and Drug Administration. “The decision to continue restricting access to this safe and effective product is medically inexplicable,” Block said. “The AAP strongly encourages the use of contraception — including [emergency contraception] by adolescents who choose sexual activity, and recommends that teens receive appropriate counseling on EC use by a pediatrician or other primary care physician.”

The group of medical associations included the AAP, the American College of Obstetricians and Gynecologists (The College) and the Society of Adolescent Health and Medicine. The AAP and SAHM recommend that adolescents be counseled on emergency contraception in the context of a discussion on sexual safety and family planning, regardless of current intentions for sexual behavior. All contraceptive counseling for adolescents should include information on the use and availability of emergency contraception wherever these visits occur, including emergency departments, clinics and hospitals, the associations added.

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H.ZANDIO says:
Dec-12-2011 12:53 am

A lot of young people are involved in premarital sex. At this age, they are not yet ready financially and emotionally. Most of them use contraceptives to avoid pregnancy. The morning after product is accessible without a prescription. However, the pill is only accessible behind a pharmacy counter, with ID. Regardless of an FDA advice that the drug be moved from behind the pharmacy counter and be more widely accessible, it will still be purely limited. These restrictions may make it more difficult to get then before. http://www.newsytype.com/13889-plan-b/

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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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