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  • Age Restriction Removed on OTC Morning After Pill

    Posted on April 5, 2013 by in Heath Care News, News

    A federal judge has reversed an HHS decision that restricted over-the-counter access to the levonorgestrel-containing emergency contraceptives Plan B and Plan B One-Step (morning after pill) to women and girls 17 and older.

    In his ruling, Judge Edward Korman of the U.S. District Court’s Eastern District of N.Y. cited political pressure as a reason for the 2011 decision by Department of Health and Human Services secretary Kathleen Sebeliusthat prevented the FDA from expanding over-the-counter access to the pills without age restrictions, as the agency had planned.

    “Secretary Sebelius’s directive to the FDA … forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability,” Korman wrote in his opinion yesterday.

    He ordered the FDA to “make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days.”

    Nancy Northup, president and CEO of the Center for Reproductive Rights, one of the plaintiffs in the court case, said the ruling “has swept away all the FDA’s stalling, all the interfering, and all the political gamesmanship.”

    The message is clear, she said on a conference call with reporters: “Women’s reproductive health and access to reproductive healthcare must never be held hostage by politics.”

    Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and older while maintaining the prescription requirement for younger females in 2006. That decision followed a denial of a Citizen Petition from reproductive-rights groups seeking over-the-counter access for all age groups.

    In 2009, Korman ruled that the FDA must make the pill available without a prescription for 17-year-olds as well, concluding that the FDA’s denial of the Citizen Petition was “arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making.”

    Korman agreed that “the FDA bowed to political pressure emanating from the White House and departed from agency policy.” He did not remove all age restrictions at that time, deciding instead to leave the decision to the FDA, which had come under new leadership after President Barack Obama was elected.

    The single-pill version of the drug — Plan B One-Step — was approved later that year and was subject to the same age restrictions.

    The manufacturer — Teva Women’s Health — then submitted a supplemental new drug application seeking to allow over-the-counter access to girls and women of all ages.

    The FDA initially approved the application, and commissioner Margaret Hamburg, MD, explained that the agency “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.”

    Sebelius disagreed with the decision, however, and ordered the FDA to deny that application, stating “that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.” President Obama supported the decision.

    Korman reversed that decision yesterday, but left open the possibility of further action from the FDA.

    “On remand, the FDA may determine whether any new labeling is reasonably necessary,” he wrote. “Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product.”

    The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Society of Adolescent Health and Medicine, and Planned Parenthood all came out in support of the judge’s ruling.

    Click for Original Article

     


    MinuteMed Walk In Clinic- Walk In Clinic Lafayette LA

    If you’re looking for high quality, personal service you’ve come to the right place. At MinuteMed Walk-In Medical Clinic (Lafayette Walk In Clinic) & Urgent Care in Lafayette, Louisiana, we’ll give you the attention and personal service you’ll come to expect and enjoy. Walk-Ins are welcome or you can go to our “Contact Us” page and give us a call to schedule an appointment!

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    Lafayette Medical Services from MinuteMed Walk in Clinic & Urgent Care Facility is designed to provide affordable and timely minor medical and primary care to individuals in our community. Our Acadiana Walk In Clinic will offer services of experienced and friendly physicians and nurse practitioners to provide patients with thorough assessments, diagnosis, and treatment of minor ailments, as well as screening, preventative medicine, and health education.

    Our services include but are not limited to:

    • Minor illnesses such as Respiratory Illnesses, Eye, Ear, and Nasal Infections, etc.
    • Minor Injuries such as Muscle Strains, Wounds, Burns, Bites, etc.
    • Skin conditions such as Lice, Rashes, Fungal Infections,
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    • Laboratory Test and Blood Work Interpretation
    • Flu, Tetanus, and TB Vaccinations
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    • Wart, Skin Tag, and Mole removal, Abscess Drainage, and Laceration Repair
    • Joint Injections
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    • Botox Injections – Headaches, Excessive Underarm Sweating, and Wrinkles
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    MinuteMed Walk In Clinic Accepts All Private Insurances if not currently Enrolled we will attempt to include your insurance Company and charge you at the Insurance company rate.

    MinuteMed Walk In Clinic does not accept Medicare or Medicaid

    We Proudly Accept BE (Business Express)

     MinuteMed Walk In Clinic & Urgent Care Lafayette LA


    No Insurance? High Deductible?

    Have you heard of ProMedX?

    WHAT IS PROMEDX?

    ProMedX is a state-certified healthcare membership policy which allows policy holders to receive minor medical care at a discounted rate.

    Who Can Sign Up For ProMedX?

    Those without any healthcare coverage. Those who only have major catastrophic or high deductible policies. Small business owners as part of a benefits package. Business owners looking for a less expensive option for minor medical care for their full-time or part-time employees. Business who are self-insured.

    What do I Get If I Join?

    Policy Holders pay only $20 per office visit. Your policy benefits include The office visit.  Treatment of your minor illness and injuries including but not limited to – allergy symptoms, coughs, flu-like symptoms, pink eye & styes, sore throat, urinary tract infection, skin conditions, cuts & lacerations, sprains & strains. Any required in-house lab work (US, UPT, rapid strep test, blood sugar, flu test, urine drug screen). Discounts on in-house prescription medications. Annual influenza vaccine (no office visit charge). Annual physicals for work or school and Much More.

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    Individual policies cost is a reasonable $50.00 per month per yearly contract effective the next business day. $20.00 exam fee per visit. $200.00 per month for a family of 4 or more. Optional $120.00 per member sign up fee. ($100.00 activation fee plus $20.00 exam fee. Allows policy to take effect same day and covers full price of your visit). May cancel the policy at any time after six months with written notice. You will not be denied a policy due to previously existing conditions.

    Want more information about ProMedX?

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    Need more information?  You can download the ProMedX Healthcare Policy Contract or you can call Mark at (337) 280-7459 or Amanda at (337) 257-6525 or click here for the ProMedX Website.

    ProMedX Certified Minor Healthcare Policy Lafayette LA

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