HEALTH

Report: Teva seeks approval to market Plan B One-Step for females under 17 years

BY Michael Johnsen

NORTH WALES, Pa. — Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

The switch of Plan B from prescription-only to a de facto behind-the-counter status marked a tumultuous debate for the FDA under the Bush administration. Consequently, many advocates are gearing for another political battle. Many women’s groups seek wider access, while conservative groups would like to greatly limit access altogether because they believe Plan B is an abortion alternative.

According to reports, Teva gave the FDA additional data based on a study of actual use of the contraceptive in girls between the ages of 11 years and 16 years. It expects the agency to rule within 10 months.

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NACDS expresses support of The Patients’ Freedom to Choose Act of 2011

BY Antoinette Alexander

ALEXANDRIA, Va. — Companion legislation, which seeks to change a provision in the healthcare-reform law and permit Americans to use their flexible spending accounts and health savings accounts to buy over-the-counter medications without a prescription, has the support of the National Association of Chain Drug Stores.

Known as The Patients’ Freedom to Choose Act of 2011 — introduced by Rep. Erik Paulsen, R-Minn., and Sen. Kay Bailey Hutchison, R-Texas — the bill seeks to change a provision in the healthcare-reform law, the Patient Protection and Affordable Care Act, and permit Americans to use their FSAs and HSAs to purchase OTC medications without a prescription.

Currently under the law, patients first must receive a prescription for an OTC medication before they can be reimbursed from their pre-taxed FSA or HSA.

"By restoring consumers’ ability to use FSAs and HSAs for [OTC] products, these bills will help ensure that Americans can continue to conveniently utilize their local pharmacies for cost-saving OTCs," stated NACDS president and CEO Steve Anderson.

"An estimated 35 million working Americans rely on voluntary contributions of pre-tax dollars to FSAs to help meet their basic healthcare needs," Anderson added. "Prohibiting the use of FSA funds to purchase these medicines, or requiring a prescription or other documentation from a doctor, limits access and eliminates the cost efficiencies associated with these medicines."

In an incremental victory for NACDS and for allied voices on this issue, the Internal Revenue Service in late December 2010 announced that FSA debit cards would be allowed to be used for OTC medications for which patients have a prescription. Previously, the IRS had indicated that such debit cards would not be permitted for use in purchasing medication affected by the new policy, even if a consumer had obtained a prescription for the medications. The legislation introduced by Sen. Hutchison and Rep. Paulsen, however, would provide a more comprehensive remedy to this issue, the NACDS stated.

"We appreciate the leadership and commitment of Rep. Paulsen and Sen. Hutchison in introducing their companion bills," Anderson stated.

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FDA reconsiders safety of OSP use for bowel cleansing as an OTC indication

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.

A request for public comments will be published in Friday’s Federal Register.

“[The] FDA is issuing this proposed rule after a careful review of new data and information on the serious side effects that have been associated with the customary dose of OTC sodium phosphates solution … for bowel cleansing prior to colonoscopy,” the agency stated.

The FDA initially raised safety concerns in 2008, after which Fleet Labs, which fielded an OTC product containing a sodium phosphate solution, voluntarily recalled that product (Fleet Phospho-soda).

Oral sodium phosphate products often are recommended by physicians for bowel cleansing prior to a colonoscopy or other medical procedure.

The safety issues raised by the prescription and professional use of OSP for bowel cleansing has led the FDA to reconsider the appropriateness of bowel cleansing as an OTC indication. However, the agency planned to address the status of bowel cleansing as an OTC indication in a future Federal Register publication.

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