CHPA advocates restoring OTC eligibility under flexible spending accounts
WASHINGTON — The Consumer Healthcare Products Association on Friday submitted a letter to U.S. Treasury Secretary Jacob Lew, thanking the Administration for its recent efforts to enhance flexible savings arrangements’ benefits, the association announced. The association is asking the Administration to take a further step and support restoring over-the-counter medicines’ eligibility under tax-preferred accounts including FSAs and health savings accounts.
“We applaud the Administration for its efforts to revisit options that serve in the best interest of consumers meeting their healthcare needs,” Scott Melville, CHPA president and CEO said. “While the recent announcement allowing consumers to roll over as much $500 in their flexible spending arrangements is a step in the right direction, more must be done," he said. “We are calling on Congress and the Administration to lift the restrictions on consumers’ ability to use tax-preferred accounts to purchase OTC medicines that millions rely on for their healthcare needs. Reversing this restriction and restoring eligibility of OTC medicines under FSAs and HSAs is a straightforward step that will assist American families in securing affordable healthcare.”
CHPA supports the bipartisan, bicameral Restoring Access to Medication Act (S. 1647/H.R. 2835) introduced by Sens. Mary Landrieu, D-La., and Pat Roberts, R-Kan., in the Senate and Reps. Lynn Jenkins, R-Kan., and John Barrow, D-Ga., in the House of Representatives. The association’s letter urged the Administration to support this measure.
FDA approves Sasmar’s sperm-friendly lubricant
CHICAGO — The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.
Sasmar announced Friday the FDA approval of Conceive Plus, described as an isotonic, fertility-friendly personal lubricant that helps increase a woman’s chances of getting pregnant naturally. The patent-pending formula is pH balanced to mimic fertile fluids and semen and contains minerals helpful to fertilization.
The company said that other lubricants on the market have a negative effect on sperm motility and sperm chromatin integrity, which hinders the fertilization process and the chances of conception.
FDA requests label and packaging changes for certain topical antiseptic products
SILVER SPRING, Md. — The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert emailed Thursday. "We are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers," the alert stated. "The antiseptics in these single-use containers should be applied only one time to one patient. We also recommend that healthcare professionals and patients do not dilute antiseptic products after opening them. Applicators and any unused solution should be discarded after the single application."
"This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation," the agency stated. "When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, healthcare professionals and patients should follow all label directions to decrease the chances of infection."
Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease Control and Prevention. Clinical infections also have been reported to the FDA, leading to some product recalls. These infections have been confirmed to be caused by contaminated antiseptic products. Affected products included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate and quaternary ammonium products.
Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms. However, even topical antiseptics manufactured with a sterile process can become contaminated if proper care is not taken when using them, the agency noted.