FDA advisory committees forgo restricting cough-cold sales, CHPA responds
WASHINGTON A pair of Food and Drug Administration advisory committees on Tuesday evening recommended that the FDA not place greater sales restrictions on the sale of dextromethorphan by placing the ingredient on the controlled substances schedule. The panel of FDA advisers voted to not schedule DXM by a vote of 15-9.
"Today’s FDA advisory committee decision not to recommend scheduling [over-the-counter] cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan,” the Consumer Healthcare Products Association stated in a release following the decision. “Because of cough’s widespread prevalence and effects, it’s vital for people to have OTC access to safe and effective self-treatment. Dextromethorphan is in nearly 90% of OTC cough suppressants sold today,” the statement read.
"We do, however, recognize the need for continued education to keep any abuse levels low,” the CHPA added. “We also have long called for federal legislation that would limit purchases of bulk quantities of dextromethorphan to manufacturers who are registered with FDA. We believe that a statutory ban on sales of dextromethorphan medicines to those under 18 [years of age] would limit abuse.”
IRS’ updated FSA rules regarding OTC medicines draw response
WASHINGTON The Internal Revenue Service earlier this month issued guidance reflecting statutory changes regarding the use of certain tax-favored arrangements, such as flexible spending arrangements, to pay for over-the-counter medicines and drugs.
The Affordable Care Act, enacted in March, established a new uniform standard that, effective Jan. 1, 2011, applies to FSAs and health reimbursement arrangements. Under the new standard, the cost of an OTC medicine or drug cannot be reimbursed from the account unless a prescription is obtained. The change does not affect insulin, even if purchased without a prescription, or such other healthcare expenses as medical devices, eye glasses, contact lenses, co-pays and deductibles, the agency stated. The new standard applies only to purchases made on or after Jan. 1, 2011, so claims for medicines or drugs purchased without a prescription in 2010 still can be reimbursed in 2011 if allowed by the employer’s plan.
WageWorks, a provider of consumer-directed benefits solutions, including FSAs, this past summer advocated an extension of that Jan. 1 deadline, arguing that all parties — consumers, retailers and third-party administrators — needed additional time to react to the changes. “This restriction will hurt millions of consumers who rely on their FSAs to manage their out-of-pocket healthcare costs and pay for necessary over-the-counter therapies,” stated Joe Jackson, CEO of WageWorks. “If Congress is intent on putting this provision into effect, they should at least push back the deadline so that consumers — and especially retailers — are ready for the transition.”
Jody Dietel, president and chair of the Special Interest Group for Inventory Information Approval System Standard said, “Without clarification on the type of permission needed for FSA reimbursement for OTC drugs, consumers, retailers and third-party administrators will be confused and unlikely to fully comply with the new regulations by the start of new year. Meanwhile, we’re likely to see doctor’s offices overwhelmed with patients seeking prescriptions to use their spending accounts for Claritin, Zyrtec and other OTC items,” she said. “A delay in implementation will provide time for all parties to be better educated on the issue and prepared to comply with the new rules.”
SGIS maintains an electronic list of FSA-eligible products used by most retailers in the country.
The new regulations, even the recent guidance issued by the IRS, leave many questions unanswered, according to a report on The Bulletin published last week. Will physician prescriptions be required to specify a number of pills with the prescription, or can consumers buy bulk-sized containers of pain relievers? And if pharmacies must process prescriptions for aspirin or cold medication, will they seek some dispensing fee for their time?
“We’re concerned that there will be a lot of confusion out there,” Jeff Beadle, CEO of SIGIS, told The Bulletin. “Someone is buying Tylenol in December, and they can’t now buy Tylenol in January unless they go to their doctor and get a prescription first.”
The report suggested retailers will face an additional challenge — when to update the list of eligible products under FSA plans because many FSA plans do not run on a calendar year.
RC2’s The First Years brand inks deal with Natus Medical
OAK BROOK, Ill. A brand made by RC2 has inked a product licensing agreement with a leading provider of healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical ailments in newborn care.
As part of the deal, Natus Medical will manufacture and distribute a line of The First Years brand’s GumDrop pacifiers, accessories and other related items. The First Years’ GumDrop product line is slated to debut at retail in early 2011.
GumDrop pacifiers are available in two sizes, newborn (0 to 3 months) and infant, and come in playful green, blue, orange, pink and purple colors. In addition to pacifiers, The First Years’ GumDrop line will include pacifier clips and cases.