FDA should consult advisory committees on DXM issue
WHAT IT MEANS AND WHY IT’S IMPORTANT While the advisory committee vote of 15 opposed and nine in favor of scheduling the all-too-common cough-relieving ingredient dextromethorphan as a controlled substance might seem like a healthy indicator as to which direction the Food and Drug Administration will act on this issue, make no mistake: it is by no means a certainty. This still may be an issue for cough-cold season 2011-2012.
(THE NEWS: FDA advisory committees forgo restricting cough-cold sales, CHPA responds. For the full story, click here)
But here are more than a few reasons why the FDA should act in concert with its advisory committees on this issue.
Restricting access to a cough-relieving ingredient as prevalent as DXM would increase healthcare costs, those opposed to scheduling the ingredient have argued. That’s because consumers in search of cough-cold relief now would need to schedule and pay for a doctor’s appointment. Such a wholesale change in the access to common cough-cold ingredients also very well may impede labor productivity as well, because those consumers who schedule that doctor’s appointment likely will miss work, and those consumers who decide to just suffer through their illness likely will be less productive at work.
More important, scheduling DXM may not accomplish its stated objective, whether that’s reducing teenage access to DXM or reducing the number of teenagers who potentially would abuse DXM. That’s because teenagers aren’t necessarily acquiring their DXM “fix” from retailers — they more easily can acquire DXM from online resources or by sifting through their parents’ medicine cabinets. And retail pharmacy already has procedures and programs in place to reduce either access or incidence. It’s something, as a group, that they’ve been doing for years.
Retailers, for example, enforce an age restriction on the sale of DXM — not selling products to minors under the age of 18 years. And the National Association of Chain Drug Stores recently testified that retail pharmacy would fully support codifying this age restriction, an approach that last year had been submitted to Congress by Sen. Dick Durbin, D-Ill.
Similarly, both NACDS and the Consumer Healthcare Products Association supported legislation that would restrict the sale of bulk dextromethorphan to any entity not registered with the FDA. That’s a law that significantly would inhibit any Internet sales of DXM products to minors.
The CHPA also aggressively has been raising awareness among parents and other concerned groups — teachers for example — about the abuse potential of any medicines that can be found in that medicine cabinet, not just DXM. The CHPA’s attention to this issue is nothing new — the organization actively has been addressing this concern with such partners as the Partnership for a Drug-Free America since 2003.
Last year, all of the industry’s efforts to raise awareness around the teenage abuse of medicines were combined into one comprehensive website: StopMedicineAbuse.org. The site is a portal that affords easy access to all the industry’s initiatives and interactive programs that engage parents and community leaders in the fight against teen cough-medicine abuse.
MDA offers vouchers for free flu shots at Walgreens
SALT LAKE CITY Walgreens is teaming up with the Muscular Dystrophy Association to administer flu shots to those who need them most, according to published reports.
The MDA is handing out vouchers for free flu shots at Walgreens to those affected by muscular dystrophy and related diseases, according to ABC4News in Salt Lake City.
Voucher requests can be submitted here.
CBO: Generics saved $33 billion for Medicare Part D in 2007
WASHINGTON Generic drugs saved Medicare Part D beneficiaries and the program as a whole $33 billion in 2007, according to a new report by the nonpartisan Congressional Budget Office. The CBO expected another $14 billion in annual savings to accrue as many new generics enter the market through 2012.
The main lobby for pharmacy benefit managers said the report also showed the advantages of pharmacy benefit managers.
“Tools pioneered by pharmacy benefit managers — including encouraging the use of generic medications — have lowered costs and expanded access to prescription drugs for seniors in Medicare Part D,” Pharmaceutical Care Management Association president and CEO Mark Merritt said.
The generic drug industry lobby hailed the report as well. “This new CBO study is just one of a continued body of evidence proving that generics are a key cost-saving component of our healthcare system,” a statement by the Generic Pharmaceutical Association read.
According to the market research firm IMS Health, generic drugs accounted for nearly 75% of prescriptions dispensed in the United States, but for just more than 19% of dollars spent.