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.
House committee to hold hearing over J&J recall
WASHINGTON House Committee on Oversight and Government Reform chairman Ed Towns, D-N.Y., on Thursday announced that the committee will hold a hearing Sept. 30 at 10 a.m. to examine the circumstances surrounding Johnson & Johnson’s recall of more than 135 million bottles of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare, including children’s Tylenol, infant’s Tylenol, children’s Motrin and children’s Benadryl.
The hearing also will examine the circumstances surrounding a “phantom recall” of a particular Motrin product, which became public as a result of the committee’s hearing on May 27.
“This is about the safety of trusted medication that our children and grandchildren use,” Towns stated. “The evidence we have uncovered since our first hearing is extremely troubling.”
Witnesses invited to testify include Bill Weldon, J&J chairman and CEO, and Colleen Goggins, J&J worldwide chairman, consumer group.
The hearing will be webcast on the committee’s website, Oversight.house.gov.
Forest Pharmaceuticals pays $313 million in settlement deal
SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.
The FDA said Wednesday that Forest Pharmaceuticals, a subsidiary of New York-based Forest Labs, had entered a plea agreement whereby it would accept criminal responsibility for distribution of an unapproved drug, distribution of a misbranded drug and obstruction of an FDA inspection. The total payment of $313 million includes $164 million in criminal penalties.
One charge centered around the marketing of Levothroid (levothyroxine sodium), an unapproved drug used to treat hypothyroidism. A 1997 Federal Register notice announced that Levothroid is a “new drug,” and that manufacturers who wish to continue marketing it would have to obtain approval from the FDA by August 2000.
The company also is charged with alleged off-label promotion of the antidepressant Celexa (citalopram) for use in children; the drug is only approved for use in adults. The charge of obstructing an FDA inspection relates to an alleged 2003 incident in which Forest employees made false statements to the agency.
“We are pleased to bring closure to this long-running investigation,” Forest chairman and CEO Howard Solomon said. “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations and that our employees uphold the highest principles of integrity, honesty and ethics.”