HEALTH

GSK Consumer Healthcare to FDA: Smoke out smokeless tobacco products

BY Allison Cerra

PARSIPPANY, N.J. GlaxoSmithKline Consumer Healthcare is urging the Food and Drug Administration to remove smokeless tobacco products from the market.

GSK Consumer Healthcare, which manufactures such nicotine-replacement therapy products as Nicorette and NicoDerm CQ, submitted a comment to the FDA on the potential public health impact of oral dissolvable tobacco products, "calling for such products to be withdrawn from the market until their sponsors can demonstrate to [the FDA] that their marketing is appropriate for the protection of public health," the company noted in a release Tuesday.

The announcement comes after the American Heart Association issued a policy statement on smokeless tobacco products, which said that such products are not safe alternatives to smoking and are associated with heart attack, stroke and certain cancers.

GSK Consumer Healthcare also said that it is committed to working with the FDA, in addition to medical and clinical experts to make smoking-cessation products safe and available for consumers.

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In testimony, NACDS hails federal effort to simplify patient medication information

BY Jim Frederick

ROCKVILLE, Md. Federal efforts to simplify and standardize the information that patients receive with their prescription medications are laudable and should continue, the chain pharmacy lobby told Obama administration health officials Monday.

That message to the Food and Drug Administration came from the National Association of Chain Drug Stores, which has pushed for simpler patient package inserts, and on a more basic level, a single standard for conveying patient medication information. In a presentation to an FDA public hearing, NACDS VP government affairs and pharmacy adviser Kevin Nicholson said his group is “very pleased” that the agency appears to be moving toward a single information document with standardized format and content. He urged federal health officials to “continue to move toward this laudable goal with all reasonable haste.”

Under current FDA rules, Nicholson testified, “Patients receive several different types of information, developed by different sources that may be duplicative, incomplete, or difficult to read or understand.” The agency should work with NACDS, other pharmacy groups, manufacturers and patients themselves, he asserted, to come up with a “one document solution” to the knotty issue of PMI.

“Patients want a useful document, designed and written for them, that recognizes their information needs, that focuses concisely on critical information and that provides them with clear instructions on where to go for further advice and instruction,” Nicholson told the FDA panel. What’s more, he said, “The provision of multiple documents, containing redundant or even conflicting information, creates logistical and financial burdens for pharmacies that compromise effective patient counseling. It would be far more convenient, efficient and ultimately more effective for pharmacists to counsel patients by providing a single document that could easily be understood and facilitate a discussion concerning proper use of medication.”

That said, the NACDS executive noted, “our first recommendation is for FDA approval of all PMI. However, considering that FDA approval may not be feasible, we urge the agency to develop pilot programs to test various modes of ensuring standard content and format, including using simplified and modified PPIs as PMI. Any pilot program should also test different modes of patient access and delivery to the patient at the pharmacy, at the point of prescribing and via the Internet and/or electronic health records,” Nicholson concluded. “The key to success for PMI will be for continued collaboration among the agency, manufacturers, pharmacies, prescribers and consumer groups.”

In mid-2008, NACDS and seven other pharmacy and consumer organizations submitted a citizen petition to urge the FDA to move to “a concise, plain-language document for patients that would consolidate and replace the multiple written communications pharmacies currently are required to distribute to patients.” Adopting a standard, easier-to-understand medication information format, Nicholson told the agency, would help boost patient adherence, improve health outcomes and cut needless healthcare expenditures.

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Decoding Health Reform 2.0

BY Rob Eder

As I write this column, it’s the final Super Tuesday primaries in eight states, including here in New York, before the big mid-term elections in November. And if the Sunday morning news shows are right, the Democrats are in for a spanking. Given the present state of the economy, the stagnant job market and the American electorate’s need to find someone to blame, it’s really kind of inevitable.

Certainly, health reform hasn’t proven to be the societal glue keeping the country together that many in Washington had hoped it might be. More and more the polls indicate that Americans are unsure of what ObamaCare really means for them—whether it means less or more for people who already have health care. An August Kaiser Health survey found that 43% of Americans still had a favorable view of the health-reform act; 45% had an unfavorable view.

I have been fairly certain that the Patient Protection and Affordable Care Act of 2010 would morph and evolve into something quite different from its present form long before we have reached the official implementation date in 2014. While HHS, CMS, the GAO and every other fancy acronym that interprets the laws Congress writes and the President signs figures out how to take the massive piece of legislation from words to action over the next few years, the shift in power this November will feed something I have called Health Reform 2.0.

To be sure, it will be called something else, something MUCH longer by the time it becomes law. And while I can’t predict everything the new version will contain, I am certain it will favor the use of more private sector-driven solutions—like retail clinics.

The introduction of a Senate resolution in late July designating the first week of August as National Convenient Care Clinic Week is a good sign that the ladies and gentlemen on the Hill are aware of the important role clinics will play in the future.

I also believe that Health Reform 2.0 will reintroduce eligibility for tax deductions for over-the-counter purchases under flexible spending accounts. Why? Because eliminating OTC eligibility from FSA plans stands in diametric opposition to the overarching spirit of health reform.

Under the old rules, depending upon what tax bracket you were in, you could save anywhere from 15% to 20% on every healthcare dollar spent by allocating a certain amount of pre-tax dollars to an FSA each year—including most OTC remedies. Under ObamaCare, OTC eligibility has been scrubbed from FSA plans to help pay for the total cost of the plan.

But eliminating OTC eligibility from FSA plans will drive up total out-of-pocket costs for millions of Americans who have come to rely on the exemption to make health care more affordable. According to the Bureau of Labor Statistics, as of March 2007, 33% of American workers who worked for companies with 10 or more employees participated in FSA programs.

This is precisely the kind of thing Americans don’t like about ObamaCare. But it is a relatively easy thing to undo.

In 2003, the Republicans took the Clinton White House’s vision for universal health care and turned it into the Medicare Modernization Act of 2003, creating the Part D drug benefit. It isn’t perfect, but it is an example of a market-based solution that has helped make the cost of healthcare more manageable for the average senior.

Maybe that’s the new definition of bipartisanship: the Democrats made health reform an issue; now it’s up to the Republicans to figure out how to pay for it.

Either way, I believe Health Reform 2.0 will favor more private-sector solutions that incentivize consumers to make smarter, more cost-efficient healthcare purchasing decisions that save real dollars for patients and payers. Kind of the way it worked when you could use tax-free dollars to pay for your OTC purchases if you were on an FSA plan.

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