GSK withdraws regulatory application for additional use of Avodart
LONDON British drug maker GlaxoSmithKline is temporarily withdrawing its regulatory approval application seeking an additional use for an enlarged prostate treatment in order to update it, the company announced Monday.
The company is seeking approval from the Food and Drug Administration of Avodart (dutasteride) for prostate cancer risk reduction in men who have increased risk of developing the disease. The drug is currently approved for treating enlarged prostate.
GSK did not specify what it would add to the application, but said the updates were not related to new safety or efficacy findings and that it would resubmit the application “shortly.”
NADDI cracks down on methamphetamine with new initiative
NEW YORK In a nutshell, this program gives any legislative body — state or local — debating around whether a prescription ought to be required in the purchase of a pseudoephedrine product one less reason to pull the trigger on that decision. And it’s a pretty big reason. Before, the argument could be made that implementing a program like NPLEx was prohibitive because of the associated cost.
That’s a sound argument even if it means making PSE prescription-only for all the wrong reasons. And that’s true especially in today’s economy, where state and local governments both are doing their level best to continue providing community-wide services despite dwindling coffers.
But now the money argument shifts in the other direction, because now there are no costs associated with programs like NPLEx for state or local governments, except maybe in prosecuting and housing criminals. And that’s a cost that should pay dividends going forward, because they’ll actually be purging a lot of these methamphetamine-addicted criminals from mainstream society.
The fact is, that’s potentially the best benefit from this program, pulling those criminals off the streets. Requiring a prescription for PSE is only a hurdle for an addict. It’s not going to stop them altogether; though it will stop a legitimate consumer from realizing accessible symptom relief from a cold.
Coalition of pharmacy, health groups urges Congress to address compliance
NEW YORK A whole slew of health policy-makers, health-reform advocates, federal and state lawmakers, budget hawks and healthcare stakeholders — not to mention the Obama administration and the managed care industry — are desperately searching for ways to cut out-of-control healthcare spending and rein in the spiraling national deficit. But one of the biggest potential levers for curbing healthcare spending doesn’t seem to be getting the attention it deserves.
That lever, of course, would be an all-points program to improve patients’ adherence and compliance with their prescription drug therapy. Adopting a national strategy to elevate Americans’ abysmal medication compliance rate now pegged as low as 50% or less among all patients over the course of their drug therapy could yield tens, or even hundreds of billions of dollars in savings.
Much of that savings would come through improving patient outcomes and overall health by better-managed medication therapy, thus keeping people out of emergency rooms and critical-care centers. Tens of billions more would be realized by boosting productivity in the workplace as those patients regain their health or successfully manage their chronic conditions with the help of medication.
In the scramble for ways to cut health costs, improved compliance looks like some of the lowest of the low-hanging fruit. Estimates of how much non-adherence, non-compliance and non-persistence cost the U.S. healthcare system and economy each year range from $100 billion to $300 billion.
That’s a big drain on the U.S. economy. Enough to perhaps grab the attention of even the most fiscally jaded and distracted members of Congress, who are used to thinking in abstract billions of dollars for any piece of major legislation. To make sure it does, 27 pharmacy and healthcare organizations joined forces in mid-November to get the message to every senator and member of the House.
The letter those organizations jointly signed and sent Nov. 17 urged lawmakers to make patient adherence and compliance a central facet of any bill that emerges from the health reform negotiations now underway. Given the broad consensus represented by the coalition, the quality and reach of the organizations involved, and the huge savings they say could be achieved, it’s likely their message will at least get a hearing on Capitol Hill.