Federal court orders FDA to allow Watson diabetes drug launch
PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.
Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda’s Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.
Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson’s claim to shared exclusivity in marketing a generic version of Actos would improperly delay its launch of the drug.
Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.
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Enlisting pharmacy in better health outcomes
Every day now, it seems, health researchers keep coming up with new reasons why the troubled U.S. healthcare system needs to more effectively engage pharmacists and pharmacy technicians in its urgent search for more accessible and more cost-effective ways to deliver care and boost patients’ lifespans and quality of life.
Two new reasons emerged in the past few weeks. Both involved the release of reports detailing the results of two long-term studies showing the beneficial effects of vitamin use and of improved monitoring of diabetes patients. Both highlight the positive role pharmacists can play as patient counselors and disease managers.
The Journal of the American Medical Association released a study last Wednesday [Oct. 17] showing that long-term multivitamin use seems to lower cancer risk among men. Researchers tracked some 15,000 men over a period of more than 11 years and found that daily use of a multivitamin measurably reduced the risk of developing cancer compared with those taking a placebo.
Walgreens’ top pharmacy and health leader touted the findings and the role the chain’s pharmacists could play in encouraging men to take a daily multi. “Our pharmacists are available to discuss vitamin options with individuals and counsel them about potential side effects that certain ingredients can have with select prescriptions,” said Kermit Crawford, the company’s president of pharmacy, health and wellness. “Pharmacists can help customers make the right choice to get, stay and live well.” (See story here.)
Another study report, published in Diabetes Technology & Therapeutics, showed that “patients who tested at least once per day had the greatest reductions in A1C levels, compared with patients who tested less frequently or not at all,” according to Drug Store News senior editor Mike Johnsen in an Oct. 19 report. (See story here.). Researchers from medical device maker LIfescan also found that “patients who tested their blood glucose were more likely to take their diabetes medication as prescribed than patients who didn’t,” Johnsen reported.
Pharmacists, of course, can be key allies in helping diabetic patients both keep track of their glucose levels and stay adherent with their drug regimens to control the condition.
If you’re a pharmacist or pharmacy leader, what role are you or your pharmacy team playing to encourage healthier behaviors in your patients? You can share specific examples by clicking on the comment button — and as always, thank you for your participation.
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NCPA urges Pa. governor to approve state pharmacy bill
ALEXANDRIA, Va. — A group that lobbies on behalf of independent pharmacies is urging Pennsylvania Gov. Tom Corbett to sign a bill that would allow retail pharmacies to match the reimbursement terms, pricing and conditions that mail-order pharmacies negotiate exclusively with health insurance plans.
The National Community Pharmacists Association expressed hopes that Corbett would sign S.B. 201, which the Pennsylvania state Senate and House have unanimously approved.
“Quite simply, S.B. 201 is a significant step in the right direction for supporting local Pennsylvania jobs, increasing local tax revenue and providing citizens of Pennsylvania with the freedom of choice as to where they access their healthcare and medication needs, at absolutely no additional cost to the individual or healthcare system,” a letter from the NCPA to Corbett read.
The organization said there are 1,000 independent pharmacies in Pennsylvania that provide about 10,600 jobs, citing a Walgreens study conducted in April showing that 4-in-5 patients prefer community pharmacies over mail order, while a J.D. Power and Associates study indicates “growing dissatisfaction” with mail-order pharmacies despite many health plans requiring patients to use them. Most mail-order pharmacies are run by pharmacy benefit managers.
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As a pharmacist in Florida I would sure like to see this happen in our (Florida) state.