FDA declines to approve Watson reproductive drug
PARSIPPANY, N.J. — The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.
The FDA sent the companies a complete response letter for their progesterone vaginal gel in the 8% strength. The drug is used to reduce the risk of preterm birth in women with singleton gestation and short uterine cervical length in the second trimester of pregnancy. Columbia transferred rights to the drug to Watson earlier this month, leaving Watson with full responsibility for obtaining regulatory approval.
The FDA said in the letter that results from a clinical trial of the drug did not show the levels of statistical significance that the agency requires for approval of a drug after a single late-stage clinical trial and that it would require additional clinical trial data before it could approve it.
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A healthier society costs everybody less
WHAT IT MEANS AND WHY IT’S IMPORTANT — Budget cuts are never an easy thing to do. Even if slashing spending on this program or that program can help replenish the government’s coffers and reduce a budget deficit, somebody always ends up losing.
(THE NEWS: Healthcare providers can challenge Calif. Medicaid cuts, Supreme Court rules. For the full story, click here)
In the case of California, cuts to the state’s Medicaid program, called Medi-Cal, would put patient access to community pharmacies in jeopardy as many would not receive reimbursements sufficient to make up for the cost of medications. In fact, as several pharmacy groups challenging cuts to Medi-Cal said in January when a lower court blocked the 10% reimbursement rate cut, many prescription drugs already are reimbursed at break-even rates.
But the idea of cutting pharmacy reimbursement rates also oversimplifies the issue and ignores the many ways that pharmacies can help save money.
According to most sources, medication nonadherence costs the country’s healthcare system $290 billion per year in otherwise unneeded medical costs. But pharmacy services, such as medication therapy management, can help reduce those costs by allowing the pharmacist to consult directly with the patient about the importance of taking medications as directed by physicians and the potential consequences of failing to do so. Meanwhile, such services as vaccinations can head off a number of medical costs by preventing people from getting sick in the first place.
Cutting spending on pharmacy reimbursements might seem like a quick and effective way to save money, but it’s shortsighted and misses the point: In the long run, a healthier society costs everybody less.
I absolutely agree with this article and I am sure that cutting spending on pharmacy reimbursements is not the best step.Pharmacies can really help save money, because it's even hard to imagine how many things depends on nation's health.Healthcare industry is one of the most expensive,staying health needs costs.I think that government should assist to medical programs and pharmacies, because healthy people can boost an economy doing different job, and of course health society will cost everybody less.The main things are that pharmacies can really help to save money and healthy society is a base of strong state. Anna from http://britainloans.co.uk/
Healthcare providers can challenge Calif. Medicaid cuts, Supreme Court rules
ALEXANDRIA, Va. — The Supreme Court has sent a lawsuit challenging cuts to California’s Medicaid program back to a lower court.
The high court ruled 5-4 in the case of Douglas v. Independent Living Center of Southern California that healthcare providers could challenge Medicaid reimbursement cuts under the U.S. Constitution’s supremacy clause. The decision returns the case to the Ninth Circuit Court of Appeals, which had originally ruled that the providers had standing to sue.
The case was filed in 2008 in California’s Federal District Court, arguing that a 10% reimbursement cut in the Medi-Cal program violated the federal patient access law.
A group of pharmacy organizations, including the National Association of Chain Drug Stores, the National Community Pharmacists Association, the American Pharmacists Association and the National Alliance of State Pharmacy Associations, praised the ruling.
"Ensuring patient access to pharmacy care should not be compromised in an attempt to remedy budget challenges," NACDS president and CEO Steve Anderson said. "Community pharmacy provides unsurpassed value in improving health and reducing costs across the board."
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