PHARMACY

Solicitor General speaks out against Vermont’s FDA pre-emption ruling

BY Drew Buono

WASHINGTON U.S. Solicitor General Paul Clement has issued an opinion to the Supreme Court supporting preemption, saying that the Food and Drug Administration’s approval of a drug label preempts state law.

Clement recently disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug phenergan. In the case Wyeth v. Diana Levine, the Vermont Supreme Court “erroneously interpreted” the law by saying the FDA’s approval of drug labels is only a “first step,” according to the solicitor general. The drug’s labeling recommends deep intramuscular injection and describes how to avoid intra-arterial injection, which can cause serious adverse events.

At issue is whether patients can sue a drug maker over a product they believe caused them harm at the state level if the FDA has approved a drug. The U.S. Supreme Court has agreed to review a case involving drug preemption in February involving Rezulin, a diabetes drug made by Parke-Davis/Warner-Lambert.

The Wyeth case has been appealed to the U.S. Supreme Court, but the justices have not decided whether to accept it.

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FDA approves Depomed’s 1,000 mg Glumetza

BY Drew Buono

MENLO PARK, Calif. Depomed has received approval from the Food and Drug Administration for a 1,000 mg strength of Glumetza tablets. Glumetza is used as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes.

“This approval is good news for patients with Type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day,” stated Carl Pelzel, president and chief executive officer of Depomed. “The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2,000 mg/day as tolerated. We believe this 1,000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycemic control: the original Glumetza 500 mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1,000 mg tablets, which require fewer tablets to hit the target dose. We are working very closely with our commercial supplier, Biovail, to make these tablets commercially available in the United States in the near future.”

Depomed acquired exclusive U.S. rights to the 1,000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Glumetza had sales of $3.8 million in the third quarter of 2007.

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Ivans launches LIME Medicare Internet solution

BY Drew Buono

STAMFORD, Conn. Ivans, a technology company that provides Medicare connectivity solutions and services has unveiled its new product, an Internet solution for healthcare providers that processes Medicare transactions, called LIME.

The goal of the program will be to save providers time and money through its elimination of manual searches and by streamlining the claims process so claims are paid faster and more accurately. The program is approved by the Centers for Medicare and Medicaid Services and is compliant with the Health Insurance Portability and Accountability Act.

Using LIME, providers are able to process Medicare claims 10 times faster than dial-up modems. Providers indicated that while it used to take one hour to process three claims, by using the new program 30 claims can be processed during that same time period. Because this is a multi-user solution that can be used for other Medicare transactions such as eligibility and claims remittance, the time and money saved in a one-year period is equivalent to three staff members working full-time.

Currently, more than 100,000 part A and part B healthcare providers are supported by Ivans solutions.

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