PHARMACY

Supreme Court to hear FDA preemption case

BY Drew Buono

WASHINGTON Last week, the U.S. solicitor general issued an opinion regarding the U.S. Supreme Court supporting preemption, saying the Food and Drug Administration approval of drug labeling preempts state law, now this matter will be handled directly by the Supreme Court in an upcoming case due to be heard on February 25.

The case, which brought out the views of the solicitor general, is Wyeth v. Diana, which concerns the Vermont Supreme Court’s interpretation of FDA law over the labeling of the antinausea drug Phenergan. This case has been appealed to the Supreme Court, which is deciding whether or not to accept it.

The case that is headed to the Supreme Court concerns the Warner-Lambert/Pfizer drug Rezulin, which is a Type 2 diabetes drug. The case, Warner-Lambert v. Kent is about how patients who claimed to have suffered personal harm from the drug alleged that Warner-Lambert concealed safety information from the FDA. The drug was removed from the market in 2000 and had liver risks described in the labeling.

After a district court ruled in favor of Warner-Lambert, the Second Circuit reversed on appeal, concluding that the previous Supreme Court ruling could not be applied to this case. In that case, the Supreme Court decided that federal law preempts claims of manufacturer liability for alleged misrepresentations made to the FDA. Warner-Lambert requested that the appeals court ruling be reversed and the respondents’ claims be dismissed.

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PHARMACY

Internet pharmacies make false claims regarding certification

BY Drew Buono

SOUTH FLORIDA Federal regulators are receiving complaints from the Better Business Bureau and other professional groups after discovering that some Internet pharmacies are falsely claiming to be certified by their organizations, according to South Florida’s Sun-Sentinel.

The pharmacies are stating that they are located in Canada and are therefore offering cheaper prices on drugs to its customers, many of whom are Florida’s elderly. Customers started complaining after they wither did not receive their medications or they got drugs that appeared questionable.

One of the companies that the Internet pharmacies claim to be certified by is PharmacyChecker.com. Over the last 18 months, PharmacyChecker has received about 100 complaints from customers who thought they certified the websites.

The Internet pharmacies are using fake logos and phone numbers to make them appear certified and legitimate to customers. The Canadian International Pharmacy Association, which has 25 member pharmacies that are government-licensed, has also been receiving several calls a week from American consumers about not receiving shipments from sites they thought were CIPA-approved.

The Federal Bureau of Investigation has started a special investigation of Internet pharmacy practices, including the trademark violations and other issues.

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Amylin launches SymlinPen for Type 2 diabetes

BY Drew Buono

SAN DIEGO Amylin Pharmaceuticals has released its new prescription device, the SymlinPen 120 and 60 pen-injector devices for administering the blood sugar controlling drug Symlin. The new devices feature simple, fixed dosing to improve mealtime glucose control.

The SymlinPen 120 features fixed dosing to deliver 60 or 120 micrograms of Symlin per dose. The SymlinPen 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of Symlin per dose. Both pen-injector devices can be conveniently stored at room temperature not to exceed 86 degrees F after first use.

“Symlin offers enhanced blood glucose control with potential weight loss for patients with diabetes using mealtime insulin, enabling them to do more to manage their diabetes,” said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. “The convenience of the new SymlinPen with simple, fixed dosing will make it easier for these patients using multiple daily injections to start and stay with Symlin.”

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