Drug & Device News

FDA Withdraws Approval of Avastin for Breast Cancer Treatment

The Food and Drug Administration (FDA) announced on Nov. 18, 2011 that it was had revoked its approval of the drug Avastin for the treatment of metastatic breast cancer. Avastin had been used in conjunction with the cancer drug paclitaxel for treating women with the type of metastatic breast cancer known as HER2 negative. This use was approved by the FDA using the accelerated approval process, but later tests and patient results showed that it only minimally slowed tumor growth, and that no correlation between the use of Avastin and greater longevity could be shown. In a release announcing the FDA's action, FDA Commissioner Margaret Hamburg said, “As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment.” However, although many women with metastatic breast cancer saw Avastin as part of their life-saving regimen of treatment, Hamburg said the FDA needed to withdraw its approval of the drug for their use because it “found after rigorous testing the side effects of Avastin were more damaging than the benefits.” These side effects include high blood pressure and hemorrhaging. Avastin remains FDA-approved for the treatment of certain types of colon, lung, kidney and brain cancers.

GSK Announces Federal Settlement

The U.S. Department of Justice (DOJ) has agreed in principle to accept $3 billion from British drug manufacturer GlaxoSmithKline to close civil and criminal investigations into the drug company's marketing and pricing practices. Federal authorities began investigating the company in 2004, leading to allegations that it may have marketed drugs for unapproved uses, overcharged public health programs and inappropriately used financial and other incentives to persuade doctors to prescribe certain of the company's products. Details of the settlement, which will be the largest drug company settlement yet for the federal government, are expected to be ironed out over the next several months. GlaxoSmithKline CEO Andrew Witty explained in a statement announcing the settlement that the agreement would resolve “difficult, long-standing matters which do not reflect the company that we are today.” Witty said that new procedures have now been put in place to ensure better compliance with U.S. law.

Another Chance in State Court

Pfizer Inc., the defendant in a state-court civil lawsuit, has asked the New Jersey Supreme Court to dismiss the plaintiff's claims because the primary issue it presents has already been decided in the company's favor in federal court. The suit, Gannon v. American Home Products, alleges that the plaintiff, Jamie Gannon, developed a brain tumor because of a polio vaccine he received decades earlier. He brought the state court suit against the manufacturer concurrently with a federal lawsuit alleging the federal government had negligently licensed the manufacturer to produce the vaccine. The federal case was dismissed after the court found Gannon could not possibly prove, based on the proffered evidence, that the virus contained in the vaccine causes cancer. That decision was affirmed by the U.S. Court of Appeals for the Third Circuit. After being notified of the federal courts' actions, Bergen County, NJ, Superior Court Judge Richard Donohue held that Gannon was collaterally estopped from relitigating causation, and dismissed the state court case. However, the Appellate Division reinstated it, saying there was enough evidence of causation to preclude summary dismissal. In addition, the appellate panel found the record insufficient for determining whether the plaintiff might intend to present additional evidence of causation in his state court action.

Competing Product
Manufacturer Raises
Concerns with the FDA

The FDA announced in November that it has begun performing tests on the ingredients used by pharmacists to make a compound drug prescribed by doctors to reduce the risks of pre-term births in women who have had at least one previous pre-term birth. Compounded hydroxyprogesterone caproate products have been prescribed for years by physicians for this purpose, but the first FDA-approved ready-made hydroxyprogesterone caproate product for prevention of pre-term birth ' Makena, manufactured by K-V Pharmaceuticals ' came to market only in early 2011. In October 2011, K-V Pharmaceuticals sent the FDA results of an investigation it had commissioned indicating that the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients and of compounded hydroxyprogesterone caproate products currently in commerce may not be consistent. Based on this information, the FDA launched its own probe. While the FDA did state in the release announcing its investigation that “as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product,” the agency also pointed out that it has not yet validated or affirmed K-V Pharmaceutical's findings. For further information, see www.fda.gov/NewsEvents/Newsroom/PressAn nouncements/ucm279098.htm.

FDA Withdraws Approval of Avastin for Breast Cancer Treatment

The Food and Drug Administration (FDA) announced on Nov. 18, 2011 that it was had revoked its approval of the drug Avastin for the treatment of metastatic breast cancer. Avastin had been used in conjunction with the cancer drug paclitaxel for treating women with the type of metastatic breast cancer known as HER2 negative. This use was approved by the FDA using the accelerated approval process, but later tests and patient results showed that it only minimally slowed tumor growth, and that no correlation between the use of Avastin and greater longevity could be shown. In a release announcing the FDA's action, FDA Commissioner Margaret Hamburg said, “As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment.” However, although many women with metastatic breast cancer saw Avastin as part of their life-saving regimen of treatment, Hamburg said the FDA needed to withdraw its approval of the drug for their use because it “found after rigorous testing the side effects of Avastin were more damaging than the benefits.” These side effects include high blood pressure and hemorrhaging. Avastin remains FDA-approved for the treatment of certain types of colon, lung, kidney and brain cancers.

GSK Announces Federal Settlement

The U.S. Department of Justice (DOJ) has agreed in principle to accept $3 billion from British drug manufacturer GlaxoSmithKline to close civil and criminal investigations into the drug company's marketing and pricing practices. Federal authorities began investigating the company in 2004, leading to allegations that it may have marketed drugs for unapproved uses, overcharged public health programs and inappropriately used financial and other incentives to persuade doctors to prescribe certain of the company's products. Details of the settlement, which will be the largest drug company settlement yet for the federal government, are expected to be ironed out over the next several months. GlaxoSmithKline CEO Andrew Witty explained in a statement announcing the settlement that the agreement would resolve “difficult, long-standing matters which do not reflect the company that we are today.” Witty said that new procedures have now been put in place to ensure better compliance with U.S. law.

Another Chance in State Court

Pfizer Inc., the defendant in a state-court civil lawsuit, has asked the New Jersey Supreme Court to dismiss the plaintiff's claims because the primary issue it presents has already been decided in the company's favor in federal court. The suit, Gannon v. American Home Products, alleges that the plaintiff, Jamie Gannon, developed a brain tumor because of a polio vaccine he received decades earlier. He brought the state court suit against the manufacturer concurrently with a federal lawsuit alleging the federal government had negligently licensed the manufacturer to produce the vaccine. The federal case was dismissed after the court found Gannon could not possibly prove, based on the proffered evidence, that the virus contained in the vaccine causes cancer. That decision was affirmed by the U.S. Court of Appeals for the Third Circuit. After being notified of the federal courts' actions, Bergen County, NJ, Superior Court Judge Richard Donohue held that Gannon was collaterally estopped from relitigating causation, and dismissed the state court case. However, the Appellate Division reinstated it, saying there was enough evidence of causation to preclude summary dismissal. In addition, the appellate panel found the record insufficient for determining whether the plaintiff might intend to present additional evidence of causation in his state court action.

Competing Product
Manufacturer Raises
Concerns with the FDA

The FDA announced in November that it has begun performing tests on the ingredients used by pharmacists to make a compound drug prescribed by doctors to reduce the risks of pre-term births in women who have had at least one previous pre-term birth. Compounded hydroxyprogesterone caproate products have been prescribed for years by physicians for this purpose, but the first FDA-approved ready-made hydroxyprogesterone caproate product for prevention of pre-term birth ' Makena, manufactured by K-V Pharmaceuticals ' came to market only in early 2011. In October 2011, K-V Pharmaceuticals sent the FDA results of an investigation it had commissioned indicating that the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients and of compounded hydroxyprogesterone caproate products currently in commerce may not be consistent. Based on this information, the FDA launched its own probe. While the FDA did state in the release announcing its investigation that “as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product,” the agency also pointed out that it has not yet validated or affirmed K-V Pharmaceutical's findings. For further information, see www.fda.gov/NewsEvents/Newsroom/PressAn nouncements/ucm279098.htm.