Drug & Device News

FTC Finds Pay-for-Delay on the Rise

A Federal Trade Commission (FTC) report says that in fiscal year 2012, name-brand and would-be generic pharmaceuticals manufacturers entered into 40 potential “pay for delay” agreements, a sharp increase from previous years. These types of deals are currently under scrutiny by the U.S. Supreme Court, which has been asked to decide whether they promote unlawful monopolies in the field of drug sales. “Sadly, this year's report makes it clear that the problem of pay-for-delay is getting worse, not better,” said FTC Chairman Jon Leibowitz in an FTC release. “More and more brand and generic drug companies are engaging in these sweetheart deals, and consumers continue to pay the price. Until this issue is resolved, we will all suffer the consequences of delayed generic entry ' higher prices for consumers, businesses, and the U.S. taxpayer.” U.S. regulators are not the only ones turning a jaundiced eye on the concept of pay for delay: For example, on Jan. 31, European Union regulators formally accused drug makers Johnson & Johnson and Novartis of colluding to keep generic versions of the drug fentanyl out of the Dutch market.

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Does Zoloft Work?

A class action lawsuit has been filed against Pfizer Inc., the maker of antidepressant Zoloft. According to plaintiff attorney Michael Baum, senior managing partner at Los Angeles-based Baum, Hedlund, Aristei & Goldman, “This case is not a fraud-on-the-FDA case. It's a claim that the prescribing doctors and patients have been misinformed or under-informed about Zoloft's inability to outperform placebos in many trials in their advertising and labeling that went to the public and to media and to patients and physicians. They were being misled.” In response, Pfizer spokesman Steve Danehy issued an e-mailed statement, in which he said, “Pfizer believes the lawsuit filed in California is groundless and is based largely on information first published over three years ago that has been widely criticized by many experts in the mental health field. Moreover, plaintiffs in this putative class action seek refunds for Zoloft, even though FDA approved the medicine for the treatment of depression and their physicians prescribed it for this same purpose, under a legally unsupportable theory that FDA never should have approved the medicine.”

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Rabies Caused Organ Recipient's Death

The Centers for Disease Control (CDC) confirmed in a March 15 release that a man who recently died in Maryland succumbed to rabies he contracted from an infected organ donor. The Maryland Department of Health opened an investigation into the man's death in early March, and discovered that the deceased had had no known contact with an infected animal. This led to an investigation into the cause of the organ donor's 2011 death, which, at that time, was not suspected of being rabies-related. New tests showed that both the Florida donor and the Maryland organ recipient died of a type of rabies found in raccoons, dogs and other animals. This case is unusual not only because it is the first documented organ-transplant rabies death since 2004, but also because the Maryland organ recipient showed no symptoms until more than a year after the transplant. The normal incubation period for rabies is one to three months.

Three other patients received organs donated by the infected Florida donor. They were notified and put on rabies preventive treatment. According to the CDC's release, organ donors usually are not screened for rabies, as the number of rabies-related deaths in the United States each year is usually fewer than three, and the period of time needed to test for rabies will generally be too long to keep the donated organs viable for use in recipients.

'

FTC Finds Pay-for-Delay on the Rise

A Federal Trade Commission (FTC) report says that in fiscal year 2012, name-brand and would-be generic pharmaceuticals manufacturers entered into 40 potential “pay for delay” agreements, a sharp increase from previous years. These types of deals are currently under scrutiny by the U.S. Supreme Court, which has been asked to decide whether they promote unlawful monopolies in the field of drug sales. “Sadly, this year's report makes it clear that the problem of pay-for-delay is getting worse, not better,” said FTC Chairman Jon Leibowitz in an FTC release. “More and more brand and generic drug companies are engaging in these sweetheart deals, and consumers continue to pay the price. Until this issue is resolved, we will all suffer the consequences of delayed generic entry ' higher prices for consumers, businesses, and the U.S. taxpayer.” U.S. regulators are not the only ones turning a jaundiced eye on the concept of pay for delay: For example, on Jan. 31, European Union regulators formally accused drug makers Johnson & Johnson and Novartis of colluding to keep generic versions of the drug fentanyl out of the Dutch market.

'

Does Zoloft Work?

A class action lawsuit has been filed against Pfizer Inc., the maker of antidepressant Zoloft. According to plaintiff attorney Michael Baum, senior managing partner at Los Angeles-based Baum, Hedlund, Aristei & Goldman, “This case is not a fraud-on-the-FDA case. It's a claim that the prescribing doctors and patients have been misinformed or under-informed about Zoloft's inability to outperform placebos in many trials in their advertising and labeling that went to the public and to media and to patients and physicians. They were being misled.” In response, Pfizer spokesman Steve Danehy issued an e-mailed statement, in which he said, “Pfizer believes the lawsuit filed in California is groundless and is based largely on information first published over three years ago that has been widely criticized by many experts in the mental health field. Moreover, plaintiffs in this putative class action seek refunds for Zoloft, even though FDA approved the medicine for the treatment of depression and their physicians prescribed it for this same purpose, under a legally unsupportable theory that FDA never should have approved the medicine.”

'

Rabies Caused Organ Recipient's Death

The Centers for Disease Control (CDC) confirmed in a March 15 release that a man who recently died in Maryland succumbed to rabies he contracted from an infected organ donor. The Maryland Department of Health opened an investigation into the man's death in early March, and discovered that the deceased had had no known contact with an infected animal. This led to an investigation into the cause of the organ donor's 2011 death, which, at that time, was not suspected of being rabies-related. New tests showed that both the Florida donor and the Maryland organ recipient died of a type of rabies found in raccoons, dogs and other animals. This case is unusual not only because it is the first documented organ-transplant rabies death since 2004, but also because the Maryland organ recipient showed no symptoms until more than a year after the transplant. The normal incubation period for rabies is one to three months.

Three other patients received organs donated by the infected Florida donor. They were notified and put on rabies preventive treatment. According to the CDC's release, organ donors usually are not screened for rabies, as the number of rabies-related deaths in the United States each year is usually fewer than three, and the period of time needed to test for rabies will generally be too long to keep the donated organs viable for use in recipients.

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