Drug & Device News

'In a release, Chairwoman Edith Ramirez said, following the ruling: “The Supreme Court's decision is a significant victory for American consumers, American taxpayers, and free markets. The Court has made it clear that pay-for-delay agreements between brand and generic drug companies are subject to antitrust scrutiny, and it has rejected the attempt by branded and generic companies to effectively immunize these agreements from the antitrust laws. With this finding, the Court has taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices.” But others are not so certain that pay-for-delay settlements will go the way of the dinosaurs. “These agreements have been a major priority for [the FTC] for more than a decade,” said Jeffrey Brennan, a partner at McDermott Will & Emery, who once worked on the issue as an FTC lawyer. “But until recently, they couldn't get past motions to dismiss. Now they won't get kicked out of court. But they don't have the resources to pursue every one of these agreements. And companies are making risk assessments starting now.”

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DOJ Brings Action Against Apparently Stubborn Drug Manufacturer

The Department of Justice (DOJ) announced June 20 that it is taking action against Shreveport, LA, drug manufacturer Sage Pharmaceuticals Inc., due to alleged violations of the Federal Food, Drug and Cosmetics Act. The company, which in 2000 was previously enjoined from selling two unapproved drug products, continues to market unapproved drug products, according to the DOJ release. These include prescription pain killers and over-the-counter cough and cold remedies. The suit seeks to permanently shut Sage Pharmaceuticals, at least until it comes into compliance with FDA regulations.'

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Thousands of International Online Pharmacies Shut Down

In the final week of June, the FDA announced that it had taken regulatory action against nearly 10,000 online sellers of pharmaceutical products, 1,677 of which were completely shut down. The agency worked in conjunction with federal and international authorities on the effort, dubbed Operation Pangea VI, to curtail U.S. sales of unapproved drugs by these companies to U.S. consumers. According to an FDA release, many of the affected companies' websites “appeared to be operating as a part of an organized criminal network that falsely purported its websites to be 'Canadian Pharmacies.' These websites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs they advertised as 'brand name' and 'FDA approved,'” when, in fact, they were neither of these. Some of the websites also used U.S. pharmaceutical purveyors' names in their URLs in order to trick American consumers into thinking the online pharmacies were affiliated with these trusted sources.'

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Pay-for-Delay Agreements Not Immune to Antitrust Scrutiny

Consumers, government entities and others interested in the reduction of the costs of medications are celebrating the Federal Trade Commission's (FTC) victory before the U.S. Supreme Court in FTC v. Actavis Inc . The court's ruling in the case means the FTC has the authority to step in and challenge so-called pay-for-delay agreements between patent-holding pharmaceuticals manufacturers and would-be competitors seeking to market generic versions of the patented drugs.

The FTC has long contended that these types of agreements are often entered into as a means of maintaining a monopoly on a certain drug market, allowing the patent holder to charge inflated prices to consumers who are left without other options. But the lower courts that addressed the FTC's contention that it needed to review a pay-for-delay agreement between two pharmaceuticals manufacturers concluded that the agency had no case so long as the patent at issue was still in force. They reasoned that, even if the patent might ultimately prove invalid, opening the door for generic sales, the public policy in favor of settlement of legal disputes took precedence, and the parties to those disputes could not be forced to go to litigation in order to avoid antitrust scrutiny.

'In a release, Chairwoman Edith Ramirez said, following the ruling: “The Supreme Court's decision is a significant victory for American consumers, American taxpayers, and free markets. The Court has made it clear that pay-for-delay agreements between brand and generic drug companies are subject to antitrust scrutiny, and it has rejected the attempt by branded and generic companies to effectively immunize these agreements from the antitrust laws. With this finding, the Court has taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices.” But others are not so certain that pay-for-delay settlements will go the way of the dinosaurs. “These agreements have been a major priority for [the FTC] for more than a decade,” said Jeffrey Brennan, a partner at McDermott Will & Emery, who once worked on the issue as an FTC lawyer. “But until recently, they couldn't get past motions to dismiss. Now they won't get kicked out of court. But they don't have the resources to pursue every one of these agreements. And companies are making risk assessments starting now.”

”

DOJ Brings Action Against Apparently Stubborn Drug Manufacturer

The Department of Justice (DOJ) announced June 20 that it is taking action against Shreveport, LA, drug manufacturer Sage Pharmaceuticals Inc., due to alleged violations of the Federal Food, Drug and Cosmetics Act. The company, which in 2000 was previously enjoined from selling two unapproved drug products, continues to market unapproved drug products, according to the DOJ release. These include prescription pain killers and over-the-counter cough and cold remedies. The suit seeks to permanently shut Sage Pharmaceuticals, at least until it comes into compliance with FDA regulations.'

”

Thousands of International Online Pharmacies Shut Down

In the final week of June, the FDA announced that it had taken regulatory action against nearly 10,000 online sellers of pharmaceutical products, 1,677 of which were completely shut down. The agency worked in conjunction with federal and international authorities on the effort, dubbed Operation Pangea VI, to curtail U.S. sales of unapproved drugs by these companies to U.S. consumers. According to an FDA release, many of the affected companies' websites “appeared to be operating as a part of an organized criminal network that falsely purported its websites to be 'Canadian Pharmacies.' These websites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs they advertised as 'brand name' and 'FDA approved,'” when, in fact, they were neither of these. Some of the websites also used U.S. pharmaceutical purveyors' names in their URLs in order to trick American consumers into thinking the online pharmacies were affiliated with these trusted sources.'

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