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Pharma Pay-To-Delay Foe Leibowitz Leaving FTC
Supreme Court will still take up the matter next month
February 1, 2013 | By Eric Palmer
FTC Chairman Jon Leibowitz, who has been a burr under the saddle of branded drug makers, is stepping down. That won't derail the U.S. Supreme Court from hearing a case next month over one of his favorite subjects, pay-to-delay arrangements. Under those deals, branded drug makers pay their generics-producing competitors a settlement in patent litigation to postpone launching copycats that will cut into profits. Just last month, the FTC put out a report claiming that the practice is costing taxpayers $3.5 billion a year. His fight against pay-to-delay was mentioned by the FTC as one of his biggest accomplishments in his four years as chairman. The lack of love between the FTC and the industry on this issue was evident when Generic Pharmaceutical Association(GPhA) CEO Ralph G. Neas responded to the FTC report with this: "The FTC is wrong on the facts, wrong on the public policy and wrong on the law." Release | More
Here's the FTC release:
FTC Chairman John Leibowitz To Step Down This Month
For Release: 02/01/2013
FTC Chairman Jon Leibowitz to Step Down This Month
After nearly four years as the head of the Federal Trade Commission, Chairman Jon Leibowitz today announced he will step down on February 15, 2013. He has been a Commissioner since September 3, 2004.
Leibowitz, who became FTC chair in the wake of the economic downturn in March 2009,continued the agency’s groundbreaking work on consumer protection and competition issues.
“I have been honored to head this extraordinary, bipartisan Commission and to work alongside the best staff in federal government,” said Chairman Leibowitz. “Our small but mighty agency has safeguarded the privacy of Americans and stopped predatory financial practices by companies taking advantage of cash-strapped consumers. Our antitrust enforcement has helped contain health care and drug costs, and helped reduce prices and increase innovation for smartphones, computer chips and other high-tech products.”
Setting his priorities as protecting consumer privacy, stopping financial scammers, and promoting competition in health care and high-tech markets, Leibowitz steered the Commission to major enforcement actions and cutting-edge policy work.
In the past four years, enforcement has been a major priority at the FTC. Most recently, the Commission announced a landmark agreement with Google to ensure consumers would continue to be able to buy a variety of high-tech devices from smartphones to games to tablets. The settlement gives competitors access to standard-essential patents, and ensures that companies that advertise on Google’s website will have more flexibility to use rival search engines.
Protecting Consumer Privacy
During the last few years, Leibowitz has worked to raise the profile of privacy practices through law enforcement, consumer education and policy initiatives. FTC settlement orders against Google and Facebook let the companies move on and innovate for consumers while requiring comprehensive privacy programs and affirmative choice for material privacy changes, and prohibiting privacy misrepresentations.
During the last few years, Leibowitz has worked to raise the profile of privacy practices through law enforcement, consumer education and policy initiatives. FTC settlement orders against Google and Facebook let the companies move on and innovate for consumers while requiring comprehensive privacy programs and affirmative choice for material privacy changes, and prohibiting privacy misrepresentations.
During Leibowitz’s tenure, the FTC issued a landmark report setting forth best privacy practices for businesses and updated the Children’s Online Privacy Protection Rule that strengthens kids’ privacy by requiring that companies get parents’ permission before collecting personal information from their children under 13. The FTC’s final report on privacy endorsed three principles – privacy by design, greater transparency, and more consumer choice – to help ensure consumer privacy and business innovation. The report encouraged businesses to improve their privacy practices through self-regulation, including a Do Not Track system, which remained a priority for Leibowitz.
Fighting Last Dollar Fraud
During Leibowitz’s tenure, the FTC has filed more than 50 law enforcement actions to stop “last dollar” scams that prey on consumers in financial distress, such as foreclosure “rescue” and mortgage modification schemes, phony debt-reduction and credit-repair services, and bogus government grant opportunities, job scams, and get-rich quick frauds, with many state Attorneys General as partners.
In 2011, as a result of one of the largest judgments imposed in an FTC settlement, the agency returned almost $108 million to more than 450,000 consumers – about 1 percent of all mortgage holders in the United States – who allegedly were overcharged or had their mortgage loans mishandled by Countrywide while they were in default or bankruptcy. The company later settled charges that it illegally assessed more than $36 million of servicing fees against struggling homeowners, and agreed to refund or reverse all of those charges.
Promoting Competition in Health Care
Under Leibowitz’s leadership, the Commission continued to take aggressive, bipartisan action to stop sweetheart deals in which branded drug manufacturers allegedly paid potential generic rivals to delay their introduction of lower-cost pharmaceuticals – deals that the agency estimates cost consumers and taxpayers billions of dollars annually. One of the FTC’s most important “pay-for-delay” cases, against an agreement that postponed generic competition for the testosterone-replacement drug AndroGel, will be argued before the Supreme Court on March 25, 2013. In another recent case involving generic competition for the wakefulness drug Provigil, the Court of Appeals for the Third Circuit issued a key ruling that supports the FTC’s position on the anticompetitive impact of pay-for-delay deals.
Under Leibowitz’s leadership, the Commission continued to take aggressive, bipartisan action to stop sweetheart deals in which branded drug manufacturers allegedly paid potential generic rivals to delay their introduction of lower-cost pharmaceuticals – deals that the agency estimates cost consumers and taxpayers billions of dollars annually. One of the FTC’s most important “pay-for-delay” cases, against an agreement that postponed generic competition for the testosterone-replacement drug AndroGel, will be argued before the Supreme Court on March 25, 2013. In another recent case involving generic competition for the wakefulness drug Provigil, the Court of Appeals for the Third Circuit issued a key ruling that supports the FTC’s position on the anticompetitive impact of pay-for-delay deals.
The FTC also continued its campaign to identify and challenge health care mergers that would harm competition and drive up the cost of health care for both consumers and employers. The Commission has successfully acted to block hospital mergers in Pennsylvania, Ohio and Illinois, as well as deals to consolidate lab services and physician practices. The hospital merger victories marked a turning point for the government after years of disappointing court rulings in this area. Another important FTC case in this area, challenging the merger of two hospitals in Albany, Georgia, also will be decided before the Supreme Court during the current term.
Trending in Technology
Another priority under Chairman Leibowitz was making sure that competition continued to thrive in fast-moving technology industries. In addition to the settlement with Google, the Commission reached another landmark agreement that prevented Intel Corp. from suppressing competition in the market for computer chips and opened the door to renewed competition. The settlement restored competition that was lost as a result of Intel’s previous anticompetitive tactics, while allowing the company to innovate and offer competitive pricing.
Another priority under Chairman Leibowitz was making sure that competition continued to thrive in fast-moving technology industries. In addition to the settlement with Google, the Commission reached another landmark agreement that prevented Intel Corp. from suppressing competition in the market for computer chips and opened the door to renewed competition. The settlement restored competition that was lost as a result of Intel’s previous anticompetitive tactics, while allowing the company to innovate and offer competitive pricing.
The FTC also took steps to rein in the alleged misuse of standard-essential patents, which can lead to patent hold-up and ultimately higher prices for popular devices such as smart phones, laptop and tablet computers, and gaming consoles. The Commission made the case publicly – and through law enforcement actions such as the Google consent decree – that companies should be restricted from seeking injunctions on standard-essential patents if they are bound by prior commitments to license their standard-essential patents on fair, reasonable, and non-discriminatory terms.
In addition, the FTC launched an initiative to enhance its longstanding program to make sure the agency’s rules are up-to-date, effective and not overly burdensome.
In joining the Commission, Leibowitz resumed a long career of public service. He was the Democratic Chief Counsel and Staff Director for the U.S. Senate Antitrust Subcommittee from 1997 to 2000, where he focused on competition policy and telecommunications matters. He served as Chief Counsel and Staff Director for the Senate Subcommittee on Terrorism and Technology from 1995 to 1996 and the Senate Subcommittee on Juvenile Justice from 1991 to 1994. In addition, he served as Chief Counsel to Senator Herb Kohl from 1989 to 2000. Leibowitz worked for Senator Paul Simon from 1986 to 1987. In the private sector, Leibowitz served most recently as Vice President for Congressional Affairs for the Motion Picture Association of America – from 2000 to 2004 – and worked as an attorney in private practice in Washington from 1984 to 1986.
A Phi Beta Kappa graduate of the University of Wisconsin with a B.A. in American History (1980), Leibowitz graduated from the New York University School of Law in 1984. He is a member of the District of Columbia Bar.
He lives in Bethesda with his wife, Ruth Marcus, and his two daughters.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC's online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.
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Thank You Fierce Pharma, Mr Palmer, and Mr. Leibowitz.
For More, see Pharmalot:
Too Late For Pharma: FTC Chair Leibowitz Is Leaving
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