KHN Morning Briefing

Summaries of health policy coverage from major news organizations

Federal Appeals Court Declines To Reconsider ‘Pay-For-Delay’ On Generic Drugs

A federal appeals court on Tuesday said it will not revisit its decision to uphold settlements that allow pharmaceutical companies to pay competitors to keep generic versions of their drugs off the market, The Wall Street Journal reports. "In April, the U.S. Second Circuit Court of Appeals [in New York] affirmed the legality of a settlement in which Bayer AG, in essence, paid Barr Pharmaceuticals Inc., a potential generic competitor, to drop its patent challenge to Cipro, a Bayer antibiotic." Drug purchasers including Rite Aid and CVS Caremark challenged the settlement, which are known as "pay-for-delay." The next stop could be the U.S. Supreme Court (Bray, 9/8).

Reuters: "On April 29, a three-judge panel in New York upheld a lower court's ruling dismissing objections to Bayer AG paying Teva Pharmaceutical Industries Inc'sBarr Laboratories to prevent it from bringing to market a version of the anthrax drug Cipro. But the panel invited further review by the full nine-judge panel of the U.S. Court of Appeals for the 2nd Circuit, which published an order Tuesday denying the rehearing. ... The Federal Trade Commission has lobbied hard to outlaw what it calls 'pay for delay' deals because of the antitrust implications. … The FTC has said 'pay for delay' cost American consumers $3.5 billion a year in higher prescription drug prices" (McCool, 9/7).

In other pharmaceutical industry news, Reuters reports, in a separate story, that drugmaker Wyeth paid ghostwriters to tout the benefits of hormone replacement therapy, according to studies published in medical journals. "Dr. Adriane Fugh-Berman of Georgetown University Medical Center in Washington and colleagues analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements, many of them using documents from judicial trials. They said Wyeth, now owned by Pfizer, paid a medical communication company called DesignWrite $25,000 to ghostwrite articles on clinical studies, including four testing low-dose Prempro, the company's combination estrogen-progestin therapy." Pfizer challenged the report, saying Fugh-Berman was paid as an expert witness for plaintiffs in hormone therapy litigation and that she could not verify any inaccuracies in the peer-reviewed articles (Steenhuysen, 9/7).

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