Sorry, FTC: ‘Pay-for-delay’ isn’t going away
WHAT IT MEANS AND WHY IT’S IMPORTANT This week’s decision by the U.S. Second Circuit Court of Appeals could make political efforts to ban generic-branded patent settlements a lot more difficult.
(THE NEWS: Appeals court upholds decision to OK ‘pay-for-delay’ deals. For the full story, click here)
The Federal Trade Commission in particular, not to mention some members of Congress like Sen. Herb Kohl, D-Wis., has fought hard against so-called “pay-for-delay” settlements between branded and generic drug companies, contending that they delay patients’ access to generic drugs and cost consumers billions of dollars every year.
The concerns of opponents are understandable. Because generic and branded drug makers are supposed to be competitors, what seem on the surface like sweetheart deals must look positively Faustian to many people. But the judges in the appeals court affirmed that whatever their appearance, patent settlements don’t violate antitrust laws.
And the facts seem to support that decision. According to a report released in January by RBC Capital Markets, generic drug companies prevailed in 76% of cases that included settlements, but only in 48% of cases that went to trial. Meanwhile, according to a report released the same month by securities and investment banking firm Jefferies & Co., on average, patent settlements result in generic launch three years before patent expiration. Legally, a generic drug company must launch its version of a drug before or at the time of patent expiration.
While patent settlements often involve some type of monetary transaction, in many cases, the “pay” is in the form of a promise by the branded drug company not to launch an authorized generic, which is the branded drug sold under its generic name at a lower price. Under the Hatch-Waxman Act, the first generic drug maker to launch a knockoff of a branded drug is entitled to six months in which to compete directly with the branded version, but the authorized generic allows the branded drug maker to undercut the generic drug maker by marketing a supposedly “generic” version of its own.
Authorized generics have seen a bit of a pickup as well, and more activity on that front can be expected. On Tuesday, Greenstone, the generics arm of Pfizer, announced that it would create a new business called the Authorized Generics Alliance in order to market authorized generics under the Greenstone label.
J&J launches Every Mother, Every Child
NEW BRUNSWICK, N.J. Johnson & Johnson is seeking to aid the health of women and children in developing countries with a new initiative.
J&J’s Every Mother, Every Child effort is supporting the United Nations’ effort to reduce mortality in women and children by 2015. The effort includes treatments for intestinal worms, health information for pregnant women over existing mobile phones, research and development of new medicines for HIV and tuberculosis, and efforts focused on enhancing birth safety and improving health.
“We have a responsibility to contribute to a future in which women and children have the latest knowledge, technology and medicines to support good health,” said Johnson & Johnson chairman and CEO William Weldon. “Johnson & Johnson has a long history of advancing care for women and children, and we’re pleased to continue that legacy with this commitment.”
Many young women may be mistreating yeast infections, study finds
SKILLMAN, N.J. According to a recent survey of women ages 18 to 24 years commissioned by the Monistat brand, 61% of young women are unsure about which, if any, over-the-counter products can cure a yeast infection.
"Many women don’t realize that once they’ve identified they have a yeast infection, they can easily treat it on their own terms," stated Suzanne Gilberg-Lenz, a board-certified OB/GYN who practices in Beverly Hills, Calif., and a partner in the Monistat survey.
The survey also found more than 36% of women incorrectly believe that treating the symptoms of a yeast infection is the same as curing the infection. And 38% of women mistakenly believe a yeast infection only can be cured by a doctor’s prescription.
"The symptoms of a yeast infection vary greatly among individuals," Lenz said. "The classic symptoms … do not appear for all women. The important sign is always vaginal discomfort that develops out of the blue. If you are unsure, especially if you’ve never had a yeast infection, check with your doctor to make sure your symptoms aren’t actually the result of a sexually transmitted disease, bacterial infection or a combination of yeast and bacteria."
"If your yeast infection does not clear up, contact your doctor," Lenz added. "Once you’ve treated the infection, long-term, preventative measures, including changes to your diet and lifestyle, can help prevent future infections."