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LEGISLATION

Same Fight, New Ring

The FTC is taking its war against pay-for-delay agreements to the Senate’s super committee.

MICHAEL FITZHUGH

The Burrill Report

“While a lot of companies don’t engage in pay-for-delay settlements, the ones that do increase prescription drug costs for consumers and the government each year.”

Federal antitrust regulators are appealing to the Congressional super committee to forbid patent settlements that delay generic drug launches, a practice that critics say increases prescription drug costs for  consumers and the government.

The issue reached a flashpoint in May when a Federal Trade Commission analysis uncovered a record 31 such settlements between branded and generic drugmakers in fiscal 2010. Now the FTC has reignited the issue with a fresh review, reporting 28 such deals in fiscal 2011.

The FTC is now framing its long-running quest to put an end to the deals, which it views as anticompetitive, as an easy win for the super committee, which is hashing out plans to capture $400 billion or more in savings from government healthcare spending.

Generic drugs, which typically cost at least 20 to 30 percent less than the name-brand drugs they copy, play an essential role in holding down costs for taxpayer-funded health programs such as Medicare and Medicaid, says the FTC.

“While a lot of companies don’t engage in pay-for-delay settlements, the ones that do increase prescription drug costs for consumers and the government each year,” says FTC Chairman Jon Leibowitz. “Fortunately, Congress has the opportunity to fix this problem through the Joint Select Committee on Deficit Reduction -- and save the government and American taxpayers billions of dollars.”

To accomplish that, the FTC, Senator Chuck Grassley, R-Iowa, and Senator Herb Kohl, D-Wisconsin, are advocating for passage of The Preserve Access to Affordable Generic Drugs Act, a bill that would outlaw pay-for-delay settlements while continuing to allow other pharmaceutical patent agreements that don’t contain pay-for-delay provisions. The President’s budget for fiscal 2012 estimates that adoption of the legislation would save the federal government $8.79 billion over the next decade.

The Generic Pharmaceutical Association, the main lobbying group for generic drugmakers, says the FTC is taking the wrong approach. Settlements between the makers of generic and branded drugs, with or without payments, actually speed up the availability of generic drugs and save money for everyone by resolving litigation with uncertain outcomes, it says.

“Instead of lobbying the super committee to ban these pro-competitive, savings-generating settlements, the FTC and Congress should focus on initiatives that would continue to dramatically reduce prescription drug spending,” says Ralph Neas, the group’s CEO and president.

Generic drugmakers would instead like to see federal and state government funded health care programs pouring more money into the FDA’s Office of Generic Drugs to speed approval of generic medicines.



October 26, 2011
http://www.burrillreport.com/article-same_fight_new_ring.html

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