Senate Panel Vote: Limit Pay-To-Delay Generic Deals

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bribeThe Senate Judiciary Committee passed a bill making it harder for drug makers to strike those ‘pay-for-delay’ deals in which a brand-name pharma company shovels some money to a generic maker to hold off introducing a lower-priced copycat medication.

The bill, which reports say passed 12-7 along party lines, would allow drug makers to strike a deal only if they provide ‘clear and convincing evidence’ that an agreement doesn’t stymie competition. How that will be proven is unclear. Herb Kohl, the Wisconsin Democrat who introduced the bill, opposes any attempt to lower the threshold of evidence, although the bill was originally tougher - it would have banned these deals altogether.

The Federal Trade Commission, which opposes ‘pay-to-delay’ deals as anti-competitive, estimates that ending ‘pay-to-delay’ deals could save consumers at least $35 billion and save the federal government nearly $12 billion over the next decade.

“By taking this action, the Committee clearly recognizes the very real danger that these sweetheart deals pose to Americans struggling to pay their medical bills,” says FTC chairman Jon Leibowitz, in a statement. “Consumers must wait – sometimes years – for far less expensive generic drugs when branded pharmaceutical companies pay off their generic competitors to stay out of the market.”

In announcing the vote, Kohl noted that the FTC last February filed an antitrust case alleging Solvay struck a 2006 deal over a hormone-boosting drug with generic makers to delay their versions for nine years. The agency alleged that Solvay agreed to share profits as long as generics weren’t launched until 2015.

But Kathleen Jaeger, who heads the Generic Pharmaceutical Association, says her membership is “deeply disappointed” the bill was passed out of the committee and tells The Wall Street Journal that the trade group will still push hard to get the bill changed. Most senators, she adds, probably don’t realize the deals save consumers money, not cost them money as the FTC and others charge.

She pointed to a case involving Cephalon’s Provigil pill for narcolepsy. In late 2005, the drug maker struck deals with several generic makers who had challenged the Provigil patent. Cephalon settled the lawsuit by paying them $200 million and allowing product launches several years before the patent expiration, suggesting consumers would get access to cheaper generics before the patent expired.

The FTC is challenging the settlement, the Journal reminds us, by arguing Cephalon’s payments bought it market exclusivity and that if patent challenges prevailed, consumers may have had access to lower-cost generics sooner.

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  1. Well — the Provigil example — as Kathleen Jaeger cited it, is proof of the transparently specious position of big pharma, here.

    If that is her lead example, then phrma’s in trouble.

    That patent suit was likely going to invalidate the Provigil patents, making the generic available in 2005. As it now stands, it will be several years yet before the generics launch. And all the while the consumer suffers (while in this case, both the braned, and the generic pharma manufacturer line their pockets) — is there ANY evidence that Cephalon has not made at least a 10,000% return (ROI) on Provigil? None.

    So, a “clear and convincing” evidence standard is a reasonable political compromise to acheive a fairly effective ban on the practice, as it now stands. Last month, I detailed a Schering-Poulgh drug on which patent exclusivity has now run 32 years (compared to the 17 Congress intended, when last it addressed duration). That drug? A cancer treatment called Temodar.

    That practice needs to end. We are spending billions more than we need to, for the very same compounds — many of which have been on the market, as exclusively branded drugs for more than twelve years, now. The ROIs here are staggering.

    Great post, Ed.

    Namaste

  2. UPDATED, here: I just did some digging, and I have found the full-text of Senator Kohl’s amendment. It is linked, as a PDF, in the below post.

    I’ve also tried to set out, in plain English, what the “clear and convincing” evidence might look like, to avoid the delay agreement being declared unlawful, under Kohl’s formulation of the seven tests.

    Do take a look. “Whiskey for my men; beer for my horses.

    Namaste

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