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The health-care reform bill continues to improve

Andrew Pollack reports that the White House wants a shorter period of patent exclusivity for biologics -- which is very, very good news.

Both the House and Senate bills would provide a brand-name biologic drug with 12 years of protection from competition, even if the drug’s patents expire before that.

Until now it looked like the matter was settled because the 12-year period got wide bipartisan support in both chambers. And with Congress having much more prominent issues to grapple with, there seemed little chance this issue would be reopened.

That has changed. Mr. Obama apparently met with Congressional leaders and specified a shorter exclusivity period as one of the changes he wanted in the legislation, according to James Greenwood, the president of the Biotechnology Industry Organization, the biotech trade group, which favors the 12-year period.

For a good look at the whole issue, read this article. But the quick version is that there's serious money in generic competition for biologics: $378 billion over two decades, according to one analysis. I've heard the White House is likely to push for a 10-year exclusivity window, which isn't a revolutionary change, but it's better. And it's part of the continuing surprise that is the final days of health-care reform: The bill seems to be getting better, not worse, as it nears the finish line.

By Ezra Klein  |  January 15, 2010; 5:31 PM ET
Categories:  Health Reform  
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throw all the democrats out and their health care with them in the bath water . it is all dirty

Posted by: mahye1935 | January 15, 2010 5:59 PM | Report abuse

And right on cue, here's Big Pharma threatening to go to the mattresses over this change to the bill:

(cue the Darth Vader empire strikes back theme song here)

Posted by: zeppelin003 | January 15, 2010 6:08 PM | Report abuse

Obama seems to be all about political theater these days. There is no way a two year shortening of the data exclusivity window generates $378 billion. No way.

In fact, I'd wager it saves nothing. The technical, patent, and data exclusivity hurdles to FOBs are still enormous. Countries that have very liberal FOB laws still have little to no competition in biologics.

This is pure show by Obama, and faux indignation by PhRMA as 10 years is still more than they ever dreamed of six months ago. There will be no market for FOBs in this country in my lifetime.

Posted by: bmull | January 15, 2010 6:57 PM | Report abuse

Obama is showing more of his operating style: competence, making details right when he can, good ordering of priorities. A very fine sense of what is possible.

Obama didn't waste his political capital on reform, but held it in reserve until it mattered.

We're so unaccustomed to competence that many keep trying to guess at a lower level, and missing.

This guy's above most all of the commentators, well above.

Posted by: HalHorvath | January 15, 2010 7:01 PM | Report abuse

A few quibbles:

The issue is not about the period of time for patent exclusivity. A patent is a patent. The issue is about data exclusivity which is special for all drugs. Since it can take ten years or more after the patent is approved to achieve regulatory approval, drugs are given periods of data exclusivity which can run longer than the original patent.

Currently the effective period of patent/data exclusivity for "biologics" is infinite. This is because there is no regulatory scheme for the approval of generic "biologics" (this is because it is close to impossible to show that a "biologic" produced by a different process is identical to the original, hence the term "biosimilar"). Since a competitor's "biosimilar" may not be 100% identical to the original, they would have to run clinical trials on their "biosimilar" to show equivalent efficacy (this is not required for traditional drugs where only dose equivalence needs to be shown). Clinical trials are a prohibitively expensive proposition for merely selling a cheaper copy, hence no one does it.

Everyone expects the FDA to come up with a regulatory scheme for this but I don't think it is quite in place yet (and you can count on lengthy challenges to whatever they do). Until the FDA finalizes the "biosimilar" regulatory scheme the potential for "biosimilars" is just that, potential.

Posted by: ethelmertz | January 15, 2010 7:24 PM | Report abuse

To be fair, this is exactly what Obama promised since the beginning. he said that he was going to wait until conference to get deeply involved in shaping the content of the bill. It just ended up taking longer to get here than most of us expected.

Posted by: zosima | January 18, 2010 2:19 AM | Report abuse

Right , of course, better and better. Have you noticed that Coakley NEVER says anymore she will go to Washington to make sure this bill passes? She now only speaks in Reagan like stories about it (Mr., I met a quote Casablanca) about fictional couples, like "Jim and Karen" who are having a hard time buying insurance.

Posted by: truck1 | January 18, 2010 8:20 AM | Report abuse

Mr. Klein is very young, and I fear also out-of-touch with the American people. I'm a life-long democrat. I've served from volunteering to a city mgr. in Ted's 1980 pres. bid. Tonight Ezra stated that he doesn't know how else dems should proceed rather than push the HC bill. I'll tell you how, in case you still just don't 'get it'. Mr. Brown won and his main thrust was that he would be the 41st vote against this bill. Get it? This was one of the main issues. Our party should not disregard the will of the majority of the people. We need to respect 'gov. by the people'. The American people have spoken loud and clear. I'll tell you how else we can proceed, we can slow down and pass something meaningful IN THE LIGHT OF DAY. Well start with pre-existing conditions and go from there. It may not fit into our little ideological agenda that we view with blinders on, but let's start fresh and have an open dialog and debate with the people. Most people believe in mal-practice reform (caps), let's start there too. Let's get some real competition in the insurance industry....and regulation. Let's do some things that will genuinely bring down the cost of care. However, more than anything, let's listen to the American people....or we will hear from them in Nov., I promise you. I am a democrat, but I am an American first. Pushing something that the people don't want is wrong, the way we have been doing it is wrong, and the people of Mass. have just let us know that quite, quite clearly. Dr. E.G.

Posted by: cruisedoc | January 20, 2010 12:21 AM | Report abuse

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