Editore"s Note
Tilting at Windmills

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January 16, 2010

WILL BIOLOGICS POLICY PUSH PHRMA AWAY?.... It looks like President Obama has decided to annoy the big pharmaceutical companies in a big way, enough to possibly push PhRMA, which has supported the reform initiative, into the opposition camp.

At issue is the president's support for a specific measure that would shorten the time that expensive biotechnology drugs would be shielded from generic competition.

Any White House intervention would be welcome news to generic pharmaceutical companies, as well as to some consumer groups, insurers and big employers, which have complained that the proposed House and Senate bills would not allow for robust competition. [...]

Both the House and Senate bills would for the first time create rules by which so-called biologic drugs, which are made in living cells, would be subject to copycat competition, saving the health care system billions of dollars over 10 years.

The drugs, which include big sellers like the cancer drug Avastin and the arthritis drug Enbrel, can cost tens of thousands of dollars a year. Biologics are not governed by the Hatch-Waxman Act, which covers generic competition for more conventional drugs made from chemicals, like Prozac or Lipitor. After the patent on a biologic drug expires, competitors may produce similar products, but they are treated by the health care system as if they were entirely new drugs, not substitutes like generics.

To retain incentives for innovation, 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.

The matter appeared settled when the House and Senate passed their versions, but the president personally intervened on this point during this week's negotiations, pushing to make the exclusivity window smaller than the industry wants. For PhRMA, that means fewer profits. For consumers, especially those fighting cancer, it means more competition and lower prices. In other words, Obama is making the final bill even better.

To put it mildly, the drug manufacturers' lobby isn't happy, and is now threatening to pull its support for health care reform. But as Josh Marshall noted, it's a little late in the game: "Everyone's already voted. In both chambers. Perhaps someone could change their position if one of the big ticket compromise issues -- taxes, abortion, exchanges, etc. -- didn't go their way. But here, is the idea that someone is going to change their vote based on a small revision to the number of years of patent protection against generics because Billy Tauzin giving the ceremonial thumbs down? There's not even really time or ambiguity enough to come up with a good cover for changing positions on this basis."

Of course, if voters in Massachusetts decide on Tuesday to kill this once-in-a-generation opportunity to improve a dysfunctional system that punishes millions, it may be a moot point.

Steve Benen 8:30 AM Permalink | Trackbacks | Comments (9)

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I think you may have removed absolutely key context from the Marshall quote -- his concluding sentence "I guess the answer is yes."

It wasn't clear to me either, but my best guess is that Marshall is saying that some of our conscript fathers will flip flop no matter how obvious this makes it that they are bought and paid for by PhRMA.

I think his argument is that, in any normal polity, elected officials can't change their votes on command with no excuse, but we're not in a normal polity are we ?

Posted by: Robert Waldmann on January 16, 2010 at 8:53 AM | PERMALINK

If, IF, Kennedy's seat goes Republican (there's a sentence I never thought I'd write in my lifetime), especially one as hidious and odious as Brown, there's still hope for health care reform.
If Brown wins, and gets seated soon enough to affect the Senate vote, The House can still say "OK" to the existing Senate bill (inadequate, but better than nothing), since it already has 60 votes, and get it to Obama's pen pronto.
I was hoping for some more House measures to be included in the negotiations with the Senate, but I'll take what we have over the the nothing that the future may bring us if we don't do what's necessary and get Obama's signature on the bill.

Posted by: c u n d gulag on January 16, 2010 at 9:01 AM | PERMALINK

"...would provide a brand-name biologic drug with 12 years of protection from competition, even if the drug's patents expire before that.

"Protection from competition"?????

Hmm...seems I've been hearing for decades from any right-winger in sight, and often in a sneeringly dismissive and condescending tone, the almighty power and rightness of "competition" as a way to solve ALL our problems...

Not enough food?...The market will provide..
No health care?,...The market will provide

But, time and again, these assholes only mean the "free market" as a means to rig a system for their own benefit.

Posted by: marty on January 16, 2010 at 10:31 AM | PERMALINK

Just like in '94. The big boys are on board when they see reform as inevitable. They jump ship at the finish line.

Posted by: RZ on January 16, 2010 at 11:20 AM | PERMALINK

Obama should call in one of his young enterprisiing attorneys on staff and give him a simple research task. Find 1000 regulations that are already on the books being ignored and send the list to big Pharma and tell them that strict enforcement is his agenda if health care fails.

Think outside the pill box.

Posted by: Dale on January 16, 2010 at 12:43 PM | PERMALINK

So let's say PhrMA withdraws its support from the bill 2 days before it passes and at a point where it's effectively too late for any Democrats to back out. Why, exactly, would that be a bad thing?

Posted by: mcc on January 16, 2010 at 1:36 PM | PERMALINK

If Big PhRMA withdraws in a snit then, maybe we could go back to the idea of negotiated drug prices? Obama gave in on that, to make the SOBs happy but, if they're gonna cry anyway, they might as well have something *to* cry about...

Posted by: exlibra on January 16, 2010 at 4:18 PM | PERMALINK

To me, the issue of biologics and the protections that BigPharma seek, and that Obama (apparently) wants to modify, is not an issue of politics or policy, but one of necessity. I have been taking biologics for several years (Enbrel, Humira, etc.) and have suffered the slings and arrows of an incredibly expensive drug regimen. Although these drugs have been life-savers for me, their costs are criminal. So many people who cannot now afford them would benefit from generic "competition", helping in at least some small way to force the price of healthcare down. In addition, as a taker of multiple other generic forms of medication (pushed so hard by the formulary vs. non-formulary battles waged by HMOs against their customers) I have not had my other health issues compromised by this same "generic" push. Where do the HMOs stand on the generics- biologics debate? I would think they would love to see a downward push on costs, and that would benefit millions of people who cannot now afford biologic treatment because of the prohibitive cost of the medication.

I understand the political ramifications of this issue, and the overall effect it may have on the larger healthcare debate (I hestitate to call it reform), but on this issue, I am cautiously optimistic about Obama's push to reduce "protections" for producers of biologic drugs. Perhaps it is more easily understood as a corporatist nod to wider competition to the industry itself, but at least its benefits may tumble down to the consumer, who so eagerly (and desperately) awaits cost relief measures to consumers...

Posted by: Chris C on January 17, 2010 at 12:05 PM | PERMALINK

With the clock ticking away and health care reform in question, you would think that the White House and Congress would focus on one of the many areas where the House and Senate bills do not line up. Attempting to change the biosimilars language which has been approved by both the full House and full Senate. -- doesnt make sense and hurts those who need health care reform the most - sick patients. http://trueslant.com/bio/2010/01/15/health-care-reform-negotiations-focus-on-unresolved-issues/

Posted by: Gayle h on January 17, 2010 at 5:00 PM | PERMALINK
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