This seems not to have been commented upon yet in these parts, but it’s an immense blow to health care cost-control efforts, regardless of what system our wise leaders inflict upon us.
Late Monday night, the Senate HELP Committee approved, as part of its health reform bill, an amendment granting 12-year marketing exclusivity on high-tech biologic drugs. This is a massive windfall to pharmaceutical companies, offering extended protection from generic competition for some of the most expensive classes of therapeutic agents.
Biologics are drugs that are grown rather than chemically synthesized — for example, custom-designed proteins harvested from genetically modified cell cultures. They are governed by different rules, and a different branch of the FDA, than traditional pharmaceuticals and include sophisticated and pricey agents in such areas as cancer, autoimmune diseases, and blood disorders. A year’s treatment with the oncology agent Herceptin, for example, can run to $48,000.
Marketing exclusivity is related to, but distinct from, patent protection. A drug or biologic may be protected by various patents that would typically have been taken out years before its approval. Separately, whenever the FDA approves a nonbiologic drug, the clock starts ticking on a period of marketing exclusivity — protection from generic competition regardless of patent status — that typically lasts 5 years.
Biologic agents have not enjoyed marketing exclusivity protection; their makers currently defend their turf exclusively in the realm of patent and intellectual property law. (Note: IANAL.) Recently, the Federal Trade Commission, studying this issue, concluded that no marketing exclusivity was necessary at all for biologics; patent law was sufficient.
Pharmaceutical companies, particularly those with major biologic portfolios and pipelines (eg, Amgen) have of course been lobbying for exclusivity, and our leaders have been listening. President Obama supports a 7-year exclusivity period; Henry Waxman, chair of the House Energy and Commerce Committee, had called for 5 years, comparable to traditional drugs.
Over at the Senate HELP Committee, however (supposedly the good guys in that body, in comparison with Max Baucus’s Finance Committee), Chairman Ted Kennedy was in favor of a 13-year exclusivity, as Tim Noah at Slate noted. Sherrod Brown tried to shrink that golden egg down to the Obama-concordant 7 years, but was voted down 5-17.
Enter our dear friend Kay Hagan (D-NC), who co-sponsored an amendment with Republicans Orrin Hatch and Mike Enzi calling for the 12-year exclusivity period. Monday night it passed 16-7. It’s now part of the Senate HELP Committee’s health reform bill.
Of course, we’ve still got all that horse-trading and sausage-making between House and Senate, and the still-balked Baucus bill, ahead of us. But years of protection from generic (for biologics known as "biosimilar") competition amounts to billions of extra dollars to pharma companies, when the FTC has weighed in saying that not even a single year of marketing exclusivity was necessary.
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Great pick-up!
It goes to show that not only will needed reform never see the light of day under the current Congress, but that said Congress will do all they can to seize the opportunity to enrich the current biomedical regime at the further expense of people’s general health and welfare.
Yes, nice catch!
Healthcare reform should address the following 3 questions:
Will it cover everyone?
Will it bring down healthcare costs?
Will the health of Americans improve in measurable ways?
The current bill is a Rube Goldberg nightmare with giveaways to insurers, BigPharma, and the medical industry. It is difficult to see how costs will be contained. More but not all Americans will be covered but it is unclear if their health will improve because health was never a focus of this bill. And although most industrialized countries have a single payer or variant that works, you have to wonder why all that experience was so blithefully ignored for what Obama has called an American approach.
This one was so super, ralphbon, that I’ve got to tip my cap.
In my case, as you know, you’re preaching not merely to the converted but the borderline civil disobendient.
Indeed, I even disobey the rules of spelling.
ralphbon, thanks very much, recommended.
Don’t you mean “uniquely American”? ;-)
And you’re right, the bill is going to be completely watered down and be complicated and ineffectual in order for Obama to assuage his co-dependent psychosis of trying to appease to the status quo of the economic elitists
Oh, and the fact that it is complicated is going to guarantee that American’s are not going to get anything close to what’s needed
And the bill has a mortal marketing flaw – complication. How are you going to sell it to the 70% (guess) of the American public in middle America that get their info from the teevee and talk radio
Check out the chart
The 24/7 Fox News and radio show talking points are going to be “bureaucracy, red tape, soviet-style regulations, complicated arcane rules, tax increases for the rich which will kill job creation, huge increases in deficit spending, bureaucrats choose who’s covered …”
Good luck fighting that
As opposed to the simplicity of single-payer “everybody in, nobody out.” It’s cheaper; creates jobs; creates tax revenue rather than being a burden; and everybody’s in, rich or poor
But then what do I know?
Indeed, great diary, heartily rec’d.
You forgot: “rationed care” and “won’t get to choose your own doctor” [although I guess they’d include that under “Soviet-style regulations].
Great diary. Thanks.
Ralph, more shock and awe.
Lobby money’s tidal wave once again sinks all taypayer boats.
Thanks for this. I think of the old Mr. Smith Goes to Washington movie. The machines are still so alive and well.
Excuse me, I have to go exercise and eat some veggies. I can’t afford to not be well in this anti-humanity profit-pirate society.