It's time to raise Cain about one of the best remaining portions of the Health Care Reform bill: Senator Brown's proposed Amendment for 7, rather than 12 years for life-saving and costly biologic drugs.
At present, Rep. Eshoo argues that her 12-year data exclusivity is better than the infinite data exclusivity currently existent. That seems accurate. But can we do better? When the FTC reviewed the issue of biologics, their non-partisan assessment was that this was more than enough time to permit research and development. Well, we've discussed the Eshoo Amendment ad nauseum. It's time to support what the White House (along with PIRG, the FTC, and the AARP) itself supported: a 7-year limit on these type of drugs, to make them more available and affordable, while also giving them time for safe, adequate research. It's time to keep for-profit PhRMA in line, and acting on behalf of people over profits.
If you want to show your concern for HIV and Cancer patients, as well as all others who take these costly and lifesaving medications, please follow me below the fold to support the Brown 7-year data exclusivity amendment for biologics.
To quickly recap: the issue of this Amendment has been called a life, or death, issue by those on multiple sides of the health care debate.
For some back story, please refer to my last diary, where we considered Rep. Eshoo's Amendment. To summarize, for those who don't want THAT much back story, the Eshoo Amendment proposes that we shorten the infinite monopoly currently existing on the data exclusivity of biologic medications.
A mouthful, and a real mindfuck as well.
It seems like such a good Amendment. It has such good endorsements, like Howard Dean and the Candlight Children's Cancer Foundation. Rep. Eshoo has a great track record with women's health issues, as well. And it is a fine Amendment overall; undeniably better than what is currently in place. But we can do better for the ill.
Update: h/t to slinkerwink for pointing out that Rep. Eshoo's bill has just made it into the GOP version of the HCR bill. One more reason to really consider backing a more Democratic biologic Amendment, such as Sen. Brown's.
So, as long as we're fighting, let's fight for Senator Brown's version of fair:
"Health reform is about lowering costs and improving medical care. Today, we missed a historic opportunity to achieve these goals. The amendment adopted by the committee is not in the best interests of patients or taxpayers -- the big winner here is the drug industry.
"As health reform legislation moves through Congress, I will continue to fight for more competition and cheaper biologic drugs for patients who need them. Drug companies should be able to recoup their research and development costs, but they are not entitled to open-ended monopolies and unlimited windfall profits. The millions of people who depend on biologic drugs, and the millions more stuck paying ever higher insurance premiums, deserve better."
Biologic drugs, which treat conditions such as cancer, Parkinson’s, diabetes, rheumatoid arthritis, Alzheimer’s, and multiple sclerosis, are expected to make up 50 percent of the pharmaceutical marketplace by 2020, if not sooner. Despite this, there is no approval process for most generic biologics, leading to endless monopolies that can cause high prices and can stifle innovation.
Brown’s amendment, which was endorsed by AARP, would have created an approval process for more affordable, generic biologics while allowing drug makers a generous 7-year period of market exclusivity. The amendment that passed tonight would permit 12 years of market exclusivity, despite the fact that the Federal Trade Commission (FTC) has stated that exclusivity periods longer than 12 years would actually discourage innovation by making the continuous development of new products less important to the profitability of biologics manufacturers.
And ultimately, when I contacted Rep. Eshoo, I did not receive a reply explaining a rational basis for why she had suggested 12 years, rather than 11, rather than 7, etc...
I wrote:
Dear Rep. Eshoo,
Recently, I reported about your recent Huffington Post op-ed, responding to Jane Hamsher. I did so on the Daily Kos, a popular Democratic blog site. Here is a link to the blog I wrote: http://www.dailykos.com/...
As a former cancer patient who lives just North, I was deeply concerned by both your, and Ms. Hamsher's, assertions that your amendment involved the lives and deaths of those like myself.
I'm writing to you because I'm still trying to understand one point in the Amendment that you've proposed. I'd like to understand it so that I can relay it to the same people with whom I began a dialog suggesting that perhaps you were attempting to help people, given your exemplary record involving women with cancer, which I've had myself.
The question of "Why 12 years?" has come up again and again, and has not been entirely clear for many, even some who work in biotechnology. Many are wondering why you've chosen this many years, rather than the 7 years that apparently the White House recommended, or the 5 years recommended by Rep. Waxman. As I understand, you felt that 12-years is an appropriate amount of time to provide competitive incentives to pharmaceutical firms to create biologics/biosimilars rather than (as you said) "rogaine" or "viagra," which you've suggested would be a quicker cash cow for a pharmaceutical company to milk.
But the exact reason for the 12 years is in hot dispute, even for those who have otherwise stated support for your amendment. Few seem to understand 12, rather than 11, rather than 10 years.
I strongly appreciate your attempt to stop the infinite data exclusivity currently in place for these pharmaceuticals, some of which I've taken.
Still, it would be incredibly helpful for a bit more understanding about why 12 years. Many who read my blog stated that they were constituents in your district and thought you had a good track record. I personally live just a district or two over.
I realize (from Hamsher's reporting) there was a protest in front of your local office and a xerox was given out. I'm really trying to find an answer to just this one, specific question so that Democrats to whom I'm speaking might understand that this figure was arrived at through some logical calculus and not because you're "doing the bidding of pharmaceutical companies." Many genuinely would like more explanation than provided in your op-ed.
Thank you greatly for your response.
I realize I'm not in your district, but my voice reaches many who are. I'd like to be able to provide them with something concrete, since many seem to approve highly of you.
Most respectfully,
Mrs. __
You may also want to simply address this small point of the "12 years" vs. "5 years" (or however many years) confusion in another op-ed on the Huffington Post, or perhaps on the Daily Kos. That would equally be appreciated.
Nope. No reply. Crickets, even...
Since then, we've had some excellent diaries looking deeper down this rabbit hole.
But I'd suggest this is a much more complex issue than one would ever imagine on first glance. Which is why I appreciate the FTC report (which refers to the Hatch-Waxman Act, which you're welcome to Google if you want that much brain-twisting -- I am personally quite exhausted by the machinations my synapses have been through recently trying to parse through the Byzantine raisons d'etre behind these freakin' Amendments):
Pioneer biologic manufacturers nevertheless have suggested that Congress institute a period of 12 to 14 years of branded exclusivity that would begin once a pioneer biologic was approved by the FDA. During this period, the FDA would be prohibited from approving an FOB product that would compete with the pioneer biologic drug. This branded exclusivity would be in addition to, and would run concurrent with, a biologic drug’s existing patent protection. The economic model put forth by pioneer drug manufacturers to justify this period is based on the average time required to recoup the investment to develop and commercialize atypical biologic drug (referred to as the "Nature model").
Congress has implemented exclusivity provisions in the past to encourage the development of new and innovative drug products when the drug molecule is in the public domain, and therefore not patentable... Central to each of these exclusivities is a public policy trade-off: a restriction on competition is provided in return for the development of a new drug product or new use of an existing product.
A 12- to 14-year exclusivity period departs sharply from this basic trade-off, because it does not spur the creation of a new biologic drug or indication. The drug has already been incentivized through patent protection and market-based pricing. The potential harm posed by such a period is that firms will direct scarce R&D dollars toward developing low-risk clinical and safety data for drug products with proven mechanisms of action rather than toward new inventions to address unmet medical needs. Thus, a new 12- to 14-year exclusivity period imperils the efficiency benefits of a FOB approval process in the first place, and it risks over-investment in well-tilled areas.
Don't worry if this is all Aramaic to you: I'm slow to draw conclusions, personally and have thought this through a great deal.
At this point, it appears that the Brown Amendment is one of the best parts of an otherwise tepid public option. The Eshoo Amendment is probably an alright deal, but why not go with the White House's choice? It's viable, and it will save five more years of human life than the Eshoo Amendment. And raise your hand if you like President Obama watching out for cancer patients, when his own mother died while fighting with the insurance companies over her treatments. But even if you're not a big Barack fan, the broad support for Sen. Brown's bill, and the logic behind is, is quite impressive.
Before emailing your support for a 7-year-maximum wait time for biologic generics (and practicing your tongue twisters too), remember that the most vulnerable populations here are children with cancer, people with HIV, and women at risk for breast cancer.
Bless up!
Sherrod Brown's Email
Senator Chuck Schumer (D-NY): 202-224-6542
Senator Susan Collins (R-ME): 202-224-2523
Senator Sherrod Brown (D-OH): 202-224-2315
Senator Debbie Stabenow (D-MI): 202-224-4822
Senator David Vitter (R-LA): 202-224-4623
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And please, let me know if I've misreported any of this, or you still feel strongly about alternate bills, because I appreciate your insight and would rather hear from you than stand on a soapbox shouting to a crowd of one.