Health Care Reform Negotiations: Focus on Unresolved Issues
With the clock ticking away, one would think that the tough negotiations over health care reform taking place on Capitol Hill and at 1600 Pennsylvania Avenue would focus on some of the 20+ areas where the House and Senate bills don’t line up — employer mandates, a public option, taxes, to name a few.
But Rep. Henry Waxman (D-CA) and some at the White House are taking a different tactic. They are attacking a biosimilars provision where a consensus and legislative solution has already been reached in the Senate and House, one that would encourage life-saving biomedical research while expanding access to powerful biologics, medicines that treat devastating diseases such as Alzheimer’s, HIV/AIDS and cancer. It also preserves existing U.S. jobs and maintains the biotechnology sector’s ability to create high-wage, high-value jobs.
This biosimilars provision happens to be one of the few provisions that is almost identical in both the House and Senate versions of the health care reform bill. It also passed its relevant committees with strong bipartisan support. In fact, Rep. Waxman’s own House Energy and Commerce Committee voted overwhelmingly in favor of the biosimilars provision.
It’s difficult to understand this approach to create discord where the “peaceful” middle ground has already been well established. All while delaying the entire health care reform deliberation process. Via Biologic Drugs May Get Less Protection – Prescriptions Blog – NYTimes.com:
But it could throw another wrench into negotiations. At a time when Congressional leaders are trying to resolve differences in the House and Senate bills, the issue of biotech drugs is one aspect on which both bills agree.
The biosimilars provision is the result of a careful compromise overwhelmingly approved months ago in each Chamber. The provision would, for the first time, give the U.S. Food and Drug Administration (FDA) authority to approve biosimilars, sometimes erroneously called “generic” biologics. Under the provision, generic manufacturers would be required to wait 12 years before piggybacking on an innovator’s data for regulatory approval.
In addition to receiving support in both Chambers and by both parties, the biosimilars provision is supported by universities, patient groups, venture capitalists and economic development groups. Via AP/washingtonpost.com:
On Thursday, 38 patients groups and research universities wrote a letter backing the 12-year period to House Speaker Nancy Pelosi, D-Calif., and Senate Majority Leader Harry Reid, D-Nev., who are among the health bill negotiators. It said 12 years of protection would balance patients' access to the drugs with incentives for companies to develop more of them.
It’s time for Rep. Waxman and the White House to take on the tough issues that are weighing down the health care reform debate – not reopen one of the few issues that has long been resolved.
Post Your Comment
You must be logged in to post a comment
T/S Members
Log in with your True/Slant account.
[...] Greenwood, President and CEO of the Biotechnology Industry Organization (BIO) explains: They are attacking a biosimilars provision where a consensus and legislative solution has [...]
I’d be curious to know the White House’s thinking here. How would it like to change the provision?
Jim – There is just way too much you don’t tell us here for this to be instructive and helpful.
First and foremost, what is the provision you are writing about??? We can glean that it has something to do with biosimilars but we have no idea what it has to do with biosimilars.
Why is the White House and Rep. Waxman “attacking”? Why would Waxman support the provision in his first go round on the House bill and now change his mind? Waxman is no dummy on this topic, so he likely has a reason and you really haven’t told us what it is.
Certainly, if the best argument you can make is that there is so much for Congress to do working through disagreements on the two bills that they shouldn’t waste time on other items where they once agreed, including a provision that you happen to think should remain as is, that is – with all due respect – suspect. At least tell us what the provision says, no?
The difficult differences are well along the way to being resolved and your examples are a bit old. We already know the public option will not be in any final bill so there is not a lot of discussion any more, as you may have noticed.
You’ve got me curious about this now and I really would like to know what it is about. I attempted to research it but could find nothing of substance. Fill us in! I would like to know why you would like the provision to survive – but it would certainly help to know what the provision is that you’re talking about.
Rick, I have been hearing waxman’s name since he was a trainee political hack out this way in california…..this guy is truly a political gangster……with no redeeming value
In response to another comment. See in context »Thanks for your comment, Rick. To start from the beginning, biologics are complex medicines made from living materials and are used to treat serious, debilitating diseases such as cancer, HIV/AIDS and Parkinson’s. In fact, they are so complex that exact copies cannot be made using existing science, which is why biosimilars (sometimes erroneously called biogenerics) are similar to, but not the same as, pioneering biologics.
Currently, there is no pathway for a biosimilar to enter the marketplace. The biosimilars provisions in the health care bills passed by the U.S. House and Senate would change all this, enabling generic manufacturers — for the first time — to put “copycat” biologics into the hands of patients.
This issue has been hotly debated for years in Congress, examining a broad range of critical issues including how to ensure that biosimilars are safe, what biosimilars should be called and how to encourage continued innovation in biotech while expanding competition.
The provisions that passed the House Energy and Commerce Committee and the Senate Health Education Labor and Pensions Committee with strong bipartisan support find a good balance between all the stated goals of the legislation: they expand access to these powerful medicines, increase competition, reduce costs for patients and create incentives for biotech companies to continue their life-saving research.
A regulatory pathway for US Food and Drug Administration approval of biosimilars would enable generic manufacturers to shortcut the costly process innovator companies go through to develop and test a biologic medicine. It can take over a billion dollars and more than 10 years to develop just one biologic. Under the biosimilars provisions, generic manufacturers would have to wait 12 years before piggybacking on an innovator’s proprietary research and clinical testing to gain approval for their product. They can, however, undertake their own research and testing to develop a competing product.
The period of data exclusivity is at the heart of this renewed debate. As I mentioned in my piece, both committees with jurisdiction over this issue, including Rep. Waxman’s own committee, voted in favor of 12 years of exclusivity. Peer-reviewed studies have found that at least 12 years are needed for an innovator company to recoup its investment, which can then be reinvested in new research and development, leading to new treatments and advances.
Reducing the number of years of data exclusivity will have a chilling effect on continued innovation and it will mean job loss for our industry, at a time when unemployment is already too high. Biotechs will be hindered in their ability to continue to innovate and to create more high-paying jobs.
More importantly, though, patients and their families will have to wait longer before seeing biomedical breakthroughs. Patient groups such as the ALS Association, AIDS Institute and Colon Cancer Alliance have all said that 12 years of data exclusivity provides a good balance for patients — they want lowered costs for bologics, but they don’t want those savings to come at the cost of the continued search for new and improved treatments and hopefully, someday, cures.