Hamsher and FDL have no credibility anymore:
I'm exceedingly proud to have legislation I authored many years ago which prohibits lifetime health insurance caps included in the House health care reform bill. This cap affects many breast cancer victims, such as the woman mentioned in Jane Hamsher's HuffPost column, "House Health Care Bill: A Death Sentence for My Fellow Breast Cancer Survivors," effectively cutting off their insurance when they need it most. My legislation outlaws this practice.
Having put so much into these critical issues, I'm quite frankly outraged by the falsehoods and misrepresentations in Ms. Hamsher's column.
My amendment to create a new pathway for approval of 'follow-on' versions of innovative biotechnology products, or 'biosimilars,' will not deny patients access to these miraculous treatments. In fact, my legislation, sponsored by the late Senator Edward Kennedy, will create for the first time in our country's history an FDA approval process for biosimilars to compete with innovative biologics.
Today, no expedited pathway for approval of a follow-on version of a biologic product exists. There are only generic versions of traditional, small-molecule drugs. For biologics, any prospective competitor to a brand-name product would have to go through the same lengthy and expensive approval process and clinical trials as the original manufacturer. As a result, there is very little economic incentive to develop a competitive version of a successful biologic.
Under the legislation that Senator Kennedy and I championed, prospective biosimilar manufacturers would be permitted to use an accelerated approval process and utilize the clinical trials and laboratory data of the innovative product to demonstrate the safety and efficacy of their product. Biotechnology products are highly complex and, unlike traditional chemical drugs, they cannot be precisely duplicated by a second manufacturer. Our amendment would allow these follow-on manufacturers to say, in essence, "my product is close enough to the original product, and the FDA can rely on the innovator's safety and efficacy data to approve my product."
Biotechnology products cost billions of dollars to develop, test and bring to market, and in order to ensure that competitors aren't immediately allowed to free-ride on the costly safety and efficacy data produced by innovators, some period of 'data exclusivity' is necessary to allow some period of time to recoup the investment in developing the drug. Without such a 'data exclusivity' period, there would be no reason to invest in new biologics. We would see the flow of research funds going to traditional pharmaceuticals, medical devices, semiconductors, green technology or other more promising innovations.
The House and Senate health care bills include a data exclusivity period of 12 years, which is the same amount of time that all drugs enjoy on the market under patent protection, which prevents any competition. I believe the 12-year data exclusivity period preserves the existing incentives for investment in these life-saving products.
It's important to note that today there is absolutely no restriction on data exclusivity -- it's effectively infinite. Competitors are never permitted to use the data produced by a brand-name biologic manufacturer. The Kennedy-Eshoo legislation brings this exclusivity down from forever to 12 years, in essence laying the groundwork for the creation of the biosimilar industry, new competition for the biotechnology industry, and reduced prices for patients.
Let me individually address the patently false statements in Ms. Hamsher's post.
Read the whole thing:
http://thehill.com/blogs/congress-blog/healthcare/65647-setting-the-record-straight-on-our-health-care-legislation-rep-anna-eshoo