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BY OUR CORRESPONDENT
29 October,2006: United States Food and Drug Administration is keen on working over a new legislation pertaining to the approval of bio-generics or follow-on biologics.
Senator Orin Hatch told the Generic Pharmaceutical Association that the Acting Commissioner for FDA, Dr Andrew von Eschenbach wanted to work with him on the issue.
"Let me be clear, I still have a deep interest in doing something legislatively, probably not this year, but, hopefully, in the next Congress. Let‘s face it; this is a really tough issue, ‘’ Senator Hatch said.
The Senator said he is continuing his discussions with Henry about introducing a bill on bio-similars legislation in the Congress. Even though his friend Henry is all for such a Bill in this Congress itself, Waxman would be more than happy to work with him in the next congress if Henry was willing to do a balanced piece of Legislation. "And you can be darn sure that any future bill that we end up passing together would be called Hatch-Waxman II,’’ he commented.
While acknowledging that it would be difficult to manufacture some generic equivalents of biologics, and that human clinical testing would likely be required, the Senator also noted that biologics are expensive, and so a system needs to be created that will allow a fast-track approval system to reduce costs once patents have expired.
However, Mr Hatch stressed to the GphA that incentives must be balanced for both pioneer and generic drug firms when crafting legislation.
"While I am all for trying to develop a fast track approval system for off-patent biologics, we must protect the intellectual property of the research-based firms,’’ he opined emphasizing the need to determine whether current intellectual property laws for pharmaceutical research and development are sufficient enough to protect and promote large-molecule, small-patient-population medicine in the future.
Mr Hatch also contested the biotechnology industry’s view that the creation of a fast-track approval system was not a good idea and would not be workable. ``And that’s where I start getting frustrated. I believe that instead of people just saying no, the key stakeholders need to engage in constructive discussions to talk about the scientific and legal issues facing follow-on biologics.’’
He pointed out that what he did back along with Waxman in 1984 [in producing the Hatch-Waxman Act] had a good lesson: ``What we need to do today - work together on follow-on biologics and other matters. If we had listened to the naysayers in 1984, [the generic drug] industry wouldn’t be here today.’’
BY OUR PHARMA CORRESPONDENT |
