Last night in the State of the Union Address, President Barak Obama renewed his support for health insurance reform. “As temperatures cool, I want everyone to take another look at this proposal…If you have a better idea, let me know,” he said as Congress laughed. “Don’t walk away from reform. Let’s get it done.”
Whatever. Writing about healthcare reform is like duck hunting in a hurricane. What you see flying by probably isn’t a duck, and the situation changes too rapidly to get a bead on it anyway.
That said, the biosimilars provision of HR 3590, The Patient Protection and Affordable Care Act, however, is likely to stand, either as a provision of healthcare insurance reform or as a separate bill that may be introduced on its own. The reason is simple. FDA and Congress have been trying to develop a framework to develop biosimilars, and this is a good early step in that direction. The provision should have been introduced alone and passed, rather than being bound to this gargantuan pile of paperwork.
Such an action, however, would have been too straightforward. Instead, by incorporating it into a larger piece of legislation, it can be held hostage to further wrangling. Speculation remains that the 12-year period of exclusivity for clinical data may be reduced.
The bill also called for an annual fee on branded drugs and on medical devices. Although widely perceived as a firm deal, some Washington watchers suspect it may be altered in exchange for votes from the anti-business contingent in Congress.
Reportedly, aside from this bill, there also is some quiet talk about adopting access controls to certain therapies and putting direct government price controls in place. Clearly, this is a negotiating tool, and I’ve no notion of whether it will become policy or will be dropped as quietly as it was mentioned. If used, it could skew research towards areas not generally affected by Medicare or Medicaid. Keep your heads up.
NOTE: These views and opinions are my own and do not necessarily reflect the views or policies of the editors or staff of Mary Ann Liebert Inc.