Comment on FR Doc # 2011-12423

The elimination of all orphan drugs for newly covered entities has a huge impact on the hope for patiients that may be able to experience disease control or even survival as a result of having access to these driugs. It seems unethical for pharmaceutical companies to cease availabilty and/or manufacturing of these drugs; however, the verbiage of the proposed riule could be changed to more simpler terms in that the orphan drugs would be included provided they have marketing approval. Interpretation of the rule is difficult in relation to the impact it will have on clinical trial participants. The exclusion of orphan drugs for certain covered entities, especially in the area of oncology could equate to the elimination of disease control, the elimination for a chance at survival, and hinder progress with research. Thank you for the opportunity to comment on this proposed rule.