BARDA: House vs. Senate

Earlier this month, Representative Mike Rogers (R-MI) submitted the House version (H.R.5533) of the `Biodefense and Pandemic Vaccine and Drug Development Act of 2006' (BARDA). The bill was introduced in the Senate by Senator Richard Burr (R-NC) (S.2564). The two bills are essentially the same with the exception of two controversial sections included in the Senate, but not the House version. Section 5: Orphan Drug Market Exclusivity for Countermeasures Products and Section 7: Collaboration and Coordination. The Market Exclusivity section Amends the Federal Food, Drug, and Cosmetic Act to extend the period of market exclusivity from seven years to ten years for certain new drugs, antibiotics, or anti-infective drugs to treat a rare disease or condition caused by a biological agent, toxin, chemical, radiological, or nuclear agent that is deemed by the Secretary to be a material threat to the United States. The Collaboration and Coordination section provides an antitrust exemption for: (1) meetings and consultations held by the Secretary among persons engaged in the development of countermeasures or pandemic or epidemic products; and (2) agreements resulting from such meetings. See the extended entry for the full text of Sections 5 and 7.

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IAEA Secretary General elBaradei Supports Indian-US Nuclear Deal.

In an op-ed in last Wednesday’s Washington Post, IAEA Secretary General Mohammad elBaradei endorsed the US-India nuclear deal without reservation. The Secretary makes several good points but he fails to demonstrate his assertion that the deal will help reach his own objectives.

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Council on Foreign Relations Gets It Wrong on India

The Council on Foreign Relations just released a “Special Report,” U.S.-India Nuclear Cooperation by Michael Levi and Charles Ferguson. Mike and Charles are first rate thinkers but I disagree with almost every aspect of their report. The report is seductively misleading because many of the recommendations make good sense given the presumptions and context of the report. But the presumptions and context are wrong. So first, we need to step back and examine the context. The authors state early on that “…the Bush administration has stirred deep passions and put Congress in the seemingly impossible bind of choosing between approving the deal and damaging nuclear nonproliferation, or rejecting the deal and thereby setting back an important strategic relationship.” [p. 3] This is true, but the problem is with the deal, not the implementation.

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