Cautious Optimism for Passage of Medical Isotope Legislation

Legislation first introduced in 2009 to provide federal assistance for the domestic production of the medical isotope molybdenum-99 (Mo-99) could be enacted as part of the much larger National Defense Authorization Act for FY 2013. This bill is scheduled to go to a conference in the near future before its final passage by the House and Senate.

The American Medical Isotopes Production Act was authored by Rep. Edward Markey (D-MA), and was introduced in July 2009. It responded to two urgent needs: building a domestic supply infrastructure for the production of Mo-99, and moving away from the production of this isotope with highly-enriched uranium. The legislation responded to a 2009 National Research Council report that was mandated by the Energy Policy Act of 2005. Mo-99 is used is more than 16 million nuclear medical procedures in the United States every year, all of which is produced by foreign manufacturers, using highly-enriched uranium in most instances.

While this bill garnered much support on Capitol Hill and from organizations such as the American Association of Physicists in Medicine, an AIP Member Society, it has never moved toward final enactment. It was the subject of a hearing in the fall of 2009, where witnesses testified about the importance of the legislation. This bill, then known as H.R. 3276, was cosponsored by Fred Upton (R-MI), now the chairman of the House Energy and Commerce Committee, who then remarked “we are really at a crisis.” Two months later the House passed this bill by a vote of 400-17, with representatives from both parties voicing their support for the bill. In December, the Senate Energy and Natural Resources Committee held a hearing on the bill. Committee Chairman Jeff Bingaman (D-NM) and Ranking Member Lisa Murkowski (R-AK) both spoke favorably about the legislation. The committee sent the bill to the Senate floor in early 2010.

The Obama Administration was moving on both the diplomatic front and with technical support to encourage the production of Mo-99 with low-enriched uranium. In December 2010, the state-owned Nuclear Energy Corporation of South Africa sent its first shipment of Mo-99 produced with low-enriched uranium to the United States, with assistance provided by the National Nuclear Security Administration.

In November 2011, the Senate took up a new bill, S. 99, also titled the American Medical Isotopes Production Act. New legislation was necessary because the original House bill – H.R. 3276 - had died with the earlier adjournment of Congress. Following Senate passage the bill was sent to the House, where it was referred to three committees for their consideration. No further action has since been taken.

The Administration continued it efforts, announcing in June 2012 six economic and regulatory measures to transition to domestic production of MO-99 without the use of highly-enriched uranium. Last month, NNSA announced a cooperative agreement with a U.S. corporation for Mo-99 production without the use of highly-enriched uranium.

During Senate consideration of the FY 2013 defense authorization legislation on December 3, Bingaman submitted an amendment, with Murkowski, to the bill. The purpose of the amendment is spelled out under the following section:

The next steps for this bill are for differences to be resolved in the House and Senate versions by a conference comprised of members of the defense authorization committees. It is expected that the conference will go quickly, as Members are anxious to achieve final passage of this bill, which must be voted on for a final time by each chamber. A defense authorization bill has been enacted for 51 consecutive years. When this Congress adjourns all bills will die, and have to be reintroduced before the new Congress can consider them.

It is unknown what the final language of the FY 2013 defense authorization bill will be. There is cautious optimism that it will contain the medical isotope language that was first introduced in July 2009.