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I don’t know of any pharmacist who practices in a hospital or health-system who has not felt the impact of current shortages of medications.  This issue has gained national attention, put ASHP and its members in the national spotlight, and has created partnerships among health care interests to address the issue and prevent more harm from occurring.  So, now that we have S. 296, a bill that would address one element of drug shortages, problem solved right?  Not quite, as most of you know and some of you have communicated to me, the elements in S. 296 alone will not solve the problem.  So why did ASHP and other national organizations support the bill and why are we asking our members to ask Congress to support it?

Let’s go back to December 2010.  While at our mid-year meeting we saw a news article about Senator Amy Klobuchar’s (chief sponsor of the bill) interest in addressing shortages.  Upon our return we met with her office and they indicated their intent to draft a bill and we asked if we could be a part of that process based upon our knowledge of the issue and the summit we helped convene last November.  They agreed, but they also indicated their goal of introducing a bill by the end of January.  Given their aggressive timeline, we realized that any bill drafted by her office would likely be limited in scope and not completely vetted by all of the summit participants.  However, we also saw an opportunity to gain Congressional attention to the issue and build upon S. 296 to amend it later on, introduce another shortage bill, or address it in the upcoming PDUFA talks.  Basically, we saw an opportunity, and given the short timeframe decided we could only tackle one or two of the summit recommendations in the bill.  The recommendation we decided to include was the one giving FDA authority to collect information on drug manufacturers to prevent shortages from occurring.  As stated in our letter of support for the bill, we think this is an important first step, but that’s what it is, a first step. 

I think ASHP members should know that we don’t view S. 296 as a catch all end all bill, but rather a solid beginning to a public discussion of how we can prevent drug shortages from occurring in the future and help FDA develop plans for dealing with the causes of shortages, many of which are complex manufacturing processes.  By introducing S. 296, Senator Klobuchar made a statement that this issue must be addressed, and we simply ran with it.  This has enabled ASHP to work with other Congressional offices, as well as the Senate HELP Committee to begin talking about solutions to this problem.  But I also think it’s important for ASHP members to recognize their important role in this process by helping to secure additional cosponsors to the bill and raise this issue’s profile among members of Congress.  You can do this by using the ASHP grassroots action network and submitting your letter at: http://app6.vocusgr.com/WebPublish/controller.aspx?SiteName=ASHP&Definition=Home&XSL=Home&SV_Section=Home.  We know Congress moves slowly and we have a long way to go, we know the legislative process can be an arduous task often compared to making sausage.  But we also know we need to start somewhere, and that somewhere is S. 296.