A.S.P.E.N. Call to Action

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) wants you to reach out to your elected officials on the following issues:

Parenteral Nutrition Drug Shortages

May 15, 2012- Drug shortages legislation was introduced as part of the Prescription Drug User Fee Act (PDUFA) reauthorization. A.S.P.E.N. has signed on to multi-organizational letters of support for this legislation. The current bill numbers are S.2516 Title: An original bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes and H.R.5651 Title: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. The full House and Senate are expected to approve a reconciled bill before the current law expires Sept. 30, 2012. The A.S.P.E.N. Public Policy Committee encourages you to write to your legislators to support these bills.

A.S.P.E.N. Endorses Newly Introduced Drug Shortage Prevention Act Legislation

Jan. 31, 2012: U.S. Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced the Drug Shortage Prevention Act to address the scarcity of certain pharmaceutical drugs—and those specific to parenteral nutrition---in the marketplace.

The new legislation (H.R.3839), which A.S.P.E.N. endorses, mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place and it requires the FDA to a use more refined regulatory process that addresses manufacturing problems without instigating drug shortages. Two additional bills, S. 296 entitled “Preserving Access to Life Saving Medications Act” and its companion bill, H.R. 2245 “Preserving Access to Life-Saving Medications Act of 2011” were introduced last year.

A.S.P.E.N. members and constituents are encouraged to contact their legislators to express support for these bills. Together we can really make a difference with this issue. Please take the time to write to your legislator today and spread the word to your colleagues and friends. See more information on contacting your legislator below.

A.S.P.E.N. members have been dealing with Parenteral Nutrition component shortages for well over a year and our leadership recently participated in National Drug Shortage Summit where healthcare leaders deemed the drug shortage problem a national healthcare crisis. In response to this crisis, Senators Amy Klubuchar of Minnesota and Robert Casey of Pennsylvania have introduced a bill S. 296 entitled “Preserving Access to Life Saving Medications Act.” This legislation directs the FDA to address drug shortages by requiring manufacturers to notify the FDA about manufacturing problems or when a drug is to be discontinued. The bill also requires that the FDA maintain an online list of drugs in shortage situations, and revises the agency’s definition of medically necessary. H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 is the companion bill to S. 296. This bill is to amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages. A manufacturer of a drug that is subject to section 503(b)(1) and marketed in interstate commerce shall notify the Secretary of a discontinuance or interruption in the manufacture of such drug.

A.S.P.E.N. members are urged to contact their federal legislators and ask for their cosponsorship of S. 296 and H.R.2245.

To find your Senator or House Representative Contact Information- see below.

To see the full bill visit the Thomas Legislative Information Website and type in S. 296 or H.R. 2245.

A.S.P.E.N. Support Letter Template (See sample letter).

Please send an email letter to your Legislators

Don't know your elected officials? It's simple:

Visit the website: http://www.congress.org.
Enter your 9-digit zip code
Click on the elected official
Click on contact then web form. Insert your letter and submit

Tips for a good letter:

Make it personal - tell them who you are
Make it short
Stay on point - address only one topic
Cite a specific bill - by number if possible
Send the letter by email
Send it to your legislator only - put your home address and zip code in the letter (many legislators will only accept emails from their own constituents)