2012-02-16

Important ASH Drug Update: Availability of Methotrexate
As you are aware, the country is experiencing a severe shortage of methotrexate. ASH has been working hard to address the shortage and ensure that hematologists and patients have access to this therapy as soon as possible. This morning, Bedford Laboratories announced that it has limited quantities available of methotrexate preservative-free 1 gram lyophilized powder for injection (NDC 55390-0143-01) and 250 mg/10 ml (NDC 55390-0034-10) with short expiry. The product will be allocated to practices and hospitals starting today. Earlier today, the Society notified all U.S. members with detailed information ASH has obtained concerning how to order supplies of methotrexate.

Please visit the ASH Drug Update page for more details about this and other drug shortages. Also visit the ASH Website to see the comments ASH submitted today to the Food and Drug Administration (FDA) in response to its Interim Final Rule that will help prevent prescription drug shortages.

President Obama Submits FY 2013 Budget Proposal to Congress; Seeks Level Funding for NIH
President Obama has released the details of his fiscal year (FY) 2013 budget proposal. While noting the importance of biomedical research to "improving the health of the American people as well as the economy," the President's proposed budget provides $30.7 billion for the National Institutes of Health (NIH), the same amount provided for NIH in the final FY 2012 budget passed by Congress in December. NIH also faces an estimated eight percent cut as part of the across-the-board cuts that will be applied to federal agencies in 2013. Read more.

Agreement Reached to Avert Cuts in Medicare Physician Payment for Remainder of 2012
Congressional negotiators have reached agreement on extending the payroll tax holiday, unemployment insurance benefits, and current Medicare physician payment rates for the next 10 months, through the end of 2012. In lieu of the 27.4 percent physician payment cut scheduled to take effect on March 1, a payment freeze will be effective through the end of the year. Read more.

New House Drug Shortage Bill Focuses on FDA Reforms
Bipartisan legislation introduced in the House of Representatives on January 31 would expedite FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration quotas for medications in short supply. The newly introduced legislation is intended to be part of the conversation around possible broader solutions to the drug shortage problem that could include bills that have already been introduced in the House and Senate (S. 296/H.R.2245, the Preserving Access to Life-Saving Medications Act) mandating early notification by manufacturers of drugs in short supply. Read more.

ASH Releases Policy Statement on Sickle Cell Trait Screening and Athletic Participation, Recommends Universal Preventive Interventions and Additional Research
ASH released a policy statement opposing mandatory screening of athletes for sickle cell trait as a prerequisite to athletic participation and urging athletics programs to adopt universal interventions in their training programs to protect all athletes from exertion-related illness and death. ASH's position provides a different approach than a policy enacted in 2010 by the National Collegiate Athletic Association (NCAA) requiring Division I institutions to perform sickle cell testing for all incoming student athletes. Read more.

ASH Responds to RFI on Upcoming NIH-FDA Pluripotent Stem Cell Workshop
ASH submitted comments in response to a Request for Information (RFI) on "Scientific and Regulatory Issues to be Explored at an Upcoming Pluripotent Stem Cell Workshop Involving NIH and FDA." In its comments, the Society noted its support for the increased coordination between the research and regulatory communities to enable more effective translation of regenerative medicine and pluripotent stem cell technology into clinical utility. ASH also recommended that NIH review and improve its current funding mechanisms for regenerative medicine research to ensure that resources adequately meet the needs of basic discovery, translational and clinical applications of this evolving technology. Read more.

NIH Issues Guidance on Implementing Reduced Salary Cap
The NIH has issued a guidance notice related to the salary cap enacted as part of the Fiscal Year (FY) 2012 Consolidated Appropriations Act. The law reduced the salary cap on NIH extramural awards from Executive Level I ($199,700) to Executive Level II ($179,700). Additional details may be found on the NIH website.

NIH Launches New Clinical Trials Website for the Public and Health Care Providers
The NIH has created a new website, NIH Clinical Research Trials and You, to help people learn more about clinical trials, why they matter, and how to participate. The website provides patients with information about the basics of clinical trial participation, first hand experiences from actual clinical trial volunteers, explanations from researchers, and links on how to search for a trial or enroll in a research matching program. In addition, health care professionals can read about evidence-based strategies for talking with patients about trials, print audience-tested posters to help promote trials in clinics and offices, and find other educational materials. Additional information can be found on the NIH website at: http://www.nih.gov/health/clinicaltrials/.