2011-11-01

ASH Calls for Increased FDA Authority and Resources to Address Drug Shortages

Calling the increase in national drug shortages “a tsunami of medical risk,” ASH Committee on Practice Chair Lawrence A. Solberg Jr., MD, PhD, offered several recommendations on strategies to combat drug shortages during a meeting of the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research.

As a member of the meeting panel, Dr. Solberg provided the Society’s perspective on strategies to both prevent and mitigate drug shortages, including increasing FDA authority under The Preserving Access to Life-Saving Medications Act (S. 296/H.R. 2245), improving FDA communication with stakeholders, examining the impact of current FDA requirements on shortages, developing a national drug registry, and expanding “orphan drug” status to incentivize continuous production of generics. ASH also submitted comments (image of letter below) to a hearing of the Subcommittee on Health and the Environment of the House Energy & Commerce Committee that expand on these recommendations and express the Society’s position that the current situation is unacceptable, and action must be taken now to alleviate critical shortages. ASH was the first organization to call on Congress to address the problem of drug shortages and the need to provide increased authority and resources to FDA.

Read more about ASH’s advocacy efforts related to drug shortages, the latest update on the status of hematologic drug shortages, and resources for physicians at www.hematology.org/drugshortages. ASH’s recommendations to the FDA and Congress are available online at www.hematology.org/Advocacy/Testimony.  

“Super Committee” Works on Deficit Reduction Proposals; Considers Physician Payment Reform 

As this issue of The Hematologist went to press, the Joint Select Committee on Deficit Reduction (commonly referred to as the “Super Committee”) established by The Budget Control Act of 2011 had just begun its work to develop legislation that achieves at least $1.2 trillion in budgetary savings over 10 years.

The Super Committee will meet several times this year and must report a bill with its recommendations by November 23, 2011. The recommendations have to be voted on by the full House and Senate. If the Super Committee or Congress fails to act by December 23, 2011, the bill calls for automatic across-the-board cuts, split 50-50 between defense and non-defense spending, including Medicare.

Because health-related programs were largely spared from cuts in the Budget Control Act, funding for many health-related programs remains at risk. For example, researchers worry about protecting funding for the National Institutes of Health and other federal agencies; and medical schools are concerned about proposals to create savings by severely cutting graduate medical education.

The Super Committee is also considering physician payment reform as part of its recommendations. ASH has contacted the Super Committee and urged it to thwart the scheduled 29.5 percent reduction in 2012 Medicare physician payments and permanently repeal the flawed Medicare payment formula.

To obtain the latest information about the Super Committee’s work and its impact on hematology, please visit the ASH Web site. 

Absent Congressional Action, 30 Percent Medicare Physician Payment Cut Scheduled to Begin January 1 

Physicians are scheduled to receive a 29.5 percent cut from Medicare beginning January 1, 2012, unless Congress takes legislative action to prevent it. ASH strongly opposes the proposed draconian cuts to physicians and has long advocated for repeal of the sustainable growth rate formula and the need for an adequate and stable physician payment system. In recent comments to the Centers for Medicare & Medicaid Services, ASH shared its concerns and urged the agency to actively support legislative efforts to change the payment system. As noted above, ASH also has urged the new “Super Committee” on deficit reduction to include physician payment reform in its deficit reduction plan.

A major barrier to reforming physician payment is the cost of repealing the current payment formula. The Congressional Budget Office (CBO) has priced the cost of a payment overhaul at about $300 billion over 10 years. Complicating the situation further, the Medicare Payment Advisory Committee (MedPAC), an advisory committee to the Congress, is considering a proposal that would pay for the reform by allowing specialists’ payments to be cut while maintaining the rates for primary-care physicians. All other services covered by the physician fee schedule would be

cut by 5.9 percent per year for three years and then frozen. (Subspecialists, including hematologists, are not considered primary-care providers, even when performing that function.) ASH has strongly opposed this approach.

ASH continues to advocate that physicians cannot tolerate a nearly 30 percent pay cut. Please visit the ASH Advocacy Center (www.hematology.org/takeaction) to take action.

Congress Passes Bill to Extend Funding for NIH and Other Federal Programs Through November 18 

After a contentious battle that narrowly averted a government shutdown, Congress passed a short-term continuing resolution (CR) to keep the government operating through the start of the new fiscal year that began October 1. The CR extends funding for federal programs through November 18 at a rate of $1.043 trillion, the amount mandated in the Budget Control Act of 2011, which is nearly $7 billion below the current year. As a result, most federal programs, including the National Institutes of Health (NIH), received a cut in funding for the start of fiscal year (FY) 2012.

After a contentious battle that narrowly averted a government shutdown, Congress passed a short-term continuing resolution (CR) to keep the government operating through the start of the new fiscal year that began October 1. The CR extends funding for federal programs through November 18 at a rate of $1.043 trillion, the amount mandated in the Budget Control Act of 2011, which is nearly $7 billion below the current year. As a result, most federal programs, including the National Institutes of Health (NIH), received a cut in funding for the start of fiscal year (FY) 2012.

The CR allows Congress additional time to complete work on the annual spending bills. However, with the two parties once again locked in a showdown over spending, additional cuts in funding for NIH remain a possibility. All Members of Congress need to hear from their constituents about the need to adequately fund NIH. To contact your Representative and Senators quickly and easily, please use the email template offered online at www.hematology.org/takeaction. The Society encourages you to personalize the letter, providing examples of why NIH funding is important to you and your research.

back to top