Health System Reform Insight - March 23, 2012
Given the new direction for the nation's health system, the AMA has developed Health System Reform Insight to help you understand what this new direction means to you and your patients.
Shortages of critically needed drugs hit a record high last year, nearly tripling since 2005, and continue to climb.
As a result of shortages across the country, numerous patient care plans have been delayed or altered. Last July, it was reported that most U.S. hospitals have restricted the use of life-saving chemotherapy drugs and other critical-care medications to cope with the unprecedented shortages. Most of the drugs in question are generic and not highly profitable, and the vast majority are made by only one or two companies.
Late last year, the Obama Administration and Congress held a number of public hearings to identify the extent of the problem, the causes and possible solutions. The AMA and other concerned stakeholders also have participated in meetings hosted by the Food and Drug Administration (FDA).
Because legislative action will not take place until Congress considers the Prescription Drug Users Fee Act Reauthorization (PDUFA) later this year, the Obama Administration issued an executive order directing the FDA and the U.S. Department of Justice (DOJ) to take immediate steps to address elements of the crisis. The executive order requires federal regulators to track drug shortages, quickly approve replacement manufacturing sites and punish price gougers.
The FDA increased the number of staff for its drug shortages program and sent a letter urging drug manufacturers to voluntarily disclose potential prescription drug shortages (even if not required by law). In addition, the Obama Administration released two new reports on the underlying causes of shortages and the FDA's role in preventing them.
The AMA supported these immediate steps to mitigate the impact of, and to avert, looming drug shortages and remains engaged in efforts to address the issue. On the legislative side, the AMA has been working with staff of congressional committees on proposals to address the problem. These proposals will likely be included in the PDUFA, which Congress must reauthorize before Sept. 30 but could consider as early as June.
The AMA sent letters of support for the Preserving Access to Life-Saving Medications Act, which was introduced as H.R. 2245 by Rep. Diana DeGette, D-Colo., and as S. 296 by Sen. Amy Klobuchar, D-Minn. The legislation would require manufacturers to notify the FDA at least six months in advance of any discontinuance or interruption in production of a medically necessary drug. Additional requirements under consideration include the following:
- The DOJ would increase quota limitations on controlled substances to address shortages.
- The FDA would expedite approval of drugs that would mitigate a shortage.
- Manufacturers would develop contingency plans in anticipation of possible future shortages.
Additionally, the AMA and several other stakeholders sent a letter on March 16 to the U.S. Senate Health Education Labor and Pensions Committee and the U.S. House Energy and Commerce Committee, urging immediate legislative action to address the drug shortage crisis.
AMA policy supports legislation that would require manufacturers of FDA-approved drugs to notify the FDA in advance of anticipated shortages, inform the FDA at least six months in advance about plans to discontinue production, immediately report actual shortages, and work with the federal government and key stakeholders to develop strategies to prevent future shortages.
The AMA will continue to work with Congress and the Obama Administration to prevent drug shortages and ensure that physicians and patients have access to medically necessary medications.
AMA members can join AMA President Peter W. Carmel, MD, on his final Office Hours conference call at 7 p.m. Eastern time. Dr. Carmel will give an update on the latest issues affecting the practice of medicine at the outset of the call and then answer questions from participants. Register today.
While the deadline to comply with the Health Insurance Portability and Accountability Act version 5010 electronic transactions was Jan. 1, the agency announced a second extension of the enforcement date, which is now July 1. Physicians who continue to experience difficulties with claims processing should complete a complaint form so the AMA can help resolve these issues and alert CMS to ongoing problems.