Law Would Stem Drug Shortages Bucshon's Bill Requires FDA to Police Makers

Article excerpt

WASHINGTON - Shortages of prescription drugs, particularly those designed to aid cancer patients, are reaching a critical stage, and Indiana Eighth District Rep. Larry Bucshon is determined to do something about it. In an unusual act of bipartisanship, at least for the 112th Congress, Bucshon, a Republican from Newburgh, has teamed up with Rep. John Carney, DDel., to sponsor legislation aimed at cutting off potential shortages before they take root.

The legislation, titled the Drug Shortage Prevention Act of 2012, was introduced Jan. 31 and assigned to the House Energy and Commerce Committee and the House Judiciary Committee to study various provisions.

Bucshon, a heart surgeon before winning the Southwestern Indiana congressional seat in 2010, said drug shortages for patients in need of specialized care is a subject of national importance that constitutes "a critical issue that deals directly with the well- being of our citizens."

"It is vital that we are proactive when it comes to preventing shortages and ensuring access to treatments that save lives and improve health," he said. Obama administration officials maintain prescription drug shortages remain relatively rare but acknowledge the problem is growing, particularly as it pertains to unique drugs without good alternatives.

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, reported that the number of drug shortages tripled from 61 in 2005 to 178 in 2010 before hopping up to 230 instances last year. "Some of these shortages delay or deny needed care for patients since they involve critical drugs used to treat cancer, to provide required nutrition or to address other serious conditions," Hamburg said. The picture is actually a bit worse than those numbers make it appear.

In a report issued in October, "A Review of FDA's Approach to Medical Product Shortages," it was revealed the FDA had to step in to prevent 137 additional shortages from Jan. 1, 2010, onward. Drug shortages, the report stated, "have been increasing in frequency and severity in recent years and adversely affecting patient care."

"Some recent shortages have involved drugs for life-threatening conditions and, in some cases, the product in shortage has been the only product for the patient's condition," the report said. "While most drugs do not experience shortages, this is a significant public health problem, one that deserves the concerted attention of government and industry."

Most of the problem comes in the area of sterile injectable drugs. Of 127 cases studied in 2010-2011, according to the FDA, sterile injectables accounted for 80 percent of the shortage.

This carries an impact on the sensitive area of cancer treatment - data indicate the use of sterile injectable cancer treatments has increased by about 20 percent over the past five years without a corresponding increase in production capacity. The major therapeutic classes of drugs facing shortages are oncology drugs, 28 percent, antibiotics, 13 percent, and elect rolyte/nut r it ion drugs, 11 percent. Several factors play into the shortages. "The reasons behind these trends are not hard to find," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.

"Economic forces, industry consolidation, manufacturing challenges such as manufacturing quality, discontinuations, and capacity issues. All are playing into a larger spectrum to cause drug shortages to grow worse and not better." The shortages, Throckmorton said, matter. "They are the injectables," he said. "They are the things that we understand to be most important for public health.

They are things that we need to address or things we need to find a way to turn around. …

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