NEWS OF THE WEEK
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LTHOUGH MORE than 100 companies supply
the 168 drugs currently in short supply, 51% of these products have only one or two suppliers. That’s one of the findings of an analysis of the supply chain dynamics in the shortfall of critical medicines by the IMS Institute for Healthcare Informatics. The study also finds that 13 companies have stopped supplying drugs in short supply over the past two years. While the total monthly supply of all the drugs involved has increased by 4% over the past five years, IMS found a decline of more than 20% in supply in recent months for 75 drugs. The Food & Drug Administration uses market information to determine whether a drug shortage exists. The drugs in short supply are primarily generic injectable products treating cancer, cardiovascular disease, central nervous system disorders, and other diseases. “Patients throughout the U.S., including hundreds of thousands being treated for cancer, may be at risk of treatment disruption,” says Murray Aitken, executive director of the institute, a division of IMS Health. The pharmaceutical intelligence firm recommends
BID TO REBUFF EPA RULE FAILS AIR POLLUTION: Senate rejects
a move to impede cross-state regulation of emissions
ENATE DEMOCRATS have rejected a measure that sought to block an Environmental Protection Agency rule aimed at reducing air pollution from coal-fired power plant emissions that drift across state borders. The motion to void the EPA rule (S.J. Res. 27), offered by Sen. Rand Paul (R-Ky.), was defeated on Nov. 10 by a vote of 41-56 that fell largely along party lines. The resolution would have nullified EPA’s recently finalized Cross-State Air Pollution Rule. The rule requires 27 states in the eastern part of the U.S. to curb emissions of nitrogen oxides and sulfur dioxide, which contribute to smog and other air quality problems in neighboring states (C&EN, Oct. 17, page 42). “I think we can have a clean environment and jobs,” Paul said during the Senate floor debate. “But not if we let this Administration continue to pass job-killing reg-
S
ulations.” Paul, who represents a major coal-producing state, said the new antipollution rule could cost $100 billion over a decade. But Sen. Barbara Boxer (D-Calif.), chair of the Senate Environment & Public Works Committee, warned that the resolution was “just the tip of the iceberg of the Republican Party’s desire to repeal important health and safety regulations.” Six Republicans voted with Democrats to keep EPA’s rule in place. Sen. Olympia J. Snowe (R-Maine) noted that her state has no coal-fired power plants, but is downwind from other states that do. “The health effects from this cheap energy source are borne by the people of Maine,” she said. “It is unacceptable that these costs are simply transferred from one region to another, and that is why I have strongly supported reducing this pollution with cost-effective technologies.” President Barack Obama had threatened to veto Paul’s measure. The White House Office of Management & Budget issued a statement that said the resolution “would cause substantial harm to public health and undermine our nation’s longstanding commitment to clean up pollution from power plants.” According to EPA, the rule will produce $120 billion to $280 billion in annual health benefits and cost utilities approximately $2.4 billion a year.—GLENN HESS
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COURTESY OF OLYMPIA SNOWE
PHARMACEUTICALS: Study finds significant drop in supply for 75 drugs
that FDA and the drug industry develop an “early warning system” with a supply volatility index, demand forecasting, and risk identification mechanisms. In an Oct. 31 report, however, FDA said many of the “root causes and potential solutions” to the shortage PINCH POINTS Many therapeutic areas lie beyond its purview. “The have been affected by drug shortages. agency is also limited in its current authorities as it forOncology 16% Othera mulates a response to the 28% problem,” the agency said. President Barack Obama Anti-infectives 15% signed an executive order last month that more than Cardiovascular Vitamins & doubles FDA staff devoted 12% minerals 9% to drug shortages and puts Central nervous Pain system pressure on drugmakers 9% 11% to notify the agency of anNumber of drugs in short supply = 168 ticipated supply problems (C&EN, Nov. 7, page 10). NOTE: a Includes digestion, anticlotting, hormones, autoimmune diseases, ulcer treatment, allergy/cough/ The order does not include cold/flu, asthma, dermatology, immunosuppression, and mandatory reporting. reproductive health. SOURCE: IMS Health Harry M. Lever, medical director of the hypertrophic cardiomyopathy clinic at the Cleveland Clinic, told C&EN at a conference on drug safety earlier this year that shortages have become a near crisis. “It’s bad enough that at the clinic we’ve hired a pharmacist whose job it is strictly to keep up with drug shortages,” he said. “I never used to worry about it. Now it’s a major problem.”—RICK MULLIN
Snowe COURTESY OF RAND PAUL
ASSESSING THE DRUG SHORTAGE
Paul
