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The executive order, which is the president’s fifth in a week, directs the Food and Drug Administration to take steps that will “further reduce and prevent drug shortages,” according to administration officials. The order directed the FDA to work with the Department of Justice to increase investigations of price gouging in the pharmaceuticals market, and required regulators to accelerate review of new manufacturing facilities.
Although certain laws already require drug companies to notify the FDA if they plan to stop manufacture of a certain drug, new bills being introduced into the Senate and House would mandate that drug companies notify the FDA of any problem that could cause a drug shortage six months ahead of any supply problems.
According to the White House, there are a small number of drug shortages experienced in the U.S. each year, but the number of shortages has nearly tripled from 2005 to 2010.
The FDA expects 2011 to be a record year for drug shortages The agency’s website reflects that most drugs in short supply are generic intravenous drugs, including antibiotics, cancer drugs, and nutritional supplements. Although it is unclear how many drug shortages will arise in 2011, it is expected to be more than the 178 reported shortages in 2010. Currently, most of the drug shortages are of drugs produced by Teva Pharmaceutical Industries and Hospira, two of the largest manufacturers of generic drugs in the U.S.
According to the FDA’s website, it “cannot require firms to report the reason for shortage or duration of the shortage or any other information about shortages.” However, it said the most common reason for a shortage is that increased demand for a drug surpasses the drug company’s capacity to manufacture.
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In order to keep up with potential shortages, FDA Commissioner Margaret Hamburg said in a conference call Monday that the agency plans to double staff members in its drug shortage office, increasing employee number from five to 11 people.
According to a blog posting from the White House Presidential Office, too many people are forced to wait for prescriptions, switch from the medication they prefer, or go without any medication at all because of nationwide drug shortages.
“We cannot control the factors that cause these drug shortages. But we are committed to doing our part to counteract them. Which is why President Obama signed an Executive Order today that will lead to earlier FDA notification of any impending shortages for certain prescription drugs. Early notification can help prevent a shortage from becoming a crisis by allowing hospitals, doctors and manufacturers to take action to ensure medications remain available,” said the posting.