Print“Implementation of the president’s executive order must effectively strike a balance between addressing a complex set of rare but nevertheless concerning issues in the manufacturing process while promoting a market environment that fosters accessibility.”
President Barack Obama ordered the U.S. Food and Drug Administration to step up efforts to curb prescription drug shortages and work with government investigators to thwart stockpilers acting to inflate drug costs.
The executive order directs the FDA to expand efforts to speed regulatory reviews of drugs and drug manufacturing sites, as well as to work more closely with pharmaceutical companies to gain adequate advance notice of shortages.
There were 178 drug shortages reported in 2010. Of the 127 shortages studied by the government in 2010-11, 80 percent involved drugs delivered to patients by sterile injection, including oncology drugs, antibiotics, and electrolyte or nutrition drugs.
Despite the order, reporting by manufacturers remains voluntary. The FDA will get additional funding to review drugs in a timely manner through the passage of Prescription Drug User Fee Act V, if Congress approves it in its current form.
Obama acknowledged in his order that the root problems behind the increasingly frequent shortages lie outside of the FDA’s control. But although the shortages involve just a small number of drugs each year, the number of shortages has nearly tripled between 2005 and 2010. Meanwhile, price gouging on some scarce drugs has been discovered, threatening consumer health and safety, and making the shortages “a problem” Obama says “we can’t wait to fix.”
The government criticized drug makers for failing to provide the FDA adequate notice of potential shortages. In one extreme case, the price of a drug to treat leukemia soared to $990 per vial from its typical contract price of about $12 per vial. Such incidents, when spotted by the FDA, will be referred to the Department of Justice for investigation and enforcement under the order.
But while industry representatives support the president’s call for action, they emphasized that there are broader dimensions to the problem. These include economic dynamics that make some scarce drugs financially unattractive to manufacture, and the fact that some drugs are only produced by a limited number of factories making them vulnerable to manufacturing-related supply disruptions.
“The implementation of the president’s executive order must effectively strike a balance between addressing a complex set of rare but nevertheless concerning issues in the manufacturing process while promoting a market environment that fosters accessibility for these needed products,” says John Castellani, president and CEO of the U.S. pharmaceutical industry’s main trade group, Pharmaceutical Research and Manufacturers of America.
Generic manufacturers have already pledged to formalize the process by which potential shortages are reported, not only by manufacturers, but also by others in the supply chain, reports The Generic Pharmaceutical Association. That process could become all-the-more formal if legislation backed by the president that mandates such reporting becomes law.
Passage of new laws to mitigate shortages may be the only solution to the problem, the dimensions of which are, unfortunately, becoming only too well known.
November 04, 2011
http://www.burrillreport.com/article-seeking_to_end_drug_shortages.html
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