Reuters: Regulatory News: House report blames strict FDA for US drug scarcity

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House report blames strict FDA for US drug scarcity Jun 15th 2012, 20:03 Fri Jun 15, 2012 4:03pm EDT * Republican-led committee blames FDA inspections for plant shutdowns * FDA enforcing rules without thinking of supply disruptions * FDA says companies must address quality issues like bacteria, glass shards By Anna Yukhananov WASHINGTON, June 15 (Reuters) - Overly stringent enforcement by health regulators has caused the majority of drug shortages in the United States, according to a new report from a Republican-led House of Representatives committee. The House Committee on Oversight and Government Reform said U.S. Food and Drug Administration inspections have forced four top generic drugmakers to shut down 30 percent of their manufacturing capacity, throwing the nation's drug supply into disarray. Responding to the report, the FDA said preventing drug shortages is a "top priority," and that it works with companies to address serious quality issues and minimize supply disruptions. The scarcity of drugs for anesthesia, cancer, nutrition and other conditions has escalated in recent years, jumping from 56 medicines listed in short supply at some point in 2006, to 250 last year, according to FDA figures. Most of these shortages have been of generic drugs that are injectable, making them generally more complicated to manufacture than pills. Darrell Issa, a Republican from California and chairman of the committee that produced the report, said the FDA did not consider supply issues when asking companies such as Teva Pharmaceutical Industries and Hospira Inc to fix problems at their facilities. Hospira, Teva Pharmaceuticals, Sandoz (the generics division of Novartis AG ), and Bedford Laboratories which is part of German drugmaker Boehringer Ingelheim, were cited as the generic drugmakers according to the report. He also said the shortage crisis coincided with the appointment of a new FDA commissioner, Margaret Hamburg, who took office in 2009 and made inspections a priority. Hamburg is an appointee of President Barack Obama, a Democrat. "This shortage appears to be a direct result of over aggressive and excessive regulatory action," Issa said in a statement. "These drugs can save lives and keep people who need them living healthy lives. The FDA is failing to ensure the availability of quality products." The report found 58 percent of the 219 drugs currently in shortage were produced by facilities forced to shut down to fix problems identified by the FDA. The shortage list is from the American Society of Health System Pharmacists. Issa said none of the shutdowns over the past two years were tied to reports about drugs harming people. The effect of drug shortages has been felt in hospitals around the country, forcing them to count pills, beg neighboring hospitals for extra supplies, hoard products or buy from unknown and potentially unsafe sources in the so-called "gray market." But the causes of drug scarcity are wide-reaching. Most experts say drug shortages come from a confluence of factors, including manufacturing problems that have forced multiple companies to simultaneously shut down plants or production lines, eroding profit margins for generic drugs, and industry consolidation that has left fewer companies to step in when something goes wrong. Erica Jefferson, FDA spokeswoman, said companies must comply with laws and regulations to ensure products are safe, effective and of high quality. "We recognize that the problem of drug shortages is complex and stems from an interconnected series of factors," she said. "However, manufacturing and quality problems continue to account for the majority of current shortages." The FDA has pointed to serious quality issues like bacteria or glass shards in vials that companies must fix before they can continue to make drugs. Erin Fox, director of the drug information service at the University of Utah who has been tracking drug shortages, said the FDA may have become more strict in enforcing quality control after the scandal with tainted batches of the blood thinner heparin that killed more than 80 people in 2007 and 2008. "Certainly, FDA has very likely made it hard for these companies to comply," she said. "But on the other hand, FDA is finding scary things. I wouldn't want my loved ones to have drugs that are contaminated with bacteria injected into their veins, or with glass shards. "I was surprised (the report) wants to lay so much of the blame on the FDA without mentioning the very severe quality issues found by them." Link this Share this Digg this Email Reprints

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