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Cutting the red tape: Is the FDA a threat to patient health?

16 August 2012




Widespread drug shortages have been rippling through the United States for more than a decade, but the driest of the drug spells has been seen during the past two years. Dr Nicola Davies questions tightening regulations on generic pharmaceutical manufacturing in the US and asks how drug shortages can be prevented in the future.


Drug shortages in the US have jumped from 56 in 2006 to 250 in 2011 and the Food and Drug Administration (FDA) has noted that the majority of these shortages have been linked to manufacturing shutdowns caused by safety and quality fears.

Placing the blame as drug shortages increase

"Investigations do not seem to have deterred the institution from their bold policy implementations."

With drug shortages steadily increasing, interruptions in treatment as well as higher healthcare costs are now nearing crisis levels.

"This is a huge, growing crisis in this country, where we're actually having to ration drugs," says Dr Wendel Naumann, associate director of Gynaecological Oncology at the Levine Cancer Institute, North Carolina.

In 2011, the manufacturers of generic injectable medications were coming under increasingly heavy fire from the media, as products that had been on the market for years were becoming nearly impossible to keep in stock.

Early reports indicated that drug shortages were being caused by an increased demand, as well as an unlikely shortage of materials. However, information has recently surfaced to reveal that the FDA may have been behind the problem from the start.

Reports are now revealing that the FDA has shutdown nearly a third of the total manufacturing capacity of some of America's largest pharmaceutical producers, including industry giants Bedford, Hospira and Teva.

As many as 58% of the drugs which were either in short supply or completely unavailable this year have now been attributed to FDA policy enforcement. This means that more than 100 different medications have been unavailable to hospitals during the past quarter alone.

Regulatory scrutiny is just one among a host of challenges

Dr Scott Gottlieb, resident Fellow of the American Enterprise Institute, Washington DC, has produced two statements before the Committee on Oversight & Government Reform, and warns that: "In our search for the cause of the shortages, and the pursuit of solutions, we need to be careful not to confuse the consequences of the problems for its root causes."

"Reports are revealing that the FDA has shutdown nearly a third of the total manufacturing capacity of some of America's largest pharmaceutical producers."

Dr Gottlieb believes there are three root causes to the drug shortages: 1) regulatory challenges; 2) pricing and profitability; and 3) market structures that prevent firms branding their products.

In terms of whether the FDA is to blame, Dr Gottlieb comments that: "The regulatory scrutiny isn't the cause of shortages, but another of the multiple factors that have contributed to the conditions challenging these drug makers."

In a move aimed at departure from the blame game, the government has commenced investigations to determine whether the FDA's regulation of drug supplies has been more beneficial or detrimental to the nation's health.

Meanwhile, these investigations do not seem to have deterred the institution from their bold policy implementations.

In July 2012, during the same month in which the Committee on Oversight met to review the actions and consequences of the FDA's strict approach, the FDA turned its all seeing eye on Hospira again.

The company was ordered to recall 19 lots exclusively made up of medications used to treat ovarian, lung and head and neck cancers, which the FDA had earmarked as contaminated.

At the end of June, a report was released stating that despite the drugs being in circulation for nearly seven months, no side-effects attributable to any contamination had been found.

The human cost of drug shortages

"With drug shortages steadily increasing, interruptions in treatment as well as higher healthcare costs are nearing crisis levels."

Dr Gottlieb draws attention back to the fact that real people are currently suffering as a result of these drug shortages.

"The shortages have caused patients to miss or delay chemotherapy or to get inferior antibiotics, anesthetics and intravenous nutrition," says Dr Gottlieb.

"Shortages of drugs have triggered clinical mistakes and bad outcomes in situations where patients received medicines that prescribers weren't accustomed to using."

Dr Michael Link, former president of the American Society of Clinical Oncology, Virginia, adds that while oncology medication can now cure as many as 80% of the most typical cancers in children, the possibility of curing even the least aggressive cancers drops to near zero when treatments are not available.


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Dr Scott Gottlieb, resident Fellow of the American Enterprise Institute, Washington DC.
Leucovorin Calcium - recalled on July 3, 2012.
Introvale - recalled on June 5, 2012.
BENADRYL - recalled on November 15, 2010.
Hydrocodone - recalled on February 5, 2011.
Coumadin - recalled on May 2, 2011.