2011 Food, Drug and Medical Devices in Review

Drug Shortages

Hospitals in 2011 reported the worst shortage in nearly a decade of chemotherapy agents, such as doxorubicin, as well as drugs for heart patients, some antibiotics and intravenous drugs. Limited manufacturing, lagging production time and low profits contributed to the pronounced drug shortages.

In October, President Obama signed an Executive Order to highlight the administration’s stance on the shortage of lifesaving hospital medications. The new order instructs the FDA to broaden reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages and examine whether potential shortages have led to price gouging. Whether the order has an impact in 2012 and beyond remains to be seen.

Tainted fruit

A listeria outbreak in cantaloupe killed 29 people and sickened nearly 150 in the United States, making it the worst foodborne illness outbreak in the United States, measured by the number of deaths, since the Centers for Disease Control and Prevention began tracking outbreaks in the 1970s.  The outbreak was first detected in September and traced back to a Colorado farm.  Unsanitary conditions at the farm’s packing facility are a possible contributing cause, the Food and Drug Administration (FDA) said in October.

The farm had passed a food safety audit by an outside contractor just days before the outbreak began.  Although FDA officials did not criticize the auditor directly, the agency at the time noted that it intended to establish standards for how auditors should be trained, as well as how audits should be conducted.  The food industry increasingly relies on third-party audits of farms or processing plants to ensure the safety of food.  But the auditors are hired by the companies being inspected, and their procedures are largely unregulated. In several recent food safety lapses, the facilities involved had passed third-party audits.

Food Safety

The Food Safety Modernization Act passed by Congress in 2010 continued in 2011 with “renewed” focus of the FDA on addressing food safety in the U.S.  The FDA began to implement detailed work  to fulfill mandates under the new law.  The agency has specific time frames in which it must establish regulations, issue guidance documents, and undertake studies.  Recently, the FDA noted its continuing work with the Canadian Food Inspection Agency (CFIA) and Health Canada officials to strategize, prioritize, and exchange ideas on joint cooperation to strengthen pubic health goals between the two countries.

Device Regulation Uncertainty
This past year, the FDA announced that it planned to changes to its 510(k) medical device clearance program.  As the FDA and medical devices industry sought to deflect the lengthier approval timelines upon each other, the Institute of Medicine released a report recommending wholesale changes to the 510(k) program.  All of this unfolded prior to the contentious debates on the possible reauthorization of medical devices user fees beyond 2012.