Regulatory Focus™ > News Articles > OIG: Oversight of Drug, Device, Clinical Trial Safety One of Their 'Top Challenges'

OIG: Oversight of Drug, Device, Clinical Trial Safety One of Their 'Top Challenges'

Posted 06 February 2012 | By Alexander Gaffney, RAC 

The Office of the Inspector General (OIG) of the US Department of Health and Human Services is calling the "oversight of the approval, safety and marketing of drugs and devices" one of their "top management and performance challenges" of 2011 in a report released by the agency on 3 February 2012.

The agency compiles a retrospective list of Top Management & Performance Challenges each year to identify what issues are currently challenging the oversight agency. The agency has listed the topic of drug and device oversight as one of its top challenges for each of the preceding four years.

OIG notes that "increased drug and medical device recalls underscore the importance of ensuring the safety and security of the Nation's food supply, human and veterinary drugs, biologics, and medical devices."

According to OIG, the "vast" oversight responsibilities associated with product regulation creates a series of unique challenges. These challenges include the involvement of numerous state and federal agencies, technological advancements in product development, global manufacturing and production, and the growing purview of the US Food and Drug Administration (FDA).

Despite FDA efforts at improvement, including the institution of Risk Evaluation and Mitigation Strategy (REMS) requirements for sponsors of high-risk products and the establishment of numerous foreign offices, "more effort needs to be made to ensure quality and safety" of healthcare products.

In particular, "OIG work found vulnerabilities in FDA's ability to ensure the timeliness of drug application reviews, the adequate monitoring of adverse-event reporting, and the prevention of off-label marketing of drugs, biologics, and medical devices" in their investigation, according to the report.

The use of illegally imported products, unapproved products and off-label products continues to be a challenge for FDA as well. 2011 saw several billion-dollar settlements between drug manufacturers and FDA for the companies' alleged roles in off-label marketing.

Oversight of clinical trials, too, remains a challenge for OIG and FDA. Sponsors are increasingly relying on data obtained from foreign clinical trials, and FDA was only able to inspect 1% of foreign clinical facilities supporting these data. The OIG report noted that this is due in part to "logistical and jurisdictional challenges," but FDA Commissioner Margaret Hamburg noted in Congressional testimony on 1 February that funding limitations are also a huge driver in the lack of trial site inspections.

"These challenges will only be exacerbated with new legislative mandates increasing the Department's oversight responsibilities, such as new authority to regulate the content, marketing, and sale of tobacco products," notes OIG. "Despite making progress and plans for improvement, the Department must make strides in its oversight efforts to meet those challenges.



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