New Drugs: The Future of Approval & Safety

2010 was a lean year for new drug approvals. The FDA granted permission for only 21 new medications…below both the 2009 and 2008 levels. Some of the most eagerly awaited approvals have been delayed.  Many see the low numbers as a trend

Courtesy of the WSJ

reflecting an increased focus on safety concerns but the FDA states there has been “no systemic change…” in the process of granting approval. Nonetheless, change is most certainly underway when it comes to evaluating safety & effectiveness for proposed and existing medications. 2010  also saw a significant number of drug recalls by the FDA and the agency used its enhanced authority to address issues of labeling and advertising throughout the year as well.

Armed with more legal power through the passage of the FDA Amendments Act (FDAAA) and moving towards improved data management technologies, the agency is targeting changes aimed at improving the drug approval process, responses to adverse events and other key safety segments with its Sentinel Initiative.

The FDA’s Deputy Commissioner Dr. Joshua Sharfstein, (a strong advocate of more stringent safety regulations, who has just recently announced his departure from the Agency) gave a significant update to the House Subcommittee on Health in Spring 2010.

“…FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis system to link and analyze health care data from multiple sources. On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System—a national, integrated, electronic system for monitoring medical product safety. The Sentinel System…will enable FDA to actively gather information about the postmarket safety and performance of its regulated products—a significant step forward from our current, primarily passive safety surveillance systems.   The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012…”

Lofty but achievable goals when the right data management technologies are brought to the task. The challenges are significant but with almost half of the population taking at least one prescription drug the value of transforming the FDA from an agency that reacts to adverse events to one that proactively prevents them cannot be overrated.

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