FDA To Track Illicit Product Trade Online

FDA To Track Illicit Product Trade Online

March 26th, 2013 // 3:00 pm @

April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance

FDA plans to monitor the Internet to ensure that prescription drugs, tobacco and other regulated products aren’t illicitly traded or marketed online.

In procurement documents posted online March 21, the FDA plans to hire a contractor to look for a laundry list of illegal activity involving FDA-regulated products, from prescription drugs for sale online contrary to U.S. law, to the sale of stolen blood. The monitoring would cover websites that sell products, process payments, perform direct marketing or order fulfillment services, and even in some cases merely provide information online.

The monitoring effort is an outgrowth of the work of the FDA’s Office of Criminal Investigation, which investigates a wide array of possible crimes that deal with the distribution of FDA-regulated products, from fraudulent Alzheimer cures to designer drug deals.

According to the procurement documents, the monitoring will include sifting through mounds of publicly available information on websites, online bulletin boards, chat rooms, social networks and even email spam in order to find and report websites that might be engaging in illegal trade or marketing.

Although the FDA will monitor social networks, acting on tips and FDA knowledge and the like, it will not actively participate on any site it monitors as a way to gather more information, the documents said. The contractor might, however, engage in straw purchases online to help the FDA investigate the purchase process and movement of funds in suspected illegal transactions.

Monitoring will be limited to 10,000 websites a year. It’s unclear whether this means 10,000 domains, or merely 10,000 discrete websites.

April 11 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, And 21 Tips and Tricks For Your Next Audit

In earlier documents, the FDA said it planned to use the National Cyber-Forensics & Training Alliance as the contractor, saying that the non-profit cyber investigative and data collection organization is the only one with the capabilities to meet the FDA’s requirements. The group uses a proprietary database and collaborates with law enforcement and industry to help capture data.

The FDA’s monitoring of the Internet for illegal trafficking in regulated substances is only one of the Internet monitoring activities in which the FDA is planning to engage. On another front, the FDA on Saturday awarded a contract to health data collection and analytics company Epidemico to mine social media data to track FDA drug safety efforts.

According to procurement documents, that effort more specifically intends to “assess the usefulness of unstructured social media data mining from a variety of sources in FDA” drug safety efforts, including development of tools and methodologies to make it easier to track health information on social networks.

FDA Compliance Webinars


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner