FDA steps up counterfeit drug investigations

The FDA Office of Criminal Investigations opened 72 cases concerning counterfeit drugs in 2010, a rise of more than 10 percent over the previous year. In fact, the count has risen for each of the last three years, reports Pharmaceutical Commerce, and it's running three to five times higher than a decade ago.

Some recent counterfeiting activity has involved breaches of the so-called normal chain of distribution. The chain, defined by some states in their pedigree rules, was previously thought safe from external, unregulated activity.

"It's time to reconsider how our country can protect its pharmaceutical supply," says Thomas Kubic, CEO of the Pharmaceutical Security Institute, writing in The Hill. He advocates for Congress to take the lead in the global fight against fake drugs in an editorial supporting recent proposals by the Obama administration and congressional members. The proposals cover IP protection recommendations and stiffer penalties for prescription drug theft.

"Even in a divided political environment," writes Kubic, "it's a commonsense public safety step everyone should be able to support."

- read the story
- here's the op-ed

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.