An attorney for a major pharmaceutical company was charged with obstruction and making false statements, the US Department of Justice announced yesterday. Lauren Stevens of Durham, North Carolina, was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration.
The indictment states that, in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved - or "off-label" - uses.
Although the company and drug involved were not disclosed in the DoJ statement, a spokeswoman for UK-headquartered pharma giant GlaxoSmithKline (LSE: GSK) confirmed Ms Stevens worked as a vice president in the company's legal department, but has since retired. She also said that the drug in question was its antidepressant Wellbutrin SR (bupropion), which it is charged was promoted for weight loss.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze