FDA critiques Pain Therapeutics and Durect marketing for unapproved opioids — 4 highlights

Practice Management

The FDA posted a letter on its website critiquing pharmaceutical companies, Pain Therapeutics and Durect, for marketing an experimental drug in such a way customers would believe the drug was FDA approved, according to STAT.

Here are four highlights:

 

1. On the companies' websites, Pain Therapeutic and Durect described the drug as "long-acting" and "tamper-resistant" which may lead users to believe these were "established facts" about the drugs, which the FDA has yet to approve.

 

2. Both websites did not clearly say Remoxy ER lacked FDA approval. Remoxy ER is a form of oxycodone.

 

3. The FDA also claims the websites' designs pose challenges to obtaining the "few references to the experimental status of the drug," STAT reports.

 

4. The FDA has issued nine letters to companies for misleading practices over the past two years. In 2010, the FDA sent 52 such letters to pharmaceutical companies.

 

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