While it is not uncommon for pharmaceutical companies to overstate the efficacy of their products and downplay serious side effects, FDA is now taking a strong stance; stronger than just issuing warning letters — a possibility of “stern FDA regulatory action, including seizure or injunction, without further notice.”

This strict warning was recently given to Baxter International, Inc. for its lung drug Aralast because FDA says that Baxter is claiming efficacy levels that are not true, despite having received 2 warning letters regarding this issue already. Now, FDA wants Baxter to not only remove those claims but also to come up with a plan to make sure all its drug promos tell the truth.

While this may not have been pleasant news for Baxter folks, who have very recently had to deal with heparin (imported from China) issues and a Hylenex recall, this is definitely good news for patients and physicians who have had to deal with unforeseen complications that arise out of falsely marketed claims.

It seems that FDA has become more vigilant of drug-marketing materials over the years, as evident by the issuance of 68 warning letters so far this year, which is nearly twice more than 2009 (41) and more than three times greater than 2008 (21).

To read the letter, click here:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224225.htm

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