Thursday, September 3, 2009

You Can't Blur These Lines - Pfizer and the FDA

Yesterday, Pfizer agreed to pay $2.5 billion in damages related to charges that the firm illegally marketed the drug, Bextra, and other medications. Bextra, which is no longer on the market, was approved by the FDA to treat pain associated with arthritis and menstrual cramps. The case charged Pfizer with instructing "its sales representatives to tell doctors that the drug could be used to treat acute and surgical pain and at doses well above those approved."

When I read the sentence above in the New York Times' article, my first thought was "Wait, it's NOT approved for acute pain?" In college, I had a sales internship with Pfizer and Bextra was one of my products. While I honestly don't remember the exact sales messages, I just remember always thinking that the drug was a rapid pain reliever.

Having spent 3 years in pharma advertising, I know that we would deal with some brutal medical/legal/regulatory reviews to make sure that every message and image was in accordance with FDA guidelines. However, I'm also hip to the fact that companies can't really control what happens in the field.

Pfizer has been nailed 4 times for similar violations since 2002! When you're a global leader, I understand the pressure to try and keep your sales high. But when dealing with healthcare, where do ethics and corporate responsibility come into play? I took a Health Ethics course in college, and there are many decisions that can boggle the mind and the conscious for PHYSICIANS. So, perhaps, certain pharma leaders believe that they too can toe the ethics line and promote (directly or indirectly) off-label marketing practices.

However, I do know that, much like the IRS, the FDA does NOT play that. If you try and blur the lines on them, they will react. Some kind of way...some kind of how. It happens. So, my advice? Just play inside of your approved lane unless you have $2.3 billion to spare and enjoy drawing the ire of the government AND the public during a heated healthcare debate.