When the U.S. Food & Drug Administration (FDA) approves a drug, it does so for limited usage. While some drugs may work for other purposes, it is illegal for drug companies to promote their drugs to doctors for non-approved purposes and sidestep the FDA altogether. However, drug companies do just that – and they do it more often than you might think. That practice tends to harm drug consumers more than anyone and many manufacturers are now being sued and fined over pushing off-label drug usage.

Who’s being sued / fined?

According to various news reports, drug companies often think up new uses for drugs whose patents are about to expire. In turn, drug sales representatives will offer doctors perks such as cruises, trips and consulting fees to “push” the use of the drugs for those “new” purposes. So, who’s being sued or fined over these practices?

• Johnson & Johnson fined $4.5M: Johnson & Johnson, through its subsidiaries Janssen Pharmaceutica and ALZA Corporation, was fined nearly $4.5 million in early 2009 for intentionally dispensing incorrect information about its Duragesic patches and anti-psychotic drug Risperdal – even though the FDA had told it to stop doing so several times.
• Eli Lilly pays $1.4B: Eli Lilly agreed to pay $1.4 billion in early 2009 to settle allegations over illegal marketing practices relating to its schizophrenia and bipolar disorder treatment drug, Zyprexa.
• Pfizer pays $894M: Pfizer agreed to pay $894 million in late 2008 to settle multiple lawsuits over alleged illegal marketing practices relating to its painkiller drugs Celebrex and Bextra.

Obama Administration to change FDA practices

The FDA’s practices with regard to off-label drug usage were fairly lax under the Bush Administration according to legal experts. However, the Obama Administration – in cooperation with its new commissioner, Dr. Margaret Hamburg – plans to change the way the FDA interacts with the drug industry when it comes to promoting off-label uses without prior FDA approval.

If you’ve been injured by a drug that may have been administered to you for purposes not approved by the FDA, contact an experienced drug litigation attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.