Blinding FDA Approval

Final Score:

Generic Drug Industry - 1

Consumer Safety - 0

 In a 5-4 Opinion announced this Monday, the Supreme Court ruled that as long as the brand-name version of a drug receives FDA approval, the generic manufacturers of the same treatment cannot be sued for the drug's design defects in state court.

The ruling overturned a $21 million jury award to Karen Bartlett, a New Hampshire woman who suffered severe burns and lost nearly all of her eyesight after she began taking Mutual Pharmaceutical's generic version of Merck's nonsteroidal anti-inflammatory drug, Clinoril (sulindac), for shoulder pain.

Also released on Monday was a study by Public Citizen which found that current FDA regulations "do not adequately allow for generic drug manufacturers to update their labels if new dangers are revealed once a drug is on the market." The study added that there are at least 52 FDA-approved medications that have "required new warnings for serious or life-threatening risks in the last 5 years." Since generics account for 80% of all prescriptions filled last year, Public Citizen urged the FDA to "allow drug producers to report updated safety information." This reporting would ensure warnings are up to date and also correct a disparity in legal rights for consumers.

So now's the time Congress to re-evaluate the protections given to generic drug manufacturers. And they better do it now, or there will be more Karen Bartletts to come.