In America, we have the Food and Drug Administration (F.D.A.) to ensure that the food we buy is safe to eat, and that drugs do for our health what their makers say they do.
A U.S. Court recently tossed much of that premise out the window, saying pharmaceutical companies and their employees can not be prevented from making claims about health effects that are un-verified by the F.D.A. In effect, the decision gives drug makers the green light to make up any claim they please, to make the sale.
You can bet that the salespeople will still trumpet the F.D.A. approval of drugs, even while they may soft-pedal the fact that the approval doesn’t extend to the use for which the drugs may now be marketed.
We’re back to the era of snake-oil salesmen.
If you’re seeing parallels to Citizens United here, you’re not alone.
A recent article from a legal website has more. Here’s an excerpt:
Appeals Court Calls Off-Label Drug Marketing Free Speech, by Irvin Jackson, AboutLawsuits.com, Dec. 7th, 2012
In a decision that could fundamentally change the actions of the pharmaceutical industry in the United States, a federal appeals court has ruled that the government does not have the right to prevent drug company employees from promoting their products for uses that have not been established as safe and effective by the FDA.
A panel of judges from the U.S. Court of Appeals for the Second Circuit issued a ruling (PDF) this week that the FDA was violating the free speech rights of drug companies and their representatives by preventing them from pushing medications for uses that have not been approved by the FDA, which is known as off-label promotions.
Over the last several years, the FDA has received billions of dollars in legal settlements from major drug companies such as Pfizer, Johnson & Johnson, and GlaxoSmithKline due to off-label marketing lawsuits….
While it is legal for doctors to prescribe a drug or use a medical device for any use they deem necessary, it was not considered legal for the manufacturer to suggest it could be used for something other than what the FDA had specifically signed off as safe and effective.
Prohibitions against off-label marketing are designed to protect consumers, preventing them from becoming unwilling test subjects for medications or medical devices that the manufacturers have not adequately studied.
Ruling Could Be ‘Citizens United’ for Pharma Industry
The decision by the Second Circuit panel is already being compared to the controversial U.S. Supreme Court’s Citizens United decision, which granted corporations a freedom of speech that resulted in their ability to throw endless amounts of money at political campaign.
The panel’s ruling that drug manufacturer promotions are protected by the First Amendment right to free speech could, if upheld, result in them being allowed to promote any drug for any purpose they wish and also raises more questions about the FDA’s ability to regulate other forms of drug advertising, such as whether the agency can continue to force the addition of long lists of side effects and warnings.
The decision could have wide-ranging implications even beyond the drug industry, impacting the federal government’s ability to control promotions of everything from cars to cigarettes…