Editor’s Note: All this week Check Up will be sharing one new Pharma fact a day that was an important breakthrough in the world of pharmaceuticals in 2012. Today, Check Up delves into Pharma's right to promote drugs.
This month the US 2nd Circuit Court of Appeals (New York, Connecticut, Vermont) decided in a 2-1 vote that a drug rep who promotes one of his/her company's medications for an unapproved use (known as "off-label") is not violating the law. Instead the Court believes the right of drug reps to tout snake oil for cancer without FDA approval is protected under the First Amendment's “freedom of speech.” (See here.)
Pharmaceutical trade groups such as PhRMA are clearly delighted with this ruling because earlier this year, GlaxoSmithKline – long a major presence in the Philadelphia area – paid a $3 billion fine for promoting at least four of their products (Wellbutrin, Paxil, Advair and Lamictal) off-label.
The 2nd Circuit Court's ruling comes under the same heading as the US Supreme Court's Citizens United decision in 2010 that allows corporations to anonymously make unlimited political contributions. Both distort the First Amendment in favor of plutocracy and against popular sovereignty.
In addition to expanding liberty into license for predatory companies, the 2nd Court of Appeals weakens the FDA's power to protect American citizens from the greed of pharmas and their more aggressive sales reps. While sales reps on the whole are no worse than the average in so far as stealthful deception, they work in an environment that places enormous pressure on them to push unceasingly for more prescriptions, just to keep their jobs.
Justice Felix Frankfurter once wrote that some of our most cherished liberties result from cases dealing with the despicable acts of people who aren't very nice. That's certainly true. Cases that developed the modern understanding of the right against self incrimination and protection against unreasonable search and seizure, for example, involved restraining police procedures against people accused of murder and other violent felonies. But the courts in those cases pursued a delicate balancing act of protecting essential liberties while trying not to encourage the substantively harmful behavior of lowlifes. The 2nd Court of Appeals, on the other hand, has displayed the balance of a two-day drunkard by precisely encouraging harmful behavior.
- Dan Hoffman