The new version of the 996-page legislation doesn’t include language from previous versions that would have directed the FDA to issue long-awaited rules on off-label drug promotion.
Older versions gave the agency 18 months to draft guidance on the dissemination of truthful and non-misleading scientific and medical information about a drug or device that is not on the label.
The FDA held a 2-day hearing on it earlier this month. The debate has accelerated with recent court cases upholding the First Amendment rights of pharmaceutical companies and sales representatives.
“Corporations are people, my friend.” Mitt Romney made headlines and stirred controversy with that head-scratching statement in 2011. He was talking about the right of corporations to spend an unlimited amount of money on politics, but the implication was much broader.
It also foreshadowed several major court decisions regarding “corporate personhood” or the legal rights of business entities.
You may remember the Supreme Court using that logic to give Hobby Lobby the right to deny birth control coverage on religious grounds. The decision was controversial, but limited to family-run businesses.
One year later, another major decision largely flew under the radar, but it will have a much bigger impact on public health in America.
The case involved Amarin Pharmaceuticals, a small drug-maker that won the right to market a fish oil pill for unapproved uses, so long as they used truthful and non-misleading statements.
That means pharmaceutical corporations are people, too — with freedom of speech to advertise their medications for certain “off-label” uses that are not approved by the FDA, so long as they tell the truth.
This could be good for some patients. During the FDA hearing, one drug-maker said its leukemia drug was successful in 96% of patients treated “off-label,” but they could not tell patients who might benefit.
Cancer drugs are a good example of off-label uses that work. Viagra is only approved for erectile dysfunction, but it can also enhance sexual performance. Some people use antihistamines to fall asleep. Others use ADHD stimulant drugs to lose weight.
The risk is that drug-makers will use their freedom of speech to double-down on off-label marketing tactics for medications that are dangerous, do not work, or boost wasteful healthcare spending.
These risks are why the FDA has strictly banned drug-makers from advertising drugs off-label. Some of the largest drug-makers in America have paid billions of dollars in fines for off-label marketing.
Yet it was actually small drug-makers who fought the FDA and won. In 2012, courts overturned the criminal conviction of a sales representative for Jazz Pharmaceuticals who encouraged doctors to prescribe the narcolepsy drug Xyrem for depression and fibromyalgia.
The courts ruled that his speech was protected by the 1st Amendment because he used “truthful and non-misleading statements.”
Drug-makers quickly sued the FDA for similar speech protections. In 2015, Amarin Pharmaceuticals won its fish-oil pill lawsuit. Months later, the FDA settled a similar lawsuit with Pacira Pharmaceuticals to market the anesthetic Exparel at any surgical site, rather than just two FDA-approved surgeries.
Source: U.S. News & World Report