Are corporations “people” now? Are they entitled to all the same protections that the Bill of Rights confers on individual citizens like you and me? Should the freedom of pharmaceutical marketing be upheld by laws intended for individuals?
Big pharma companies, for example, often cite the First Amendment (the right to free speech) as a legal protection of their pharmaceutical marketing campaigns. In fact, that’s exactly how pharmaceutical company Amarin won its lawsuit last month against the Food and Drug Administration (FDA).
Off-Label Drug Advertising Is Now Fair Game
Prior to the March ruling, the FDA had prohibited drug companies from marketing off-label uses for FDA-approved drugs, even if the pharmaceutical marketing claims were “truthful and non-misleading.”
The Amarin outcome changed the rules – a pharma company could now theoretically get a drug FDA-approved for one specific use, then market the same drug as a treatment for a variety of other uses as long as the pharmaceutical marketing only uses claims that are truthful.
Marketing Untested Drug Uses
For example, Amarin’s drug Vascepa was originally approved by the FDA for treating patients with very high levels of triglycerides. At the same time, the FDA also considered Vascepa for use in cases of moderately high triglycerides, but only approved it for treatment of very high triglycerides. Until now, doctors could still prescribe Vascepa for moderately high cases, but Amarin could not advertise the drug for that use because Vascepa hadn’t been explicitly approved for it.
Amarin sued the FDA, claiming that its right to free speech was being limited because it couldn’t advertise additional uses for its approved drugs. Amarin won the pharmaceutical marketing suit, but consumers may have lost.
The court ruling in favor of Amarin may seem like a trivial difference to most people, but the case’s implications are far-reaching. According to Dr. Gregory Curfman at Harvard Medical School, it means that “there would be no more motivation for companies to submit their evidence to the FDA for approval of additional indications.”
Off-Label Drug Uses May No Longer Need FDA Approval
Dr. Curfman goes on to explain that new drugs face exhaustive, unbiased review before they are approved by the FDA. A drug company must submit each drug to the FDA to prove that it is safe and effective.
However, as a result of the Amarin ruling, pharmaceutical companies have no holds on them to keep them from encouraging additional or increased use of their already-approved drugs. Quite the contrary, now big pharma companies actually have financial incentive to avoid more FDA testing rounds – and they could start marketing their drugs in ways that mislead or don’t fully warn consumers.
The FDA has just lost some crucial ground in pharmaceutical marketing regulation.
Recent Comments