John R. Graham | NCPA
Judges are chipping away at government censorship of communications about prescription drugs. The Food and Drug Administration exerts great power over a medicine’s label, which describes the medicine’s therapeutic claims. Drug makers and the FDA sometimes spend years negotiating a label.
The FDA regulates both safety and “efficacy.” So, a drug maker has to prove its medicine works to the FDA before marketing it to doctors. However, the cost of clinical trials to prove claims is monumentally high, so drug makers will not always invest in clinical trials for every indication. Once a drug is used, doctors will find that it is effective for more claims than indicated on the label. The new indications are often supported by peer-reviewed, published research. However, the drug makers have not yet invested the time and money to negotiate with the FDA to get the new claims onto the label. The FDA says drug makers can’t talk about these off-label uses. A federal judge just decided they can.
Oncology is a specialty where so-called off-label prescribing is common. Indeed, off-label prescribing is so common that some states mandate insurers pay for coverage of prescriptions written for off-label use! Clearly, the regulatory bureaucracy is behind the curve on this issue. Nevertheless, the FDA has asserted power to stop pharmaceutical reps from even distributing reprints of peer-reviewed studies supporting off-label uses to doctors.
We are not talking about the cure-all medicine man stopping his covered wagon in town and putting on a show to separate the yokels from their wages. We’re talking about high-level discussions with relevant specialists about new evidence-based medicine.
Fortunately, a judge recently found – on First Amendment grounds – that representatives of Amarin Pharma can distribute such information to doctors despite the FDA’s disapproval.
Established in 1906, the FDA has consistently increased its power. Not until 1962 did it win the power to adjudicate efficacy. Removing that power, and limiting the FDA to regulating safety, would return authority to doctors and patients. The 21st Century Cures Act, which passed the U.S. House of Representatives in June does not go that far. Nevertheless, it allows more “real world” evidence to be added to a drug’s label, which is a step in the right direction.
Source: Health Policy Blog