In a unanimous and bipartisan vote, Arizona’s legislature passed the Free Speech in Medicine Act, which was signed into law about two months ago. Passing anything with bipartisan support is noteworthy in today’s hyper-partisan environment. Passing a bill with such important and positive implications for patients, even if the law is more symbolic than meaningful, is remarkable.
Perhaps even more remarkable, the U.S. Congress now has an opportunity to replicate Arizona’s success at the federal level via the Medical Product Communications Act (H.R.1703, aka the Griffith Bill).
Typically, when the FDA approves a drug, the medicine is approved for a specific condition; and sometimes the approval will be even more specific, such as for a certain sub-population suffering with the condition. Although medicines are approved to treat specific conditions that are listed “on the label”, often these same medicines can help people with other conditions that are not listed on the label. Prescribing medicines that have been approved by the FDA for the conditions not listed on the label is called “off-label” use.
For example, clonidine is an FDA approved medicine that lowers blood pressure, and is, consequently, commonly prescribed to hypertension patients. This is its on-label use. However, clonidine can also benefit patients suffering from cancer pain or migraine headaches. Prescriptions for these uses are considered off-label uses. Similarly, Warfarin’s most common on-label use is for atrial fibrillation. It is also commonly prescribed for hypertensive heart disease, which is an off-label use.
While many patients may be unaware, off-label uses are both common and important. More than 20 percent of total outpatient prescriptions are for off-label uses. For certain conditions, such as for cancer patients, the off-label use of the drugs is particularly important.
Chemotherapy drugs are typically approved for one type of cancer. While the FDA may have approved the drug as effective at targeting only one type of cancer, these drugs will often be effective at targeting the tumors of many different types of cancers. Given the severity of the disease and the ability of FDA approved drugs to help patients suffering from different types of cancers, cancer drugs tend to be used off label more often than many other drugs. In fact,thirty percent of the top-ten cancer drugs in the U.S. were prescribed off-label in 2010.
Using drugs off-label is not without controversy, however, as worries about safety and efficacy have been raised. An important pathway for improving safety and efficacy is through greater communication. And, this is where the benefits from the Medical Product Communications Act becomes relevant.
Currently, pharmaceutical companies are prohibited from communicating with doctors and other medical professionals about off-label uses of FDA approved drugs – their freedom to speak on the potential benefits and side effects of approved drugs is restricted.
This current prohibition on free speech creates a dysfunctional system where off-label drug use is both common and beneficial for patients; but, it is illegal for pharmaceutical companies to speak to the medical professionals who will be prescribing patients their medications about the potential benefits and side effects from off-label use.
Pharmaceutical companies will often have unique, and cutting edge, information regarding the safety and efficacy of off-label uses of medicines. Therefore, prohibiting pharmaceutical companies from communicating with doctors about off-label use could be denying the prescribing doctors cutting edge scientific data. Such information improves doctors’ ability to prescribe the most appropriate medication for their patients.
Furthermore, there is no reason to believe that providing doctors with more scientific data is harmful. Just the opposite. Improving doctors’ access to the latest scientific data would likely improve the safety and efficacy of using a drug off-label, and provides a valuable source of information for doctors on new promising off-label uses for FDA approved drugs.
It is imperative, of course, that these communications are held to the highest standards. When held to these standards, empowering drug manufacturers to communicate truthfully with doctors regarding all the potential uses, benefits, and side effects from FDA approved drugs, as the Medical Product Communications Act will enable, improves overall patient care and health care outcomes.