As influential as the pharmaceutical industry can be, the most influential player in prescription use in the U.S. is still the physician. Since the 1938 Food, Drugs and Cosmetics Act, all but the safest medications require a physician’s prescription. The pharmaceutical industry knows all too well that it is often difficult to change physicians’ prescription writing behavior. Yet, despite this obstacle, the industry pours substantial resources towards this effort.
However, while pharmaceutical companies have been able to successfully influence physicians’ prescriptions, the only way to really take control of prescriptions in the U.S. is by taking the physician completely out of the equation.
Insurers Take Control
Insurance companies learned this and implemented prior authorizations and step-edits, which all but remove the physician from prescription decisions. Pharmacy benefit managers (PBMs) remove products from their formulary if a company didn’t negotiate the right deal. Recently, a large PBM formulary change forced asthmatic and COPD patients whose chronic disease had been well controlled on their current therapy to switch medications. There was little the physician could do to intervene.
Preventing Physician/Pharma Interaction
Even physicians are taking themselves out of the equations. Large physician and hospital practices that are incentivized to increase quality and reduce cost are restricting formularies or not allowing their physician employees to interact with the pharmaceutical industry, which might influence them to prescribe more expensive medications. Ironically, some of these groups are owned and/or managed by physicians.
Another way to take the doctor out of the equation is by making products available over the counter (OTC)—a rare instance where the pharmaceutical industry and the government may have common ground.
Lowering the Cost of Healthcare
If a disease can be managed by a retail pharmacist who dispenses an OTC medication instead of a physician, that lowers costs. Two years ago, the FDA held an advisory board to discuss the possibility of certain chronic diseases such as high cholesterol and asthma being managed in just this way.1 While no definitive decisions have been made, Merck met with the FDA in early May to discuss Singulair availability (for its allergy indication) as an OTC medication.2
Physicians hate no longer having control over clinical decisions. It undermines all the hard work and years of training they underwent to take care of patients. Pharmaceuticals are just one area where physicians have lost autonomy.
There is no question that Merck’s desire to get an OTC indication for Singulair is spurred by the substantial financial hit taken with their product’s loss of patent protection. Virtually overnight, their multi-billion dollar product converted to almost entirely generic prescriptions. However, Merck and other companies who seek to gain OTC status should proceed cautiously. By taking the doctor out of the equation, pharma risks further alienating the people who they have claimed to partner with to treat patients.