FDA Considers Shift Towards More OTC Drugs

As we touched on last month, the FDA is in the process of exploring new ways to make drugs for common conditions available on a wider basis, namely by approving drugs that would otherwise require a prescription for over-the-counter (OTC) distribution under certain conditions.  The agency is seeking input from consumers, pharmacists, members of the health care community, regulated industry, and insurers on the feasibility of the initiative, and what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in an OTC setting.

Some medical experts in the U.S. note the unwillingness of people to take certain medications as prescribed, which in turn has undermined effective treatment of conditions, including high blood pressure.  For instance, the FDA said that about a third of those with high blood pressure stop taking their medication, which can adversely affect their health.  The agency believes that if people with long-term conditions were given more choice over their treatments, adherence to medicines would increase.

OTC drugs are generally less potent than prescriptions drugs and treat short-term conditions like mild pain, the common cold and allergies.  However, making prescription drugs available as OTC creates some risks.  Patients taking more than one drug increase their risk of experiencing harmful side effects.  Currently patients on a multi-drug regimen may be overburdened.  According to a Consumer Healthcare Products Association (CHPA) survey, 92% of Americans believe that OTC medicines are safe and effective.  But deaths due to unintentional drug overdoses have increased roughly five-fold since 1990 and the risk of all adverse reactions, including serious and even life-threatening complications, goes up dramatically with the more drugs taken. 

Combining less potent OTC versions with other non-related OTC and prescription drugs means patients will need to understand complex aspects of their disease, or exactly when to take a drug to ensure safe use.  A typical OTC drug may cause easily recognized symptoms such as a headache or runny nose, and comes with only a factbox or pamphlet.  But taking cholesterol-lowering drugs called statins , for example, require knowledge about a person’s elevated or abnormal levels of fat in the blood, known as lipids.

Communication about adverse events – which are typically higher in prescription medicines – which would usually be spoken about with a doctor.  Thus, the concern that allowing patients to “self-prescribe” separates them from appropriate medical care.  A shift towards an OTC model would need to take this into consideration.  The FDA will also likely have to rework a number of its rules to accommodate an OTC paradigm.  Additionally, the agency has acknowledged that other issues are:

  • liability concerns;
  • disruption of work flow for often overburdened pharmacists; and
  • equipment costs, and questions about health insurance reimbursement.

 What will happen remains to be seen, but we can assure you it will be interesting to see how it unfolds.