The regulation of OTC medicines is appropriately the role of the U.S. Food and Drug Administration. State regulations that break national uniformity can add confusion and cost without benefit. CHPA's long-time efforts to achieve a federal legislative resolution to this issue bore fruit in 1997.
The Case for National Regulatory Uniformity For Nonprescription Drugs
The United States has an efficient national marketplace with goods moving freely and efficiently from state to state. An important segment of this dynamic marketplace is the wide variety of nonprescription, over-the-counter (OTC) medicines.
For decades, the Food and Drug Administration (FDA) has kept watch for consumers over the safety, effectiveness and proper labeling of OTC medicines. This national system has stood the test of time.
At the same time, this efficient national market has been continuously threatened by individual states trying to duplicate the job already being done by FDA. Most of those uniformity-breaking proposals have been rejected, but imagine the consequences of "success." The emergence of 50 "mini-FDAs" imposing inconsistent regulations would completely disrupt interstate commerce and create chaos in the national marketplace.
This would impose a tremendous economic burden on consumers without any added health benefit.
National regulation of OTC drugs by FDA is consistent with the concept of federalism – the concept that federal and state governments should each do what they do best for citizens. FDA should do what it does best: maintain a national system for drug effectiveness and safety. States should do that they do best: implement and enforce this national system to protect their citizens from unsafe, ineffective, or improperly labeled medicines.
While there is a great need for regulatory uniformity, there is an equally strong need for flexibility in how to do it. CHPA supports the kind of flexibility that allows states to petition FDA for different standards that are justified by compelling local conditions. Flexibility should also include provision for states to petition FDA to adopt, as a federal standard, any existing or proposed regulation. This should assure that the entire country benefits from ideas originating from any state capital.
States should not, however, confuse national issues with local issues. OTC medicines moving in high volume at low cost through interstate commerce is clearly a national issue requiring national control and uniform regulation.
The Food and Drug Administration Modernization Act of 1997 included a national uniformity provision that prohibits states from adopting laws or regulations concerning OTC medicines that are different from or in addition to those required by FDA.
The landmark legislation received widespread support and passed Congress with overwhelming bipartisan backing. Nearly 100 national and state organizations, representing consumers, health professionals, seniors and retailers, supported the national uniformity provisions.