CHPA believes the regulation of OTC products rightly belongs with the U.S. Food and Drug Administration and that state regulations breaking national uniformity are counterproductive. 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
We in the United States have 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. During recent years, in virtually every state, lawmakers have attempted to establish separate standards different from FDA and different from each other. 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.

CHPA has long urged the federal government to preserve our existing national system of regulation. State-by-state regulation is simply unnecessary. An OTC pain medication safe for people in Michigan is no more or less safe for people in New York.

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.

President Bill Clinton signed into law the Food and Drug Administration Modernization Act of 1997 at a White House ceremony November 21, 1997. The bill contains 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. It passed Congress November 9, 1997 with overwhelming bipartisan backing. Nearly 100 national and state organizations, representing consumers, health professionals, seniors and retailers, supported the national uniformity provisions.