U.S. Congress scrutinizes over-the-counter drugs

Nearly everyone agrees that the U.S. Food & Drug Administration’s system for regulating over-the-counter (OTC) drugs is outdated and broken. Now, some members of Congress want to fix it.

The current system, created 45 years ago, prevents innovative products from entering the market rapidly and hampers FDA from addressing safety issues, said witnesses at a Sept. 13 hearing in the U.S. House of Representatives.

OTC products include most medicines, from pain relievers to cough syrup, found on drug store shelves that consumers can buy without a doctor’s prescription. More than 300,000 OTC products are on the U.S. market, with annual sales of $32 billion, according to FDA.

Most OTC products enter the market without FDA reviewing them for safety or efficacy. If a product conforms to a set of government specifications in a document called an OTC monograph, FDA considers it to be generally recognized as safe and effective, and it can be legally sold.

But when FDA discovers a safety issue with an OTC drug on the market, it takes the agency years to resolve the problem. For example, it took FDA seven years to require liver toxicity warnings on acetaminophen, Janet Woodcock, head of FDA’s Center for Drug Evaluation & Research, told the House Energy & Commerce Committee Subcommittee on Health. In 2007, FDA had to rely on industry to voluntarily change the labels on children’s cough and cold medicines when pediatricians raised concerns about appropriate dosages, she said.

FDA also lacks resources to complete all the monographs for each class of OTC drugs in a timely manner, Woodcock said. FDA must go through the cumbersome rule-making process for each group of drugs, such as cough and cold medicines or antacids. Since 1972, FDA has finalized only seven monographs, she told lawmakers, and needs to complete 88 more.

To help speed the process, FDA, drug manufacturers, and public health groups have worked with lawmakers over the past few months on legislation that would allow FDA to collect fees from facilities that manufacture OTC drugs. The money would allow FDA to increase the number of full-time employees reviewing OTC products from 30 to 135, Woodcock testified.

The bipartisan legislation, which was released as a discussion draft before the hearing, would also give FDA the authority to issue administrative orders instead of having to go through the rulemaking process to finalize each OTC monograph.

“The goal is to create a system that is more flexible and more efficient, that reflects scientific innovations, so that patients and consumers have greater access to better and safer OTC drug products,” says Rep. Michael Burgess (R-Texas), chair of the Health Subcommittee.