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WASHINGTON, DC – A bipartisan group of U.S. lawmakers introduced legislation today to help lower consumers’ overall health care costs by making more over-the-counter medications available to patients.

The legislation – led by U.S. Reps. Diana DeGette (D-CO), Bob Latta (R-OH), Debbie Dingell (D-MI) and Brett Guthrie (R-KY) – would reform the system that the U.S. Food and Drug Administration currently uses to review and approve new over-the-counter drugs for market, known as the OTC monograph system.

If approved, the measure would help get more safe over-the-counter drugs approved for the market sooner. It would also reduce the time it takes for drug makers to get the approval they need to update and refine existing over-the-counter products, allowing them to make safer and more effective over-the-counter drugs available to consumers sooner.

“Making more over-the-counter medications available to consumers saves them both time and money,” DeGette said. “Not only are the drugs themselves cheaper than prescription medications, but patients can get them without first having to go to a doctor to get a prescription.”

“From cold medicines to cures for your headaches, over-the-counter medicines are in nearly every household across our country,” Latta said. “That means when health care innovation is blocked by government regulations, it’s patients who lose. Our current process for approving over-the-counter products is unnecessarily inefficient, leading to higher prices and fewer choices for. A problem like this rightfully deserves bipartisan solutions, and that’s what we have in the Over-the-Counter Monograph Safety, Innovation, and Reform Act. It’s time for the over-the-counter approval process to be as modern as the innovations being presented to the FDA.”

"Every day, Americans use over-the-counter products they trust are safe to use as directed,” said Dingell. “This bipartisan bill ensures the FDA has the authority and resources they need to make good on this expectation. Over-the-counter medicines can have very serious health effects on those using them and we need to make sure the agency can act quickly if a safety concern is discovered. Patients and consumers will benefit from the improved safety of their products, and industry will get a reliable pathway to bring new, innovative products to the market – such as sunscreen which hasn’t seen a new product approved in over a decade.”

“Every day, there are new innovations in health care and medications. We need to make sure that consumers see that innovation as soon as possible,” said Guthrie. “I want to thank Reps. DeGette, Latta and Dingell for their work to modernize the over the counter monograph so that innovation products can help all Americans at the drug store.”

A study released earlier this year found that, on average, every dollar spent on over-the-counter medicines saves the U.S. health care system $7.20. The savings, according to the report, come from a combination of consumers spending less on lower-priced over-the-counter drugs, as compared to more expensive prescription medicines, and patients self-treating their ailments instead of paying to see a doctor to get a prescription.

According to the study, 90 percent of patients who purchased an over-the-counter drug to treat an ailment would have gone to see a doctor to get a prescription, if it had been necessary.

The FDA established its OTC monograph system in 1972 to review the safety and efficacy of over-the-counter medications before they are made available to consumers.

The decades-old system has come under fire by both lawmakers and administration officials alike, as well as the health care industry and consumer groups, that claim it is too slow to react to changes in the marketplace.

In fact, the head of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, urged lawmakers during a Senate hearing just last week to reform the agency’s OTC monograph system to help save consumers money. Similarly, FDA chief of staff Lauren Silvis told a healthcare industry group in May that, “OTC monograph reform remains a top priority for the agency.”

To make more over-the-counter medications available to consumers faster, the legislation introduced today would, among other things, provide the FDA additional funding to hire more staff dedicated to its OTC-related work. It would also help the agency develop a new electronic infrastructure needed to speed up the agency’s review and approval process for new over-the-counter drugs.

One of the most substantial changes that would be made under the terms of the 96-page bill, however, would be the creation of a new approval pathway for drug makers to use to update an existing OTC product. Under the current system, it can take several years for a company to get the approval it needs to update a product label with new safety information, or add a new ingredient, or make some other important change to one of its drugs.

By creating a new path for drug makers to more quickly refine and improve their current OTC products, the legislation would encourage more innovation of those products and allow the industry to respond more quickly to any future issues that may arise.

A copy of the bill is available here.

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