Pew, 8 Other Groups Urge Action on Over-the-Counter Drug Legislation

Speeches and Testimony Read time:
Projects: Health Care Products
Pew, 8 Other Groups Urge Action on Over-the-Counter Drug Legislation

The Pew Charitable Trusts and organizations representing public health advocates, health care providers, and makers of nonprescription drugs and sunscreens praised the reintroduction of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (H.R. 3443) in a June 26 letter to the bill’s sponsors from both parties.

The House bill would streamline the Food and Drug Administration’s regulatory system for over-the-counter products, allowing the agency to act quickly in response to safety concerns or evidence supporting dosage and labeling updates. The bill also would require that makers of these products pay fees to the FDA to ensure that the agency has adequate funds to carry out oversight responsibilities in a timely manner.

In addition to Pew, the letter is signed by the American Academy of Allergy, Asthma & Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products Association; March of Dimes; National Association of County and City Health Officials; Public Access to SunScreens (PASS) Coalition; and the Society for Maternal-Fetal Medicine.

The full letter is included below.

Dear Representatives DeGette, Latta, Dingell, and Guthrie:

We, the undersigned organizations, thank you for your support of public health and for your work on H.R. 3443, the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. As organizations representing public health advocates, health care providers, and manufacturers of nonprescription drugs and sunscreens, we applaud your efforts to modernize the Food and Drug Administration’s (FDA) over-the-counter (OTC) monograph system. As FDA itself acknowledges, the current regulatory system was designed decades ago, and reform is long overdue. Congress must now act to make these reforms a reality.

As demonstrated by the recent finalization of the antiseptic hand wash monograph, 45 years after initial notice of proposed rulemaking, the current framework does not allow FDA to pace with the science in a timely way. This bill would streamline agency oversight, transitioning from the current formal rulemaking process to a more nimble administrative order procedure. Through this change, FDA will be better positioned to take appropriate action in the event of a safety concern and to respond to the latest science with updates in dosage and labeling.

Additionally, the user fees authorized by the bill will provide FDA with needed resources, increasing the agency’s capacity to review OTC ingredient applications, clear the backlog of unfinished monographs, and respond expeditiously if safety concerns emerge. Speeding FDA’s ability to make changes to OTC monographs will encourage product innovation, which will enhance choice and allow patients and consumers to better meet their specific health needs.

Without action on this legislation, FDA will miss out on new resources necessary for timely review and the agency will be forced to continue working under an inefficient regulatory framework that simply cannot keep up with today’s science. A more efficient regulatory structure will enable the agency to better ensure safety and allow manufacturers to bring innovative options to market. Should you have any questions or require additional information, please do not hesitate to contact Sarah Despres at the Pew Charitable Trusts at [email protected] or (202) 540-6601.

Sincerely,

American Academy of Allergy, Asthma & Immunology
American Academy of Pediatrics
American Public Health Association
Consumer Healthcare Products Association
March of Dimes
National Association of County and City Health Officials
Public Access to SunScreens (PASS) Coalition
The Pew Charitable Trusts
Society for Maternal-Fetal Medicine

CC: Chairman Frank Pallone, Jr., Ranking Member Greg Walden

Downloads Pew, 8 Other Groups Urge Action on Over-the-Counter Drug Legislation (PDF)
Downloads Pew, 8 Other Groups Urge Action on Over-the-Counter Drug Legislation (PDF)
America’s Overdose Crisis
America’s Overdose Crisis

America’s Overdose Crisis

Sign up for our five-email course explaining the overdose crisis in America, the state of treatment access, and ways to improve care

Sign up
Quick View
America’s Overdose Crisis

America’s Overdose Crisis

Sign up for our five-email course explaining the overdose crisis in America, the state of treatment access, and ways to improve care

Sign up
Antiseptic hand wash
Article May 14, 2019

FDA Update on Permitted Antiseptic Hand Wash Ingredients Took 45 Years

Quick View
Antiseptic hand wash
Article May 14, 2019

Forty-five years after the Food and Drug Administration (FDA) started to update the agency-approved recipe—called a monograph—for over-the-counter hand sanitizers, it announced in April that it had finished the task. The fact that it took more than four decades illustrates why FDA, along with medical, public health, industry, and consumer interest groups, are calling for legislative reform of the monograph system.

OTC products
OTC products
Fact Sheet March 28, 2017

Regulation of Over-the-Counter Drug Products Should Be Streamlined

Quick View
OTC products
Fact Sheet March 28, 2017

Americans routinely reach for over-the-counter (OTC) drugs to treat a wide variety of ailments. And they have a growing number of choices at their local drugstore: The OTC market now includes more than 300,000 products with annual sales of $32 billion. The items are diverse, ranging from antiperspirants and sunscreens to cough and cold medications and pain relievers.

RELATED
Topics
Health Care U.S. Policy
Projects
Health Care Products
Places
United States

ADDITIONAL RESOURCES

A presentation being given by a businesswoman to a group of participants at a business conference.

Fact Sheet

April 12, 2024 Four Plan Features Can Boost 'Retirement Readiness'
An illustration of a couple holding hands walking away from an outline of houses behind them

Podcast

March 22, 2024 Pathways to Homeownership: Housing in America
A landscape with mountains and clouds. BLM Rule Puts Conservation, Other Land Uses on Equal Footing

MORE FROM PEW

A pair of white and black Adélie penguins standing in the middle of a clump of snow face opposite directions. Seeing Antarctic Change, Scientist Calls for Stronger Action
A shipyard with towers in the foreground, a barge on a river, and a blue sky in the background. Louisiana Primed to Take Helm of Offshore Wind Supply Chain
About a dozen people stand examining large blue bins full of whole fish in a warehouse. Some people are in green clothes, others in blue, and all wear ballcaps. A few hold clipboards. Reducing Risk Strengthens the Seafood Supply Chain
A worker in a seafood market dumps bright orange shrimp from a blue bin onto a bed of ice between a lot of other seafood laid out for sale. Other workers are visible in the background, as are the arms of shoppers placing orders from the other side of the ice bed. Seafood Industry Benefits From Greater Vessel Transparency
Composite image of modern city network communication concept

Learn the Basics of Broadband from Our Limited Series

Sign up for our four-week email course on Broadband Basics
Quick View

How does broadband internet reach our homes, phones, and tablets? What kind of infrastructure connects us all together? What are the major barriers to broadband access for American communities?

Pills illustration
Pills illustration

What Is Antibiotic Resistance—and How Can We Fight It?

Sign up for our four-week email series The Race Against Resistance.
Quick View
Pills illustration

Antibiotic-resistant bacteria, also known as “superbugs,” are a major threat to modern medicine. But how does resistance work, and what can we do to slow the spread? Read personal stories, expert accounts, and more for the answers to those questions in our four-week email series: Slowing Superbugs.