Sens. Roberts, King Introduce Bill to Allow Purchase of Over-the-Counter Drugs Using Health Savings Accounts

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by: Senator Pat Roberts (R - KS)

Washington, D.C. - April 16, 2019 - (The Ponder News) -- U.S. Senators Pat Roberts (R-Kan.) and Angus King (I-Maine) have introduced bipartisan legislation that allows Americans to use their health savings account funds to purchase over-the-counter (OTC) medications. Sens. Johnny Isakson (R- Ga.) and Joe Manchin (D-W. Va.) are also cosponsoring the bill.

“Americans should be able to use their medical savings accounts as they see fit,” said Senator Roberts. “This burdensome provision of Obamacare restricts Americans’ choice and flexibility in how they manage their health care expenses and adds yet another burden on physicians – causing patients to seek more expensive, less convenient, and more time-consuming alternatives.”

“It’s just common sense – over the counter medications should not require a prescription from a primary care provider,” Senator King said. “But under current law, many Americans cannot access the funding they have set aside for health care expenses without signoff from their provider. By giving people more freedom to responsibly manage their health care accounts, we can cut red tape, support hardworking men and women, and strengthen the health care system.”

The legislation, S. 1089, repeals section 9003 of the Patient Protection and Affordable Care Act (PPACA), restoring the ability of those participating in a medical savings account, such as a Flexible Savings Account (FSA) or Health Savings Account (HSA), to use the funds to purchase OTC medications.

Nearly 50 million Americans participate in FSAs and other health savings accounts. The accounts allow individuals to set aside their own money each year on a pre-tax basis to pay for health care expenses, such as co-payments, and other health care expenses not covered by insurance.

A broad coalition of groups support this legislation, including the AARP, America’s Health Insurance Plans, the American Academy of Dermatology Association, the American Association of Family Physicians, the American College of Physicians, the American Dental Association, the American Medical Association, the American Osteopathic Association, the American Society of Association Executives, Anthem, Inc., the Arthritis Foundation, the Associated Builders and Contractors Association, the Asthma and Allergy Foundation of America, the BlueCross BlueShield Association, Consumer Healthcare Products Association, ECFC, the Food Marketing Institute, the National Association of Chain Drug Stores, the National Community Pharmacists Association, the National Federation of Independent Business, the National Grocers Association, the Retail Industry Leaders Association, the Sjögren’s Syndrome Foundation, the U.S. Chamber of Commerce, WageWorks, and Wex Health.

Guthrie Releases Bipartisan Draft Legislation to Reform Over-the-Counter Approval System

Source: House Representative Brett S. Guthrie (R-KY, 2nd)



Washington, D.C. - September 12, 2017 (The Ponder News) -- Congressman Brett Guthrie (KY-02) and a group of bipartisan Members of Congress have released a discussion draft to reform the over-the-counter (OTC) monograph system. The bill was introduced by Rep. Bob Latta (R-OH) along with Energy and Commerce Committee members Rep. Michael Burgess (R-TX), Rep. Gene Green (D-TX), Rep. Diana DeGette (D-CO), and Rep. Debbie Dingell (D-MI).

The draft would modernize the “monograph” framework that allows the FDA to make scientific determinations for OTC ingredients through an administrative order processwith user fees, an approach closer to new drug application procedures. These updates will allow new, safe products to come to market more quickly, rapidly address safety issues, and expand consumer choice.

“As our medical and pharmaceutical technology rapidly advances, we must ensure that the FDA keeps up with innovations in over-the-counter drugs,” said Guthrie.“I was proud to join Rep. Latta and other members of the Energy and Commerce Committee to introduce this bipartisan legislation that will give the FDA more flexibility to help get new medicines to Americans faster.”

“The outdated OTC monograph system stifles innovation and harms consumer confidence,” said Latta.“Moving to a more flexible system that uses new information and scientific advancements ultimately means more certainty for manufacturers and better products for consumers. Working in a bipartisan manner, we’ve released this draft legislation that adds predictability to the monograph process and would create a more robust over-the-counter marketplace.”

“This bipartisan initiative is a victory for patients and consumers,” said Burgess. “The current over-the-counter monograph system is outdated and deters updates and innovations to over-the-counter medications. This bill will allow for meaningful modifications to the monograph that will equip manufacturers to continue to deliver high-quality products to consumers. We must continue to strive to do more to reform approval processes at the FDA and subsequently increase access to care.”

“Americans utilize over-the-counter products dozens of time every day” said Green. “The FDA’s regulatory framework for oversight of most over-the-counter products has not been updated for decades and is widely regarded as flawed. The current system is unable to keep pace with scientific discovery or respond quickly to safety concerns. We have been working in a bipartisan manner with the FDA and stakeholders to create a more flexible, modern process and give the FDA the resources is needs to respond to new drugs and keep patients safe. This draft is the next step in that process, and we will continue to work across the aisle to advance this important issue.“

“Virtually every American uses over-the-counter medications to treat headaches, colds, and other common ailments,” said DeGette. “The market for these products has grown substantially and the science has advanced, but the system for reviewing them remains outdated. It’s virtually impossible for the FDA to respond to safety risks promptly, which needlessly puts consumers in harm’s way. Our bipartisan bill will give the FDA new tools to protect consumers, provide badly-needed resources, and streamline the FDA review process.”

The OTC monograph system was established in 1972 by the Food and Drug Administration (FDA) to review the safety and efficacy of the OTC medicine ingredients then on the market, including doses, formulations, and labeling. Any OTC that conforms to a monograph may be manufactured and sold without an individual product approval. In the 45 years since the system was created, the process has not been completed and movement on unfinished items has been slow. The system has become a hindrance that does not allow for advances in science and new information concerning the safety of an ingredient.

The draft legislation updates the monograph process by specifically adding a new section to the Food, Drug, and Cosmetic Act to:

· Move away from the cumbersome current monograph finalization process to an administrative order procedure. Additional processes will be in place to ensure recourse should issues arise.

· Create new pathways to innovation for monograph products benefitting consumers, where none currently exits.

· Provide standards for determining general recognition of safety and effectiveness for monograph drugs.

· Ensure the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected.

· Include by reference existing OTC Review Final Monographs and deem final Tentative Final Monographs by statute.