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Congresswoman Debbie Dingell

Representing the 12th District of Michigan

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House Passes Over-the-Counter Drug Safety Bill

December 20, 2018
Press Release

WASHINGTON, DC – Today, the House of Representatives passed a bipartisan bill to improve the safety of drugs sold over-the-counter. Congresswoman Debbie Dingell (D-MI) led the effort with Representatives Bob Latta (DROH), Diana DeGette (D-CO), Brett Guthrie (R-KY), Anna Eshoo (D-CA), and Susan Brooks (R-IN).

Sixty percent of all medicines sold in the US are over-the-counter, yet the FDA only has 18 full-time employees overseeing that market. The Over-the-Counter Monograph Safety, Innovation, and Reform Act reforms the outdated over-the-counter monograph system. The legislation modernizes the monograph framework and allows new, safe products to come to market more quickly while addressing safety issues. Also, the legislation boosts the FDA’s budget by creating a new user fee program for over-the-counter drugs which will help give FDA the resources they need to oversee the industry and review new, innovative products.

“American’s use over the counter products every day and trust they are safe for use,” said Dingell. “We need to ensure 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. This bill is a win-win. 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.”

The package of health bills passed by the House also includes provisions by Dingell to strengthen and evaluate emergency preparedness procedures for hospitals and long-term care facilities. Dingell wrote the Worst-Case Scenario Hospital Preparedness Act in the aftermath of the 2017 hurricane season, which caused flooding and power outages at hospitals and medical facilities from Florida to Puerto Rico, resulting in public health emergencies and, in some cases, loss of life.

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