{"id":100031,"date":"2018-03-20T07:22:45","date_gmt":"2018-03-20T12:22:45","guid":{"rendered":"https:\/\/www.thevwindependent.com\/news\/?p=100031"},"modified":"2018-03-20T07:40:42","modified_gmt":"2018-03-20T12:40:42","slug":"latta-introduces-bipartisan-otc-drug-bill","status":"publish","type":"post","link":"https:\/\/thevwindependent.com\/news\/2018\/03\/20\/latta-introduces-bipartisan-otc-drug-bill\/","title":{"rendered":"Latta introduces bipartisan OTC drug bill"},"content":{"rendered":"

VW independent\/submitted information<\/em><\/p>\n

WASHINGTON, D.C. —\u00a0U.S. Representative Bob Latta (R-Ohio) has introduced bipartisan legislation with members of the Energy and Commerce\u00a0Committee\u00a0to reform the outdated over-the-counter (OTC) monograph system.<\/p>\n

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Bob Latta<\/strong><\/figcaption><\/figure>\n

The legislation, the\u00a0Over-the-Counter Monograph Safety, Innovation, and Reform\u00a0Act<\/a>, modernizes the monograph framework and allows new, safe products to come to market more quickly while addressing safety issues and expanding consumer choice. This would\u00a0allow the Food and Drug Administration (FDA) to make scientific determinations for OTC ingredients through an\u00a0administrative\u00a0order process, which is much more efficient than the current rulemaking system.<\/p>\n

Introducing the legislation with Rep. Latta are\u00a0Rep. Michael Burgess, M.D. (R-Texas), Rep. Gene Green (D-Texas), Rep. Diana DeGette (D-Colorado), Rep. Brett Guthrie (R-Kentucky), and Rep. Debbie Dingell (D-Michigan).<\/p>\n

\u201cNearly every American uses over-the-counter products in some way,\u201d said Latta.\u00a0\u201cWhether it\u2019s treating allergies, helping with a cough, or seeking relief for\u00a0a headache, consumers want medicine that is safe, reliable, and affordable.<\/p>\n

\u201cIt\u2019s time to create a pathway for industry to enhance over-the-counter medicines and develop new, innovative products that will be a welcome addition to the current products so many American\u2019s depend on today,\u201d he added.\u00a0\u201cBy modernizing the decades-old monograph system and improving the way OTC drugs are approved, this bill will provide more certainty for\u00a0manufacturers, ensure consumer confidence, and foster innovation. The legislation introduced today was the result of bipartisan collaboration and discussion, and it\u2019s a big win for the countless consumers that purchase over-the-counter products.\u201d<\/p>\n

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.<\/p>\n

The draft legislation updates the monograph process by specifically adding a new section to the Food, Drug, and Cosmetic Act to:<\/p>\n