Proposed OTC monograph reform may spur innovation
The House Energy and Commerce Health Subcommittee on Wednesday approved bipartisan draft legislation to reform and modernize the OTC Monograph system.
More than 60% of pharmaceuticals on the U.S. market today are OTC medicines which provide Americans with safe, effective, and affordable therapies to treat and prevent many common ailments and conditions. Yet, the current OTC regulatory framework is based on a 45-year-old model that requires notice and comment rulemaking, an increasingly slow administrative process that has led to delays in completing OTC monographs and difficulties in updating product labels with new safety information.
Additionally, the current system does not provide a mechanism for innovation for new and/or improved products under the regulatory structure, the Consumer Healthcare Products Association reported.
“Today’s subcommittee vote marks a major step forward for OTC Monograph reform,” Scott Melville, president and CEO CHPa, said. “CHPA applauds the subcommittee ... for their leadership in advancing draft legislation that reflects more than two years of collaboration and compromise between regulators, lawmakers, public health stakeholders and industry.”The draft bill, authored by Reps. Bob Latta, R-Ore., Diana DeGette, D-Colo., subcommittee chairman Michael Burgess, R-Texas, vice chairman Brett Guthrie, R-Ky., ranking member Gene Green, D-Texas, and Rep. Debbie Dingell, D-Mich., was reported out of the subcommittee by voice vote.
“While CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use, it has become gridlocked and needs to be modernized,” said Melville, who testified before the subcommittee in September in strong support of OTC Monograph reform. “This legislation would not only help increase the efficiency and responsiveness necessary to protect consumer health, it would also spur innovation to provide consumers with additional self-care choices.”
More than 60% of pharmaceuticals on the U.S. market today are OTC medicines which provide Americans with safe, effective, and affordable therapies to treat and prevent many common ailments and conditions. Yet, the current OTC regulatory framework is based on a 45-year-old model that requires notice and comment rulemaking, an increasingly slow administrative process that has led to delays in completing OTC monographs and difficulties in updating product labels with new safety information.
Additionally, the current system does not provide a mechanism for innovation for new and/or improved products under the regulatory structure, the Consumer Healthcare Products Association reported.
“Today’s subcommittee vote marks a major step forward for OTC Monograph reform,” Scott Melville, president and CEO CHPa, said. “CHPA applauds the subcommittee ... for their leadership in advancing draft legislation that reflects more than two years of collaboration and compromise between regulators, lawmakers, public health stakeholders and industry.”The draft bill, authored by Reps. Bob Latta, R-Ore., Diana DeGette, D-Colo., subcommittee chairman Michael Burgess, R-Texas, vice chairman Brett Guthrie, R-Ky., ranking member Gene Green, D-Texas, and Rep. Debbie Dingell, D-Mich., was reported out of the subcommittee by voice vote.
“While CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use, it has become gridlocked and needs to be modernized,” said Melville, who testified before the subcommittee in September in strong support of OTC Monograph reform. “This legislation would not only help increase the efficiency and responsiveness necessary to protect consumer health, it would also spur innovation to provide consumers with additional self-care choices.”