Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of H.R. 5333, the Over-the- Counter Monograph, Safety, Innovation and Reform Act. I am a proud original cosponsor of this legislation that will…
Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 5333, the Over-the- Counter Monograph, Safety, Innovation and Reform Act.
I am a proud original cosponsor of this legislation that will strengthen the Food and Drug Administration's ability to oversee the over-the-counter drug market and establish a user fee program for this market for the first time.
H.R. 5333 is legislation that enjoys bipartisan support and would reform the current monograph system that is relied upon by industry to legally market over-the-counter drugs in response to concerns raised by both the FDA and the industry that the current system is outdated and burdensome.
Under current law, the safety and effectiveness of over-the-counter drugs is established through conformance with a monograph. Monographs serve as a type of rule book outlining the conditions of use for a particular drug ingredient, including the dosage form, patient population, labeling and warnings, and other requirements. This rule book is established currently through a three-phase rulemaking process and is very resource and time intensive.
This process has made it difficult for the FDA to finalize, revise, or update monographs to reflect innovations, changes in science, or to respond to safety issues.
We also have heard from the industry that the current process inadvertently discourages innovation, as it is not nimble enough to respond to evolving science and technology.
The legislation we are considering today would address these concerns by transitioning the monograph system from rulemaking to administrative order, create a procedure for the FDA to respond to the needs for safety label changes, and establish an innovation pathway.
These reforms can only be successful if it is also accompanied by stable and reliable funding that more appropriately represents the growth and science of the over-the-counter industry.
Today, the over-the-counter monograph program oversees more than 100,000 products with a staff of about 30 people and a budget of just over $8 million. The user fees provided in this bill would help the FDA transition the monograph program from rulemaking to administrative order, provide for additional staff capacity, and enable the FDA to respond to innovation and safety changes in the current market.
I want to thank my colleague from Ohio, Congressman Bob Latta, for introducing this legislation and for working with me and other members of our committee. I would like to thank the original cosponsors of the bill, Representative Diana DeGette, Representative Debbie Dingell, Chairman Mike Burgess, and Representative Brett Guthrie for their dedication and hard work on this important issue.
I ask all my colleagues to join me in supporting the Over-the-Counter Monograph Safety, Innovation, and Reform Act.
Mr. Speaker, I reserve the balance of my time.
Mr. Speaker, I yield 3 minutes to the gentlewoman from Michigan (Mrs. Dingell).
Mr. Speaker, I yield 3 minutes to the gentlewoman from Colorado (Ms. DeGette), my colleague and a member of our committee.
Mr. Speaker, I have no other speakers, and I yield back the balance of my time.