Congress seeks to update OTC monograph system
Rep. Bob Latta, R-Ohio, on Monday introduced bipartisan legislation along with members of the Energy and Commerce Committee to reform the outdated over-the-counter monograph system. The legislation, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, modernizes the monograph framework and allows new, safe products to come to market more quickly while addressing safety issues and expanding consumer choice.
“While the OTC Monograph system is a smart, balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use and efficacy, it relies on notice and comment rulemaking which has become an increasingly slow and unresponsive administrative process,” Scott Melville, president and CEO for the Consumer Healthfare Products Association, said. “As a result, the Monograph system has become cumbersome and, essentially, has ground to a halt. Today, it can take several years or more to update product labels with new safety information, approve new ingredients or make other important changes for consumers. Moreover, the current system does not provide a mechanism for innovation.”
“Nearly every American uses over-the-counter products in some way,” Latta said. “It’s 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 Americans depend on today. By modernizing the decades-old monograph system and improving the way OTC drugs are approved, this bill will provide more certainty for manufacturers, ensure consumer confidence and foster innovation.”
The new bill would allow the Food and Drug Administration to make scientific determinations for OTC ingredients through an administrative order process, which is much more efficient than the current rulemaking system. The current system has not had a significant update since 1972.
“With more than 300,000 over-the-counter products on the market, that is far too long to wait,” Rep. Michael Burgess, R-Texas, said. “The bill introduced today will ensure that American development remains at the helm of over-the-counter drug innovation. I am grateful to Congressman Latta for his leadership on this issue, and I look forward to bringing our over-the-counter monograph system into the 21st century.”
Introducing the legislation with Latta and Burgess are Reps. Gene Green, D-Texas, Diana DeGette, D-Colo., Brett Guthrie, R-Ky., and Debbie Dingell, D-Mich.
“Over-the-counter drugs provide an affordable way for Americans to seek medical treatment,” Guthrie said. “Unfortunately, the current FDA approval process for over-the-counter products is too slow, delaying important innovations that can help patients more quickly.”
The OTC monograph system was established in 1972 by 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 benefiting consumers, where none currently exits;
- Ensure the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected; and
- Include by reference existing OTC Review Final Monographs and deem final Tentative Final Monographs by statute.
FTC sends refunds to buyers of bogus diet aids
As an example of how government agencies are cracking down on outliers purporting to be in the dietary supplement business, the Federal Trade Commission last week mailed 18,301 refund checks totaling more than $437,000 to people who bought bogus diet aids from Colby Fox, Christopher Reinhold and their companies, Tachht and Teqqi. According to the FTC, the defendants bombarded people with illegal spam email and used false celebrity endorsements and false weight-loss claims to pitch their products.
The average check amount was $23.91.
In June 2016, the FTC charged the defendants with paying to send emails from hacked accounts to consumers, making it appear that the messages came from their family members, friends or other contacts. The messages promoted the defendants’ unproven weight-loss products Original Pure Forskolin and Original White Kidney Bean.
Two court orders settling the FTC’s charges, entered in March and September 2017, barred the defendants from the allegedly illegal conduct and required the defendants to pay $500,000 for refunds to defrauded consumers.
FTC law enforcement actions led to more than $6.4 billion in refunds for consumers in a one-year period between July 2016 and June 2017.
Most severe flu season may go in the books as longest on record, too
Not only has this year’s flu season broken records as to how many people have been impacted by the flu, it may soon break records as to how long the season has lasted. For the week ended March 10, the Centers for Disease Control and Prevention on Friday reported influenza-like activity of 3.3%. It’s the 16th week ILI has been reported above the national baseline of 2.2%.
And flu activity is likely to remain elevated for several more weeks, the CDC reported.
Only two seasons in the past 10 years have lasted longer – ILI activity for both the 2016/2017 flu season and the 2012/2013 flu season tracked above the 2.2% baseline for a total of 17 weeks.
According to the CDC, current data indicate that the 2017-2018 flu season peaked at 7.5% in early February and is now on the decline. However, 26 states plus Puerto Rico continue to report widespread flu activity and 12 states continue to experience high ILI activity.
The overall hospitalization rate and all age-specific hospitalization rates are higher than the end-of-season hospitalization rates for 2014-2015, a high severity, H3N2-predominant season. CDC also is reporting an additional 9 flu-related pediatric deaths during week 10, bringing the total number of flu-related pediatric deaths reported this season to 128.
While H3N2 viruses remained predominant overall this season, the proportion of influenza B vs. influenza A viruses is now about even. Early vaccine effectiveness estimates through Feb. 3, 2018 show that flu vaccine has reduced the risk of having to go to the doctor due to flu by 36% overall. VE against H3N2 viruses was 25%. VE against H1N1 67% and VE against B viruses was 42%. CDC recommends prompt treatment with influenza antiviral medications for people who are severely ill and people who are at high risk of serious flu complications who develop flu symptoms.
Since Oct. 1, 2017, 25,676 laboratory-confirmed influenza-associated hospitalizations have been reported through the Influenza Hospitalization Network, a population-based surveillance network for laboratory-confirmed influenza-associated hospitalizations. This translates to a cumulative overall rate of 89.9 hospitalizations per 100,000 people in the United States.