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senate Bill S. 2740

Should the Process for Over-the-Counter Drug Approvals Be Modernized?

Argument in favor

This bipartisan bill would modernize the FDA’s broken process for approving over-the-counter medical products to better serve the American public and allow for innovative products to reach the people who need them.

NoHedges's Opinion
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12/11/2019
Modernization is necessary AND this is why pharmaceutical companies must pay equitable taxes. That way the industry can become self sustaining WITHOUT TAX PAYERS DOLLARS. But, not until Trump is removed will I vote to authorize any further spending. It is obvious taxpayers dollars that have been designated DO NOT REACH THE INTENDED Recipient. So, until I see a balance sheet showing what is still outstanding, WHY ON EARTH WOULD I vote to authorize any further spending? Ukraine hasn’t even received all of their military aide!
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RjGoodman's Opinion
···
12/11/2019
The FDA OTC approval process is inefficient and has too much influence by the Pharma companies who have branded rights. This bill would modernize the FDA’s process for approving over-the-counter medical products to better serve the American public and allow for innovative products to reach the people who need them in a timely manner.
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Jeanne's Opinion
···
12/11/2019
There are numerous medications that could be made OTC including the birth control pill. Antimicrobials must never be OTC. This is asking for more virulent antimicrobial resistant organisms. Regular people don’t know the difference between the cold, the flu and and infection caused by microorganisms that are cured by antimicrobials. OTC antimicrobials would be a disaster.
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Argument opposed

This bill would make too many changes to the processes involved with bringing over-the-counter drugs to market, and doesn’t provide an adequate way to pay for the FDA’s oversight.

jimK's Opinion
···
12/11/2019
Huh! What exactly is being changed that modernizes the OTC drug approval process? I am all for better oversight by the FDA of OTC drugs but cannot tell how this would improve that oversight. It sounds like the process would cause OTC drug prices to increase in order to comply with FDA monitoring of use and distribution of OTC drugs- but I don’t see plans to increase staff to actually do that monitoring or how that monitoring would translate into action. The only thing I can see for sure is that this legislation will increase the costs of purchasing OTC drugs, and make prescribed drugs more attractively priced. Forgive my ignorance on how this actually works; I will have to review postings to see if anyone can explain this. For now at least, I say NAY- since I can kind of see the ‘cost’ but cannot pin down the ‘benefit’.
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David 's Opinion
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12/11/2019
There is insufficient information here. On the face it looks like the bill essentially lets the industry regulate itself - NOT a good idea. Historically self-regulation has resulted in massive abuse by the industry participants. How would this bill make that different? It’s not clear.
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Brian's Opinion
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12/11/2019
I think modernization is good, and I do think we should have more access to innovative drugs, but this bill needs to be fully paid for and keep consumer safety at the front. I'm afraid of this current "repeal all regulations" approach the right seems to want (except for, you know, guns, gays, and abortion). We need to be sure people are still protected from unproven drugs.
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bill Progress


  • Not enacted
    The President has not signed this bill
  • The house has not voted
      house Committees
      Committee on Energy and Commerce
  • The senate has not voted
      senate Committees
      Committee on Health, Education, Labor, and Pensions
    IntroducedOctober 30th, 2019

What is Senate Bill S. 2740?

This bill — the OTC Monograph Safety, Innovation, and Reform Act  — would change the monograph rulemaking process to an administrative order process (which is the same legal authority used for other medical product approvals. It would allow the Dept. of Health & Human Services (HHS) to take rapid action to protect public health if safety issues emerge.

The bill would also establish processes for manufacturers to request administrative orders, or for the secretary to initiate administrative orders at the recommendation of the FDA or in response to citizens’ petitions; and for drug developers to request meetings with the FDA, similar to existing processes for prescription drug development.

A new incentive would be created to bring innovative over-the-counter products to consumers by providing an 18-month period of product differentiation to reward innovation.

The Food & Drug Administration (FDA) would be required to provide an annual update to Congress on its evaluation of the cold & cough monograph with respect to children under the age of 6. The FDA would be authorized to collect user fees so that it has the necessary resources to evaluate & monitor the over-the-counter market.

Impact

Over-the-counter drugs and those who consume them; pharmaceutical companies; and the FDA.

Cost of Senate Bill S. 2740

A CBO cost estimate is unavailable.

More Information

In-DepthSen. Johnny Isakson (R-GA) introduced this bill to streamline and modernize the FDA’s process for approving over-the-counter drugs:

“It is past time to modernize and overhaul our woefully outdated over-the-counter drug approval process. I’m reintroducing the Over-the-Counter Monograph Safety, Innovation, and Reform Act to help ensure that the health products in Americans’ medicine cabinets and on supermarket shelves are effective and accessible for patients, that innovations can be made well into the future, and that we promote competition to bring down costs for consumers.”

Lead Democratic cosponsor Sen. Bob Casey (D-PA) added:

“The over-the-counter monograph system is outdated and has not kept pace with the needs of the American public or the changing drug market for decades. The Over-the-Counter Monograph Safety, Innovation, and Reform Act would make commonsense updates to modernize the regulation of over-the-counter drugs to provide confidence to American consumers that non-prescription drugs have appropriate oversight from the FDA, and that the FDA has the authority to take swift action to protect public health should a safety problem occur. This legislation has been the product of years of work, and I urge the Senate to take swift action to pass it.”

This legislation has the support of four bipartisan cosponsors evenly divided between Republicans & Democrats, and passed the Senate HELP Committee without an amendment. In the last Congress, the committee approved this bill’s predecessor on a 22-1 vote.


Media:

Summary by Eric Revell

(Photo Credit: iStock.com / gradyreese)

AKA

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

Official Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes.

    Modernization is necessary AND this is why pharmaceutical companies must pay equitable taxes. That way the industry can become self sustaining WITHOUT TAX PAYERS DOLLARS. But, not until Trump is removed will I vote to authorize any further spending. It is obvious taxpayers dollars that have been designated DO NOT REACH THE INTENDED Recipient. So, until I see a balance sheet showing what is still outstanding, WHY ON EARTH WOULD I vote to authorize any further spending? Ukraine hasn’t even received all of their military aide!
    Like (14)
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    Share
    Huh! What exactly is being changed that modernizes the OTC drug approval process? I am all for better oversight by the FDA of OTC drugs but cannot tell how this would improve that oversight. It sounds like the process would cause OTC drug prices to increase in order to comply with FDA monitoring of use and distribution of OTC drugs- but I don’t see plans to increase staff to actually do that monitoring or how that monitoring would translate into action. The only thing I can see for sure is that this legislation will increase the costs of purchasing OTC drugs, and make prescribed drugs more attractively priced. Forgive my ignorance on how this actually works; I will have to review postings to see if anyone can explain this. For now at least, I say NAY- since I can kind of see the ‘cost’ but cannot pin down the ‘benefit’.
    Like (20)
    Follow
    Share
    There is insufficient information here. On the face it looks like the bill essentially lets the industry regulate itself - NOT a good idea. Historically self-regulation has resulted in massive abuse by the industry participants. How would this bill make that different? It’s not clear.
    Like (15)
    Follow
    Share
    I think modernization is good, and I do think we should have more access to innovative drugs, but this bill needs to be fully paid for and keep consumer safety at the front. I'm afraid of this current "repeal all regulations" approach the right seems to want (except for, you know, guns, gays, and abortion). We need to be sure people are still protected from unproven drugs.
    Like (11)
    Follow
    Share
    Trust? How are these new drugs to be tested. I believe the process now is largely in the hands of the pharmaceutical companies. If the issue is moving medications brands to over the counter where are these medications coming from, a pharmaceutical company? I believe that the devil is in the details here and we aren’t being given the details.
    Like (10)
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    The FDA OTC approval process is inefficient and has too much influence by the Pharma companies who have branded rights. This bill would modernize the FDA’s process for approving over-the-counter medical products to better serve the American public and allow for innovative products to reach the people who need them in a timely manner.
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    The fact that the gop doesn’t understand the difference between a cloud server and a physical server, means I oppose the gop writing legislation to modernize anything.
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    The information given says that it will modernize and make it easier for medications to become over-the-counter. However, it does not say how the process will be modernized. What steps will be cut out? And, are they steps that could potentially be harmful to consumers? Also, which types of medications would become available and will the costs of those medications come down (as now they will not be covered by insurance). Is this just the way of prepare for Universal Coverage? Make most drugs OTC to keep prices high??? I want more information.
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    Insufficient information to understand how this legislation helps the current process and is not just muddying the waters. Currently, “FDA publishes monographs that provide a rulebook for marketing safe and effective products containing particular active ingredients for specific OTC conditions. Products that conform to the monograph rules and other relevant requirements are not required to be reviewed by FDA before marketing.” “the OTC marketplace must have more resources if FDA is to fully realize the goals of reform and ensure the safety and effectiveness of OTC drugs, as well as support innovation by industry. “ So, what exactly is the improvement provided in this legislation? It seems FDA just needs more resources to process changes but this legislation is not proposing that. https://www.fda.gov/news-events/congressional-testimony/modernizing-fdas-regulation-over-counter-drugs
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    There are numerous medications that could be made OTC including the birth control pill. Antimicrobials must never be OTC. This is asking for more virulent antimicrobial resistant organisms. Regular people don’t know the difference between the cold, the flu and and infection caused by microorganisms that are cured by antimicrobials. OTC antimicrobials would be a disaster.
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    Move carefully on this bill please and just don’t pass it.
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    The American people are quite capable of making many medical decisions without the input of medical professionals. It sounds like this bill could bring down medical costs
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    Every day we hear of someone harmed by an approved drug’s side affects. Is this another program to be handed over to private organizations! Lunacy!
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    This bill reeks of pay to get your product over the finish line whether it is ready or not. This administration is all too willing to take "incentives" to giving one company a head start over another.
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    No, this bill is authored by a Republican; they never have the interests of the people in their empty minds! Why don’t the Republicans do something positive for the kids being tortured in cages at our Southern borders???
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    I don’t like this legislation. I have a prescription plan that covers my pharmaceuticals and now I will be paying out of pocket BUT on the other hand people without prescription plans will be better able to afford pharmaceuticals. This is always the dilemma. We need to fix our healthcare and prescription plans.
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    LEAVE US THE HELL ALONE RINO's & DEMONCRATS!
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    Break down the barriers to get more safe drugs for an over the counter price in American hands.
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    Not enough information.
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    The FDA is the good standard of public health for the world. Smattering buzz words like “modernize” and “streamline” in a bill that didn’t get enacted the first time it was introduced doesn’t have any merit in my opinion. Keep the current system in place.
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