HB 24-15: Drug Advertisements Regulation Act (Passed)

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A BILL
To stop the proliferation of dangerous prescription drug ads

Be it resolved by the Senate and the House of Representatives, in Congress assembled:

Section 1: Name
1. This bill may be cited as the "Drug Advertisements Regulation Act"

Section 2: The ads themselves

1. Advertisements that do comply with the requirements established in Section 2.1 must follow the following guidelines about their messages:

a) The advertising nature of the message must be clear and it must be clearly specified that the product in question is a drug
b) The scientific denomination(s) of the drug in question shall be included in the advertisement
c) All information necessary for the correct usage of the drug, as well as an invitation to read the drug's instructions shall be provided in the advertisement
d) Advertisements must not include expressions that provide certainty of healing or testimony about the product's virtues from professionals or people whose notoriety could induce to consumption. Any actors that appear in the advertisements must be either licensed sanitary professionals or people who have consumed the drug by themselves under medical suggestions.=
e) Advertisements must not use as an argument the fact that they have obtained a sanitary authorization in a foreign country, nor any other sort of sanitary authorization or certification that is mandatory by law
f) Advertisements in audiovisual media must comply with the guidelines for accessibility for disabled people covered in the relevant guidelines for government publicity

2. Contests, raffles, bonifications and similar methods are banned to be used as linked to the advertisement of drugs

Section 3. Enactment
1. This bill shall be enacted immediately after passage

People's Regional Senate
Passed 3-0-1 in the Atlasian Senate Assembled,

Sponsor: Thumb21
House Designation: HR 24-15

72 hours to debate.

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This bill puts in place some regulations to stop misleading advertising from companies advertising any drug. Any drug will have varying positive and negative side effects and I think its reasonable that advertising should not paint a completely rosy picture, that might be in the interests of a pharmaceutical company trying to sell their product but not in the interests of people who should be allowed to make an informed decision.

I notice a little issue where there is a reference to a part of the bill which has since been removed. I plan to fix this.

[cinyc]

What is a “licensed sanitary professional?” I’ve never heard that term before.

[Fmr. Representative Encke]

Yeah, I'm confused about that term as well. There is a grand total of one search result for that specific term in Google, and it's a sewage treatment report from Haiti.

Tack wrote the bill and modeled it after Spanish legislation so perhaps there's something being lost in translation here.

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An amendment to deal with the reference to a part of the bill than no longer exists and fixes the part about licensed sanitary professionals.

A BILL
To stop the proliferation of dangerous prescription drug ads

Be it resolved by the Senate and the House of Representatives, in Congress assembled:

Section 1: Name
1. This bill may be cited as the "Drug Advertisements Regulation Act"

Section 2: The ads themselves Regulations

1. Advertisements that do comply with the requirements established in Section 2.1 of drugs for human consumption in media intended for the general public must follow the following guidelines about their messages:

a) The advertising nature of the message must be clear and it must be clearly specified that the product in question is a drug
b) The scientific denomination(s) of the drug in question shall be included in the advertisement
c) All information necessary for the correct usage of the drug, as well as an invitation to read the drug's instructions shall be provided in the advertisement
d) Advertisements must not include expressions that provide certainty of healing or testimony about the product's virtues from professionals or people whose notoriety could induce to consumption. Any actors that appear in the advertisements must be either licensed sanitary health care professionals or people who have consumed the drug by themselves under medical suggestions.
e) Advertisements must not use as an argument the fact that they have obtained a sanitary authorization in a foreign country, nor any other sort of sanitary authorization or certification that is mandatory by law
f) Advertisements in audiovisual media must comply with the guidelines for accessibility for disabled people covered in the relevant guidelines for government publicity

2. Contests, raffles, bonifications and similar methods are banned to be used as linked to the advertisement of drugs

Section 3. Enactment
1. This bill shall be enacted immediately after passage

People's Regional Senate
Passed 3-0-1 in the Atlasian Senate Assembled,

[Fmr. Representative Encke]

The amendment looks fine.

But don't we already have legislation like this in the US? Every time I see a drug advertisement on TV, I see these sorts of disclaimers (e.g. stating that the product is a drug). Just want to make sure that we aren't unnecessarily rewording or overwriting existing legislation that may actually be more comprehensive than the material covered in this bill.

[Fmr. Representative Encke]

Some other things:

What are the penalties for not complying with the legislation?

How is it determined whether actors have "consumed the drug by themselves under medical suggestions?"

What is meant by "scientific denomination(s) of the drug?" Is this referring to the chemical composition? Or is it referring to the generic/non-proprietary name? As an example, (RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid is an example of the chemical name, and 'ibuprofen' is the general name (note that this is not the same as the brand name). If the bill's intention is for the chemical composition to appear in the commercial, I highly doubt that this would provide the average viewer with any useful information.

I also don't see the point of requiring advertisements to provide all information necessary for correct usage of the drug. Do we think people are watching commercials and writing down the usage instructions?

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After a little more research, I am not under the impression that current regulations are tough enough.

You can find simple a simple break down of the regulations for prescription only drug advertising here: https://www.fda.gov/drugs/drug-information-consumers/prescription-drug-advertising

This is also useful: https://www.express-scripts.com/art/pdf/kap55Medications.pdf

"The regulatory oversight of OTC medication promotion is the
responsibility of the FTC. The FTC standards for OTC drug promotion require
advertising to be truthful and non-deceptive, require the advertiser to have
evidence to back up their claims, and require that the ads cannot be unfair. The
evidence standard requires “competent and reliable scientific evidence.” The
FDA’s standard for “substantial evidence” is technically and legally much
stricter."

As for the point about correct usage information on drugs, I think the broader point is that the nature of any drug advert should have an informative nature rather than a commercial one. Very few people will be taking note of all the details of the drug but more people will be interested in what the drug does, what it is and how it should be taken. I still think as many details as possible for people who will read it.

I'm also not sure what was meant by scientific denomination of the drug, Tack might be able to explain that.

[Former President tack50]

Ok since I see I've been mentioned a couple times, here are some clarifications.

The "licensed sanitary professionals" part would have referred to people who are actually workers in the healthcare field and have the proper license to do so. So basically doctors, nurses, physicians, etc.

This is something I introduced from a suggestion from MB:

One of the problems with prescription drug ads is they usually hire paid actors instead of actual patients who took the drug. I'd also probably want to address this in section 3.

I suppose I probably indeed mistranslated "Profesionales sanitarios" as "Sanitary professionals" instead of "Healthcare professionals" like Thumb's ammendment did.

As for the scientific denomination of the drug, by this I mean that the "active principle" of the drug should be mentioned.

For exmple; in any advertisements of Tylenol, the common pain-killer drug; the word "Paracetamol" (or given this is Atlasia, "Acetaminophen") should appear somewhere in the advertisement.

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Amendment is adopted

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An amendment which rewords the scientific denomination term to something more defined and also sets the responsibility for enforcing of these regulations, which under existing regulations is the FDA for prescription and FTC for over the counter - so this just extends the current enforcement of drug advertising regulations to these regulations also.

A BILL
To stop the proliferation of dangerous prescription drug ads

Be it resolved by the Senate and the House of Representatives, in Congress assembled:

Section 1: Name
1. This bill may be cited as the "Drug Advertisements Regulation Act"

Section 2: Regulations

1. Advertisements of drugs for human consumption in media intended for the general public must follow the following guidelines about their messages:
a) The advertising nature of the message must be clear and it must be clearly specified that the product in question is a drug
b) The scientific denomination(s) active principle of the drug in question shall be included in the advertisement
c) All information necessary for the correct usage of the drug, as well as an invitation to read the drug's instructions shall be provided in the advertisement
d) Advertisements must not include expressions that provide certainty of healing or testimony about the product's virtues from professionals or people whose notoriety could induce to consumption. Any actors that appear in the advertisements must be either licensed health care professionals or people who have consumed the drug by themselves under medical suggestions.
e) Advertisements must not use as an argument the fact that they have obtained a sanitary authorization in a foreign country, nor any other sort of sanitary authorization or certification that is mandatory by law
f) Advertisements in audiovisual media must comply with the guidelines for accessibility for disabled people covered in the relevant guidelines for government publicity

2. Contests, raffles, bonifications and similar methods are banned to be used as linked to the advertisement of drugs

Section 3. Enforcement

1. The responsibility to oversee and enforce the regulations in Section 2 shall lie with the:
a) Food and Drug Administration (FDA) for the advertisement of prescription-only medication.
b) Federal Trade Commission (FTC) for the advertisement of all other drugs.

Section 4. Enactment
1. This bill shall be enacted immediately after passage

People's Regional Senate
Passed 3-0-1 in the Atlasian Senate Assembled,

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Amendment is adopted

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Does anyone have anything else to add to this or are we ready to vote?

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Motion for a final vote

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Final Vote

72 hours

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Aye

[P. Clodius Pulcher did nothing wrong]

Aye

[cinyc]

Nay

[Fmr. Representative Encke]

Nay.

Said this earlier, but these regulations are more restrictive than I think is necessary. These advertisements exist to inform people that a drug exists to treat X condition, not to inform people exactly how to take the drug (stuff that the average person wouldn't understand or care about when they first hear about the drug). The important things (listing important risks and side effects, for instance) are already covered in present regulations.

[PPT Spiral]

Aye

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Passed

3-2-0-4

[thumb21]

A BILL
To stop the proliferation of dangerous prescription drug ads

Be it resolved by the Senate and the House of Representatives, in Congress assembled:

Section 1: Name
1. This bill may be cited as the "Drug Advertisements Regulation Act"

Section 2: Regulations

1. Advertisements of drugs for human consumption in media intended for the general public must follow the following guidelines about their messages:
a) The advertising nature of the message must be clear and it must be clearly specified that the product in question is a drug
b) The active principle of the drug in question shall be included in the advertisement
c) All information necessary for the correct usage of the drug, as well as an invitation to read the drug's instructions shall be provided in the advertisement
d) Advertisements must not include expressions that provide certainty of healing or testimony about the product's virtues from professionals or people whose notoriety could induce to consumption. Any actors that appear in the advertisements must be either licensed health care professionals or people who have consumed the drug by themselves under medical suggestions.
e) Advertisements must not use as an argument the fact that they have obtained a sanitary authorization in a foreign country, nor any other sort of sanitary authorization or certification that is mandatory by law
f) Advertisements in audiovisual media must comply with the guidelines for accessibility for disabled people covered in the relevant guidelines for government publicity

2. Contests, raffles, bonifications and similar methods are banned to be used as linked to the advertisement of drugs

Section 3. Enforcement

1. The responsibility to oversee and enforce the regulations in Section 2 shall lie with the:
a) Food and Drug Administration (FDA) for the advertisement of prescription-only medication.
b) Federal Trade Commission (FTC) for the advertisement of all other drugs.

Section 4. Enactment
1. This bill shall be enacted immediately after passage

People's Regional Senate
Passed 3-0-1 in the Atlasian Senate Assembled,

House of Representatives
Passed the House of Representatives 3-2-0-4