Citizens Soap Box

Category

City Images wishes to know what's on your mind... Speak up, citizens!

This originates from the days when individuals would stand on a wooden crate used for shipment of soap or any other dry goods from a manufacturer to a distributor.

So, we want to know what's bugging you? Write to your heart's content.

What's keeping you up at night and worth sharing with the online community?

The truth is many of our leaders don’t know enough about what we want and need. Your stories help them better understand the value of the taxes you and your families pay to support your area.

We’ve already sent multiple messages to our elected leaders. And each time you send legislators your thoughts, they get the message: we want fair and clear rules for all our citizens.

Now, it’s your turn to make your voice be HEARD!!!

EMPOWER CONSUMERS

Solution

According to the New England Journal of Medicine... As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a printed magazine ad. Companies have tended to comply with this requirement by supplementing colorful, persuasive ads with one or two pages of dry text providing the required disclosures, often simply using language that the FDA has approved for other purposes, such as package inserts for prescribers. But research shows that most patients who attempt to read these disclosures find them difficult to understand, and many don't even try to make sense of them.1 Now, the FDA is in the process of adjusting its DTCA rules, aiming to provide greater assurance that patients receive due warning of the most significant risks — but its tweaks probably don't go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies.

This spring, the FDA revised its guidance for communicating risks in DTCA, which had been in “draft” form since 2004.1 The agency has long recommended the use of nontechnical language (e.g., “drowsiness” rather than “somnolence”) but now also recommends using an evidence-based format for conveying such information. The FDA's research supports the use of a “Drug Facts” box, of the type that has proven successful for over-the-counter products, with familiar headings for “Uses” and “Warnings.” Alternatively, companies will be allowed to use a question-and-answer format, as some have already been doing.

The draft guidance gives companies additional discretion about which risks to disclose and how. Though the FDA continues to insist that any “black-box” warnings and contraindications be included, companies will now be able to omit mention of other adverse events. The guidance directs companies to include only the “most serious and the most common” risks posed by a product. The idea that it actually helps to give consumers less of the available information about a product's risks may be counterintuitive, but the FDA is reasonably concerned that the recital of extremely rare risks can distract from, or even trivialize, the more significant disadvantages of a product.

Still, the guidance raises difficult questions about which risks to exclude, and it's worrisome when discretion is given to marketers who have an interest in downplaying overall risks. For the industry, such discretion is a double-edged sword. If a patient experiences an adverse effect and files a lawsuit, a civil jury may find that the advertising was misleading, and a company's defense may receive little support from the FDA's vague guidance. Some conservative companies may therefore prefer to continue providing comprehensive lists, and the new guidance allows them to do so. If the FDA is serious about streamlining disclosures, it may need to take a stronger approach.

Comments

Query

Is the poem the only one in the Citizens' Soap Box? Where are the rest, if any?

DEAR LADY

Dear Lady standing by the sea
You are a welcome sight to see
I have left the walls and shores of tyranny
And now I gaze at thee
You stand so tall for all to see
Your burning torch lights up the night
So all can see your Crown of Liberty
We who have come from across the sea
Stand on crowded decks to gaze at thee
I know that if by chance you gaze at me
My only wish is to be free
Dear Lady standing by the sea.

By City Islander Jim Mullarkey
82nd Airborne Division