Submitted by Admin on Thu, 08/20/2015 - 14:11

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The draft guidance gives companies additional discretion about which risks to disclose and how.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.

Moreover, the new guidance is not particularly clear or coherent. For example, it states that the “FDA does not intend to object if a firm does not include `each specific side effect and contraindication,'” but a few pages later, it says that “information addressing the following should be included: . . . All Contraindications.”1 Admittedly, this is only a draft document, and clearer guidance may be provided in the final version. Unfortunately, the FDA often allows draft documents to linger for years — the previous draft guidelines on print advertisements were still not finalized even after a decade. Even final guidance documents are technically not binding, but even in draft form they tend to be very influential in an industry that must work with the FDA on a daily basis. When the guidance remains in draft form perpetually, however, it exacerbates the regulatory ambiguity.