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The fair balance requirement states that a drug advertisement must present a fair assessment of the drug’s risks balanced with the presentation of its benefits.
The FDA recently sent a letter to ACME instructing it to change its ads for WellRun so that they included a fair balance of the risk of heart problems.
The requirement is generally discussed in relation to direct-to-consumer (DTC) advertising, though it also applies to ads targeting health care professionals. This requirement does not mean that ads must give equal space or time to risks, but rather that their presentation must be in proportion to their likelihood and potential seriousness as well as the presentation of the benefits. If an ad does not make very strong claims about the safety and effectiveness of the drug, the presentation of the risks also need not be very strong. The risks presented are those found in the drug’s approved labeling.
Podmínka spravedlivé rovnováhy požaduje, aby reklama na léky prezentovala spravedlivé posouzení rizik léku přiměřené prezentaci jeho přínosů.
FDA nedávno zaslala dopis společnosti ACME, který jí ukládal změnit reklamy na lék WellRun tak, aby obsahovaly spravedlivou rovnováhu rizika srdečních problémů.
Tento požadavek je obvykle probírán v souvislosti s reklamou zaměřenou na spotřebitele, ačkoli se také vztahuje na reklamy, které cílí na zdravotnické odborníky. Tento požadavek neznamená, že reklamy musí věnovat stejný prostor nebo čas rizikům, ale že jejich prezentace musí být přiměřená jejich pravděpodobnosti a potenciální vážnosti stejně jako prezentace přínosů. Pokud reklama neuvádí příliš silná tvrzení ohledně bezpečnosti a účinnosti léku, prezentace rizik také nemusí být příliš silná. Prezentovaná rizika jsou ta, která se nacházejí na schváleném označení léku.
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English Editorial Services’ mission is to assist international businesses and organizations of all sizes to communicate clearly, correctly, and persuasively with their business partners and target audiences.
Simply subscribe to receive our Business Term of the Day at no charge to your inbox each business day, with explanation in English and Czech.
