[1] Direct-to-consumer advertising is only completely legal in New Zealand and the United States, but are subject to regulations regarding the balanced disclosure of a prescription's benefits in comparison to its risks (including but not limited to side effects and contraindications), among other factors.
There are ethical and regulatory concerns regarding DTCA, specifically the extent to which these ads may unduly influence the prescribing of the prescriptions based on consumer demands when, in some cases, they may not be medically necessary, or there are cheaper options available.
Critics of DTCA have argued that too much is spent on marketing medications, rather than into research and development; in the United States, ad spending by drugmakers reached US$5.2 billion in 2016.
A patient's request for a specific medication dramatically increases the rate at which physicians prescribe usually more expensive, branded drugs even when treatment for existing indications does not warrant such use.
[18] Pharmaceutical companies have also faced allegations of "disease mongering"—the process of promoting awareness of minor conditions such as balding and skin wrinkles in such a way that it encourages the sale of treatments for them.
[21] Advertisements generally begin within a year of drugs entering the market, before postmarketing surveillance is available to see if adverse effects emerge, which increases the risk of harm.
[23] Several DTC ads have faced criticism or FDA warnings over containing depictions of activities that are part of a prescription's contraindications, such as an advertisement for the blood thinner Xarelto which featured scenes of a patient spokesperson among motorcycles (despite a disclaimer stating that the spokes-patient had to stop riding her motorcycle while taking the medication), and a print ad for the Factor IX treatment Idelvion containing an image of a soccer player (with the FDA warning that soccer was a "moderate to dangerous high-risk activity for hemophilic patients", and that the ad falsely implied patients could engage in such activity without consequences).
"[30] U.S. DTC regulations have led to drug commercials having formulaic elements that have often been parodied in popular culture, such as the juxtaposition of often-lighthearted footage with the mandated reading of side effects.
[31] The long-running variety show Saturday Night Live has featured sketches with parody commercials for drugs, many of which featuring exaggerated side effects (such as "Annuelle"—a parody of Seasonale that lets women have their period only once per-year, at the cost of having extreme PMS symptoms when it does occur, and "Ozempic for Ramadan", whose side effects include "going straight to hell") or inane purposes (such as "Swiftamine", a medication for people who experience onset vertigo after realizing they love Taylor Swift).
[10] In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited.
[10][37] Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad.
[9][38] In October 2002, the European Commission voted against a proposal to selectively allow advertising of "disease education information" in relation to AIDS, asthma, and diabetes.
Despite insistence otherwise due to its selective and controlled nature, the European Parliament Committee on the Environment, Public Health and Food Safety assessed that the pharmaceutical industry could not be trusted to provide impartial and unbiased information.
[44] In a 2005 Health Select Committee hearing, GlaxoSmithKline UK general manager Eddie Gray stated that the company did not plan to lobby for DTC in the region, citing prevailing consumer attitudes against the concept.
[45][46] Under the regulations of the Food and Drug Administration (FDA), direct-to-consumer "product claim" advertisements for a prescription medication must include information on their major side effects and contraindications in the main body, with a "fair balance" in its coverage of benefits to risks.
[47][6] Print ads must contain a standard notice that instructs patients to report negative side effects and adverse events to the FDA's MedWatch program.
FDA commissioner Arthur Hayes showed reservations for the impact that DTCA would have on the industry and public health, and called for a moratorium in September 1983 pending further regulations.
[54] On March 4, 2016, Senator Al Franken introduced the Protecting Americans from Drug Marketing Act, which proposed the removal of tax breaks for pharmaceutical companies who engage in DTCA.
[55][53] On May 8, 2019, the Department of Health and Human Services (HHS) approved a mandate for list prices to be displayed in advertising for any prescription that costs $35 or higher for 30 days of treatment.
Secretary of Health and Human Services Alex Azar compared the proposed requirement to similar regulations involving list prices for automobiles.