NewStandard, April 20, 2007
Title: “FDA Complicit in Pushing Prescription Drugs, Ad Critics Say”
Author: Shreema Mehta
Student Researchers: Lauren Anderson, Corey Sharp-Sabatino, and Marie Daghlian
Faculty Evaluator: Noel Byrne, PhD
While the US Food and Drug Administration (FDA) turns a blind eye, drug companies are making false, unsubstantiated, and misleading claims in their advertising, often withholding mandated disclosure of dangerous side effects. Though companies are required to submit their advertisements to the FDA, the agency does not review them before they are released to the public. A Government Accountability Office report released November 2006 found that the FDA reviews only a small portion of the advertisements it receives, and does not review them using consistent criteria.
Claiming lack of funds and resources necessary to impose effective regulations on drug marketing, the FDA is asking Congress to charge drug companies fees in order to fund FDA review of advertisements before they go public as part of renewing the Prescription Drug User Fee Act (PDUFA). PDUFA has come under fire from consumer advocates who say it gives the pharmaceutical industry too much leverage over the FDA and has resulted in rushing drugs to market. But the FDA hopes that if Congress approves the plan, it will raise more than $6 million annually through “user fees” to review advertisements.
Although Congress may approve the plan, author Shreema Mehta says a range of public-interest groups, from ad critics at Commercial Alert to senior advocates at Gray Panthers, want an outright ban on all prescription drug advertisements. Public Citizen and Consumers Union warn that the FDA review of drug advertisements will likewise be tainted if funded by the very companies the FDA is charged with scrutinizing. Critics are calling for stricter regulations over drug companies and they say eliminating the financial ties between the FDA and the pharmaceutical industry should be the first step.
But the pharmaceutical industry is not the only industry that benefits from inconsistent FDA reviews and inadequate investigations of advertising claims. One of the nation’s biggest infant bottled water companies, Nursery Water, is misleading parents with erroneous information and false health claims on its website and in advertising materials, touting the safety and benefits of fluoride in infant bottled water, in clear violation of Federal Trade Commission (FTC) and FDA rules.
A letter sent from scientists at the Environmental Working Group (EWG) to officials at the FDA and FTC uncovers EWG’s extensive review of Nursery Water’s claims that both misrepresent the position of the American Academy of Pediatrics, which states, “supplementary fluoride should not be provided during the first six months of life” (AAP 2005), and contradict the official position of the FDA, which states, “the health claim [for fluoride] is not intended for use on bottled water products specifically marketed for use by infants” (FDA 2006).1
Mehta reports that representatives from the food and pharmaceutical industries say banning ads would violate the First Amendment. “In our system of jurisprudence we have a very high threshold that protects the right to free speech, whether it’s political or commercial,” Jim Davidson, attorney for the drug-company-funded Advertising Coalition, told the Associated Press.
Mehta warns of the increased leverage food and drug companies may have over the FDA should Congress approve the fee plan. She reports that in 2005, pharmaceutical companies spent about $4.2 billion in advertisements aimed at the public, known as “direct-to-consumer” ads, up from about $2.5 billion in 2000 and $1.1 billion in 1997. And the promoting of drugs to physicians, with almost $7.2 billion spent in 2005, dwarfs advertising to the public. At the same time, public spending on prescription drugs has steadily increased, reaching about $140 billion in 2001, more than tripling since 1990.
Meanwhile, Mehta reports that it’s not clear whether the FDA reviews most advertisements at all. The agency can direct drug companies to change their advertisements after they are released to the public if it finds they violate regulations, but does no screening before the release of ads that may be dangerously deceptive.
1. Anila Jacob, M.D., M.P.H. and Jane Houlihan, “EWG calls for Investigation of Nursery Water,” Environmental Working Group, February 1, 2008.
UPDATE BY SHREEMA MEHTA
Americans are taking more prescription drugs than ever before, leading the world in drug consumption and reaping huge profits for pharmaceutical companies. America is also one of the few countries that allow public advertising of prescription drugs. This is not a coincidence. Many doctors and consumer advocates have criticized advertisements featuring beaming people explaining how Valtrex changed their lives as deceptive, inaccurate, and invasive to the doctor-patient relationship. Many activists favor an outright ban on prescription drug ads; others call for strict regulation. This article dealt with the FDA’s ties to the pharmaceutical industry and its proposal to regulate what critics feel is dangerously deceptive advertising by charging drug companies to review their commercials.
A few months after this article ran, President Bush renewed the Prescription Drug User Fee, which includes the industry-funded review process of drug advertisements, putting into effect what critics argue is yet another conflict of interest in the agency.
Though the Washington Post ran several articles on PDUFA, few explored the importance of the new proposal for company-funded advertisement regulation. Though press coverage of the problems of drug advertising is slim, advocacy groups remain active on the issue.
Commercial Alert runs a prescription drug ad campaign that is currently working to raise support for the Public Health Protection Act, which would ban drug ads designed for the public. They are on the web at http://www.commercialalert.org/. The Consumers Union also supports this bill. Learn more about their campaign at https://secure.consumersunion.org/site/Advocacy?JServSessionIdr009=vjqvq0rk51.app44a&cmd=display&page=UserAction&id=1889.