FDA reprimands drug companies for ads

False, misleading claims being targeted

A lawsuit and countersuit between Zeneca Pharmaceuticals and Eli Lilly over advertisements and marketing strategies for Zeneca’s tamoxifen and Lilly’s raloxifene, two new drugs aimed at postmenopausal women, have shed light on the Food and Drug Administration’s growing oversight of direct-to-consumer ads. Print, broadcast, and radio ads by drug companies have increased, based in part on the easing of restrictions included in the recent FDA overhaul legislation passed by Congress.

As part of the paperwork filed in the lawsuit, each drug company included letters from the FDA accusing the other of producing misleading ads about the drugs. A review of files within the FDA’s division of drug marketing, advertising, and communications finds a host of FDA cautions, reprimands, and orders to rewrite or pull ads. Because the FDA is a federal agency, its documents are public record. The agency is empowered to conduct enforcement based on the federal Food, Drug and Cosmetic Act.

Ads were pulled voluntarily

The FDA cited Zeneca’s tamoxifen ads for a rewrite because the ads did not include the drug’s risks of blood clots and uterine cancer. Lilly was targeted because its ads implied that raloxifene can prevent breast cancer. Raloxifene was approved last year specifically as an osteoporosis prevention treatment, though much of the press surrounding the drug centered on additional studies of its success in early trials against breast cancer, an indication Lilly is pursuing for the drug.

Tamoxifen has been on the market for years as a breast cancer treatment, and last year it was granted an expanded indication for use in reducing the risk of breast cancer. Zeneca filed its lawsuit against Lilly in February, asserting that Lilly’s salesforce has been telling doctors its drug could prevent breast cancer and should be used instead of Zeneca’s tamoxifen. Lilly countersued in March accusing Zeneca of slander.

An FDA spokesperson says both companies voluntarily have pulled the ads following criticism by the agency. "It’s the obvious overstatement of a drug’s benefits and the understatement or lack of statement of its risks, the direct attack ads on competitors that fuel those fires, and some cases of promoting unapproved uses that we’re seeing more of and we’re going after," says the FDA spokesperson.

The FDA has the authority to screen ads before they are published or aired and can pull an ad or order "corrective" advertising in particularly egregious cases. In most cases, the FDA says, drug companies will rewrite or withdraw ads voluntarily. FDA oversight also can cover the tactics drug companies — and their advertising agencies — use to distract the public from the information they want to downplay.

For example, among the many actions taken by the FDA over the last year is a letter to Wyeth-Ayerst concerning its osteoporosis drug Premarin. The letter criticized the way a TV ad’s visual montage distracts viewers from the wording of the drug’s risks, which are required to be included, while a more sedate background runs behind the text describing the drug’s benefits.

Similarly, the FDA said a TV commercial for Pharmacia & Upjohn’s injectable contraceptive Depo-Provera mixed its audio and visual messages about the drug’s risks too awkwardly, "virtually assuring that consumers will have trouble fully comprehending any of the information."

Novartis was criticized for "false, misleading, unbalanced and incomplete" information in ads for its cholesterol drug Lescol, which did not speak to the warnings of the drug’s effect on the liver. Pharmacia & Upjohn was stung again by the FDA for an ad for Caverject, billed as an alternative to Viagra, because the ad did not state the drug required a direct injection into the penis.

Bristol Myers Squibb was notified to change its ads for Pravachol, used to reduce the risk of heart attack, because the ad featured visuals of female athletes, though the FDA says women were not included in the clinical trials on which that indication was based. A Glaxo Wellcome print ad for its herpes treatment Valtrex was cited as "false or misleading and lacking in fair balance" because it did not include common side effects found in trials.

The FDA also monitors how ads directly tout one drug over a competitor. In one case, the FDA sent letters to three antihistamine makers, Hoechst Marion Roussel (Allegra), Schering-Plough (Claritin), and Pfizer (Zyrtec), telling all three to stop saying their drugs were better than their competitors’. The FDA says that based on information it has from the American Association of Advertising Agencies, pharmaceutical manufacturers spent $1.3 billion on ads in 1998, up from $595 million in 1996.