ZOLADEX LA SWITCH INDUCEMENT BY U.K. DISTRIBUTOR TRIGGERS "CLAMP-DOWN" BY BRITISH REGULATORY AGENCY ON GIFTS, REPRISING U.S. ACTIONS FROM 1986-1989

Zoladex to Zoladex LA incentive switch promotions in the U.K. were undertaken without the agreement or support of Zeneca, the company said July 30. Zeneca "does not approve the use of such incentive schemes in the promotion of its products," the firm declared.

Earlier this year, Farillon, a distributor of Zeneca products in the U.K., was offering a "Zoladex LA prize draw" to general practitioners in Britain for moving patients from the original one-month implant formulation of the prostate and breast cancer agent goserelin acetate to the more recent three-month formulation. Zoladex LA is the U.K. brandname for Zoladex 3-Month, which entered the U.S. market during the first quarter of 1996.

In an advertisement to U.K. doctors, Farillon announced a "QUARTERLY PRIZE DRAW" among doctors switching "suitable" Zoladex patients to the three-month implant formulation. The winning entry was worth [pound]1000 while second and third places received [pound]100 and [pound]50 department store gift certificates, respectively. Farillon also announced that "any practice initiating a STANDING ORDER for ZOLADEX LA will be sent a FREE bottle of wine."

Farillon contends in a July 31 statement that the Zoladex LA promotion "had been approved by the head of the [Royal College of General Practitioners'] ethics committee." The company added: "the promotion was, in fact, withdrawn earlier this year and Farillon has taken steps to halt the promotion."

Zeneca emphasizes that Farillon is an "independent wholesale dealer company which is wholly distinct, separate and unconnected to" Zeneca. According to the Zoladex manufacturer, Zeneca learned of the promotion in "mid-1996," and asked Farillon to discontinue it. The wholesaler, Zeneca stated, reintroduced the offer "without any reference to Zeneca" following "increasing commercial pressure from competitors."

The U.K. Medicines Control Agency is paying closer attention to inducement campaigns for pharmaceuticals in a reprise of a similar regulatory effort by FDA, the HHS Inspector General and several state attorneys general in the U.S. during the period of 1986-1989.

"The use of gifts and inducements for the promotion of medicines to persons qualified to prescribe or supply is raising considerable concern," the U.K. Medicines Control Agency warned pharmaceuticals manufacturers, wholesalers and trade associations in a July 24 letter.

A July 28 follow-up statement from the U.K. Department of Health announced a "clamp-down on pharmaceutical companies and wholesalers who offer gifts and inducements to health professionals who prescribe or supply medicines." In cases where the promotional activities persist, MCA will issue warning letters to violating companies, the agency stated. Non-compliance could lead to prosecution resulting in fines of up to [pound]5,000, MCA noted.

The most visible of the precursor programs in the U.S. which drew criticism at the end of the last decade was a so-called "frequent prescriber" plan in which Wyeth-Ayerst offered airline tickets to doctors who prescribed a long-acting brand of propranolol (Inderal LA) to 50 new patients.

The Massachusetts attorney general challenged the program and eventually reached a $195,000 settlement agreement with the company in 1989, two years after the program was discontinued. The program was also highlighted in testimony by Health Research Group Director Sidney Wolfe, MD, at a Senate hearing on drug industry promotional practices held by Sen. Kennedy (D-Mass.) in December 1990.

The recent U.K. interest in inducements to doctors to switch to a newer brand arises from a complaint lodged by a general practitioner in February against Zeneca and Farillon with the Prescription Medicines Code of Practices Authority.

The GP called the Zoladex LA promotion "offensive," according to a PMCPA summary report. The PMCPA panel ruled in March that Zeneca had not breached the Code because it was uninvolved in the prize draw; the panel declined to rule on Farillon because the firm is a wholesaler and not under PMCPA authority.

PMCPA is a pharmaceutical industry self-regulatory panel affiliated with the Association of the British Pharmaceutical Industry. ABPI said it "welcomed" MCA's plan "to take stringent action against pharmaceutical companies and their representatives who offer unacceptable `sweeteners' to doctors and pharmacists."

MCA's interest in pharmacist promotions could affect generic campaigns in the U.K. The British Generic Manufacturers Association urged MCA to recognize the different promotional activities for branded pharmaceuticals and generic products. BGMA maintains that the marketing of generic drugs is "directed to the pharmacist and has no impact upon the medicine which the patient receives."

While BGMA said that in general it was supportive of a crackdown on pharmaceutical firms attempting to influence physician prescription practices, the trade group believes MCA should not focus on promotion campaigns designed to distinguish between sources of the same drug.

"The government has not sought to distinguish in its announcement between the clinical decision of doctors about which medicine a patient should receive and the commercial judgment which the pharmacist must make in the case of generic medicines about from where he or she buys that particular medicine," BGMA said.

BGMA's comments were similar to those submitted to MCA by the trade group in late May following the publication of a story in the British lay press that questioned the propriety of generic manufacturer promotional inducements. The marketing activities of generic manufacturers "are designed solely to influence the pharmacist or wholesaler in his decision of from where to source" a prescribed product, BGMA contended. The association is scheduled to meet with the MCA at the beginning of August to discuss the proposed "clamp-down."

The British generic drug association maintains that "the marketing and promotional activities of the generic sector...were never intended to fall" within the realm of the European Economic Community medicines advertising regulations implemented by the European Economic Community in 1994. Those rules outlaw the "supply, offer or promise [of] gifts, pecuniary advantage or benefits in kind as an inducement to prescribe or supply medicine."

Two cases cited by MCA involved promotional materials supplied by generic manufacturers and distributors targeting pharmacists. The agency highlighted Essex, England-based Norton Healthcare Ltd., an Ivax subsidiary, for its "Norton Advantage Collection," a catalog distributed to pharmacists.

Members of the Norton program receive a membership card with a PIN number, and accrue "advantage credits" for "every order...place[d] for Norton products, either directly with Norton Healthcare Limited or through a Norton Advantage participating wholesaler," according to Norton's catalog. Credits can be applied towards future orders "from the entire Norton Healthcare range," redeemed for prizes such as portable televisions, video recorders or bicycles, or exchanged for gift certificates or travel vouchers.

APS/Berk, a generic pharmaceuticals manufacturer based in Leeds, England, also was cited by MCA. APS/Berk provided a catalog for pharmacists, "The Voucher Exchange," offering office and home supplies including fax/answering machines and microwaves.