BusinessWeek: July 1, 1991

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THE FDA IS GROWLING AT DRUGMAKERS, TOO

In the go-go 1980s, when regulators slept, drug marketers let their imaginations go. They concocted clever strategies for boosting sales, from advertising prescription drugs directly to consumers to hosting "symposiums" for doctors in exotic locales. One gambit was based on the fact that physicians are free to prescribe drugs for uses not approved by the Food & Drug Administration. Once a drugmaker got the agency go-ahead to sell a product to treat a minor form of cancer, say, it then told doctors about additional studies demonstrating the treatment's efficacy for other types of cancer. Presto: big sales.

Those freewheeling days are coming to an end. Under new Commissioner Dr. David A. Kessler, the once-toothless FDA has a fearsome new set of fangs. In addition to his well-publicized attack on misleading food labels, Kessler is targeting what he sees as questionable advertising and promotion by the drug industry. So far, the FDA has cracked down on a handful of companies that were promoting drugs for nonapproved uses(table). Up to a dozen more cases are under investigation. "Promotional practices have, to be blunt, gotten out of hand," Kessler told pharmaceutical company representatives at the annual meeting of the not-for-profit Drug Information Assn. on June 17. "The current excesses must stop."

SIN OF OMISSION. Kessler's message is already sending tremors through the drug industry. "There are many companies that are pulling back from promotional programs they were planning to launch," says Joy Scott, chief executive of Scott-Levin Associates, a drug-marketing consultant in Newton, Pa.

Take the case of Ciba-Geigy Corp.'s gallstone-dissolving drug, Actigall. The company's marketing mavens had the idea of advertising in women's magazines and newspapers. But in Kessler's eyes, the ads are guilty of a sin of omission: They don't mention that a new type of minor surgery can often solve the problem in far less time. Ciba-Geigy says it has halted the campaign.

The FDA's strongest actions to date have been taken against industry promotions of unapproved uses for drugs. Such promotion isn't necessarily just a sales-boosting ploy. In treating many types of cancer, physicians depend on drugs approved for other forms of the disease. Half of all cancer drugs are prescribed in this "off-label" way. While these uses may help patients, the law bars companies from promoting or advertising them.

That hasn't stopped drugmakers from trying. Industry experts estimate that more than half of all pharmaceutical companies push unapproved uses. Mar

keting experts, for example, say that Eli Lilly & Co.'s representatives are quietly telling doctors about new studies showing that Prozac, its popular depression-fighter, is also an effective treatment for obesity. These experts also contend that Upjohn Co.'s sales staff is pointing to studies that show the company's baldness drug, Rogaine, will promote hair growth in women, a use not yet approved. Both companies insist that their sales teams are forbidden to mention unapproved uses. So far, the FDA hasn't taken action.

LONG PROCESS. Bristol-Myers Squibb Co. hasn't been so lucky. The company had been sending doctors a magazine, Oncology Commentary, which published studies showing that the firm's cancer drugs had lots of nonapproved uses. FDA officials pointedly told Bristol-Myers that the magazine was clearly "promotional literature in the guise of a scientific journal." In a May 10 settlement, the drugmaker agreed to kill the magazine. Johnson & Johnson also fell under the FDA's watchful eye. J&J sponsored a press conference to publicize a study--since shown to be at best inconclusive--demonstrating that its acne drug, Retin-A, also combats wrinkles. The FDA has given the case to the Justice Dept. to review for possible prosecution for violation of federal drug laws.

The FDA is also taking a look at other common industry practices, such as buying supplements to medical journals or paying for conferences. "What has grown dramatically are promotions that are disguised as something else, such as symposiums that look like traditional medical conferences but are sponsored by the maker of a drug," says Ann M. Witt, head of the FDA's drug marketing office. In 1988, 16 drug companies spent more than $85 million to sponsor 34,688 symposiums, up from only $3 million for 4,275 conferences in 1976.

Critics say the FDA's snail-like drug-approval process is partly to blame for widespread off-label use of drugs. If the FDA bars companies from telling doctors about new studies, oncologists say, cancer patients will suffer. "The FDA should go after cholesterol claims on food," says Dr. Gerald P. Murphy of the American Cancer Society. "But if they want to regulate the drug industry, they should get on with their own homework and get drugs approved faster."

Not to worry, says the peripatetic Kessler. The FDA chief says that he's working on a series of measures to speed new drug approvals, and that the results are already being felt. But for companies pushing the boundaries of drug promotion, Kessler is transforming the go-go `80s into the go-slow `90s.



TARGETS OF THE FDA CRACKDOWN
Company     Drug              FDA objects to
            Approved use      promoting these uses:
COLLAGEN    Collagen          Making lips fuller
            Acne scars
JOHNSON &   Retin-A           Combating wrinkles
JOHNSON     Acne
ICN         Ribavirin         AIDS treatment
PHARMACEUTICALS Respiratory virus
DATA: FOOD & DRUG ADMINISTRATION


John Carey in Washington and Joseph Weber in Philadelphia
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