U.S. Expected to Allow Sale of Generic Valium

Health and Human Services Secretary Margaret M. Heckler is expected to announce today that Valium, one of the five best-selling and most-prescribed drugs in the nation, will be approved for marketing in generic form, industry and government sources said Tuesday.

The department’s action, taken under last year’s Drug Price Competition and Patent Restoration Act, will bring nine of the nation’s top 10 prescription drugs into the generic field, thus making them available at a substantially lower price to the consumer, sources said.

Officials at Hoffmann-LaRoche, which sold more than $240 million worth of the tranquilizer last year, said the company opposes the marketing of diazepam, the generic form of Valium, because it is not “bio-equivalent” to the original drug.

The company, which has sold Valium exclusively for nearly 23 years, petitioned the Food and Drug Administration earlier this year when its patent expired to deny approval to companies seeking to manufacture generic versions of the drug.

‘Terrible All Around’

“It is important to the public health that any generic copy be an exact copy,” said John Doorley, a spokesman for the company. “Otherwise, it’s just terrible all around for everybody--especially the consumer.”

But William Haddad, chairman of the Generic Pharmaceutical Industry Assn., said the two drugs are “exactly identical--there’s zero difference.”

Haddad predicted that, within the next four years, about 200 drugs would enter generic competition and that the generic market would increase to $4.5 billion from less than $1 billion.

“This is the first major, brand-name, popular drug to go generic,” he said. “Valium had become the symbol of the last wall of resistance to generic competition--and now it has crumbled.”

The only major prescription drug that has not been marketed in generic form is Tagamet, a medication to treat ulcers manufactured by SmithKline Beckman of Philadelphia. Tagamet’s patent does not expire until 1993.

Half of Current Price

The generic version of Valium initially will be sold at about half of its current price and eventually will drop to about 20% of the original cost, Haddad said. The retail price of Valium is about 30 cents for a 5-milligram tablet, and the average patient takes about three tablets a day.

The House Energy and Commerce subcommittee on health and the environment, which conducted a study of prescription drug price increases, said the price of Valium rose 81% between Jan. 1, 1981, and July 1, 1985, compared to a rise of 23.7% in the consumer price index.

“Usually, when a drug goes generic, the brand-name company raises its price to make up for the loss of its share of the market,” William Corr of the subcommittee staff said.

But Doorley, of Hoffmann-LaRoche, said he does not know if the price of Valium will rise to offset potential losses. “It depends on a lot of market factors,” he said.

A total of 25 million prescriptions were written in 1984 for oral Valium, he said. The drug also is available in an injectable form.

Doorley said his company’s petition to the FDA was based on tests conducted on two foreign generic diazepams that found that, “for up to the first two hours of administration, these generics did nothing for the brain.”

He added: “If you take Valium for fear of flying, or for detoxification of alcohol, and it doesn’t work for the first two hours, you’re in trouble. If speed of action is important, it’s necessary that the generic be equivalent.”

The Drug Price Competition and Patent Restoration Act, sponsored by Rep. Henry A. Waxman (D-Los Angeles), provides that brand-name drugs that entered the market after 1962 be subject to generic competition once their patents have expired. Pre-1962 drugs are already open to manufacture by generic drug firms.