. Last Updated: 07/27/2016

U.S. Threatens Crackdown on 'Date Rape Drug'

WASHINGTON -- The pill is small, white and tasteless when dissolved in liquid. It is manufactured by Swiss pharmaceutical giant Hoffmann-La Roche Ltd. to treat severe insomnia.


The prescription sleeping aid is sold and marketed in 80 countries around the world, including many in Europe and South America, and is a strong revenue producer for the company, although the drug manufacturer has never sought approval to sell it in the United States.


Yet in the United States, the pharmaceutical, known as Rohypnol, has been branded a "date rape drug" by police. This has led to calls for stricter penalties for those who possess it, and has placed the firm at the center of a debate pitting U.S. public policy issues against successful sales of the drug abroad.


Rohypnol has been called the date-rape drug because of a rise in sexual assaults that police suspect have been committed after the illegally imported drug was slipped into a victim's drink. The drug so incapacitates those who ingest it that they cannot resist sexual assault, and they often don't remember much of the attack later, police say.


Because of recent publicity surrounding the suspected rapes, the Drug Enforcement Administration, or DEA, and some women's groups are trying to get the drug reclassified on the DEA's controlled substance list to a Schedule 1 drug from a Schedule 4 substance.


Schedule 1 drugs include crack cocaine and heroin and essentially are defined as having no medical use, but a high potential for abuse. DEA officials said such a reclassification, and the stiffer legal penalties a Schedule 1 drug carries, would discourage the abuse of Rohypnol.


But including Rohypnol in a group with such drugs as heroin poses a big problem for Hoffmann-La Roche: Many countries use the U.S. controlled substance schedule to classify drugs sold within their borders. To identify a drug as having no medical use could suddenly make Rohypnol illegal in countries where it has been approved for sale for years and is used to help people with severe sleep problems.


The reclassification also could erode the estimated $100 million in annual revenue which the drug generates for the company and, officials said, tarnish the drug's reputation abroad.


"Yes, Roche is in the business of maximizing profits," said Donald Kaiser, an epidemiologist with Hoffmann-La Roche and spokesman for it on this issue. "But we're also in the business of protecting the company's products and reputation so that people and doctors who use our products continue to have confidence in those products."


The two views clashed in Congress this year, resulting in some intense lobbying and, finally, compromise legislation signed into law last month. The law stiffens penalties for use of any controlled substance, including Rohypnol, in a sexual assault, with up to 20 years in prison. Previously only Schedule 1 drugs were subject to the 20-year maximum.