US Plan For Literature On Unapproved Uses Of Drug

In a controversial move paralleling a request by pharmaceutical and medical device companies, Senator Connie Mack has introduced US legislation to allow the distribution of scientific literature on unapproved uses of drugs.

While the companies claim they only want to supplement the flow of scientific information to doctors, those opposed feel that lifting the current restrictions would both change the marketing of drugs and allow companies to avoid Food and Drug Administration approval procedures for additional indications for drugs already on the market. There is also some concern that drug company-produced information would encourage doctors to prescribe more drugs for uses that have not been fully tested for safety and efficacy, the Wall Street Journal noted.

"Left unchecked, the promotion of unapproved uses not only can expose patients to unnecessary risks," the FDA has said, "but also has the potential to undermine the product approval process." A major concern is that drug companies will not fully test drugs for additional indications, so that doctors have insufficient information. The agency is holding a hearing in October on pharmaceutical marketing (Marketletter September 4).