Drug companies drop the ball on safety studies

WASHINGTON - Drug companies have yet to even begin nearly two in three of the follow-up studies they agreed to undertake once their medicines were on the market, according to a government tally released Friday.

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Dr. Jerry Avorn, a Harvard Medical School professor and author of “Powerful Medicines,” in which he criticizes the FDA’s post-marketing system, said the numbers show the system is broken.

“This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven’t even been started yet,” Avorn said.

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Sen. Charles Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn., introduced legislation last year that would give the FDA added authority to require drug companies to carry out studies of their drugs once they’ve been approved and are being sold.