Each year, about 2 percent of prescriptions are for drugs that have not been approved for safety and effectiveness. There were about 3.9 billion outpatient prescriptions in 2009, which suggests that about 78 million prescriptions were for unlicensed drugs last year.
But in the wake of a recent Food and Drug Administration effort to identify and remove unlicensed medications, that number may be declining. The crackdown, which began in 2006, has so far netted 500 unapproved drugs produced by 275 manufacturers, according to a Washington Post profile of FDA drug compliance director Deborah Autor.
Unapproved drugs are on the market for a number of reasons. Sometimes, a company has approval to market a drug, but rivals with similar medicines do not. Many drugs escape scrutiny because they entered the market before the FDA tightened its rules in the 1960s.
Autor’s team, however, found that companies had altered many old drugs so extensively that they had, in essence, become “new” and required a formal review and approval. Their dosages and formulations had changed, or label recommendations targeted a different set of patients and ailments.
