In 2010, the FDA discovered systematic fraud at a bioassay laboratory in Houston, Texas over a multi-year period. The fraudulent tests were used to assure the FDA about the safety and efficacy (and bioequivalence to name-brands) of hundreds of drugs on the US market. Despite this, the FDA did not pull a single drug from the market or notify consumers or physicians that there were problems with any of the crucial tests. (The EMA, on the other hand, pulled a number of drugs from the market.) Though the FDA nominally required drug makers to repeat, reanalyze or audit many of the relevant tests, of more than one hundred of drugs on the US market found to be affected, the FDA has only received some 50 repeats/reanalyses/audits, and has only reviewed 20 of those submissions. As a consequence, many drugs are still on the market without any valid trial that demonstrates safety, efficacy or bioequivalence.
