This data would be especially useful to generic producers which need only demonstrate through such data that their product is therapeutically equivalent to the original (bio-equivalency).
The therapeutic options for these patients have recently increased with therapeutically equivalent, but longer-acting medication(s) becoming available [ 3].
The step-wise use of medications commonly referred to as step-therapy is a pharmacy administration interventional tool employed to encourage the use of purportedly therapeutically equivalent, but lower-cost medications from the same or different therapeutic classes.
Generic versions of brand-name drugs typically cost less, but federal officials say they are therapeutically equivalent.
The goal was to minimize confusion and dispel any doubt that a generic was therapeutically equivalent to the brand-name drug.
The company said it was concerned that gradually reducing distribution would cause many patients to unnecessarily switch to other products that it said were not therapeutically equivalent to Synthroid.
Development of new formulations after the original testing of any drug requires demonstration that the compounds are therapeutically equivalent and additional efficacy studies may not be required.
The F.D.A. said Sangcya was therapeutically equivalent to Novartis A.G.'s Neoral, its proprietary formulation of cyclosporine, which is projected to have worldwide sales of $1.3 billion this year.
"It is reasonable to assume that pancrelipase products sold by different manufacturers may not be therapeutically equivalent unless proved otherwise," the researchers said, adding that doctors should not allow generic subtitutions until the drugs were verified as equivalent.
Studies comparing pharmaceutical products from competing companies were typically short-term studies, designed for other purposes than health economic analyses, and, in general, did not use therapeutically equivalent dosing.
Mr. Dingell said F.D.A. tests indicated that none of the generic drugs from companies under investigation had posed a health or safety risk to patients, but he said that because of the wrongdoing uncovered so far, consumers could not assume that many generic drugs were therapeutically equivalent to the ones that they were imitating.
