The FDA classifies certain generic drugs as being bioequivalent to the innovator drug. In other words, based on certain characteristics, these drugs are assumed to be absorbed in roughly the same way by the patient as the innovator drug is, resulting in the same efficacy.
Yet there is ample evidence that many medicines are not truly bioequivalent to the originator medicines they are supposed to imitate. As a result, switching between two allegedly bioequivalent medicines in some instances leads to vastly worse patient outcomes.
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In a new peer-reviewed paper we published this week in the journal Trends in Pharmacological Sciences, we analyze this non-bioequivalence problem for drugs to treat depression, organ rejection, heart disease and many other conditions and diseases. We trace the problem to myriad causes, but many stem from a lack of transparency of bioequivalence data collected by the FDA.
Part of the problem is that the FDA relies on out-of-date laws and regulations for assessing the quality of generic drugs and their bioequivalence to innovator products. Regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984 and urgently require modernization. Medication therapies have become substantially more complex over the three decades since passage of the Act, and a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process, as there is substantial clinical, professional judgment involved, and in some instances these decisions should be better informed. Lastly, pharmaceutical ingredients for finished products, and even the finished products themselves, are from multiple sources of supply and from numerous countries. This adds variability in their production, which may drive bioequivalence problems.
At the same time, drugs may be of poor quality due to shoddy manufacturing. This problem is acute because of the vast amount of ingredients and products made in India and China. As evidenced by warning letters issued to companies in these countries that have failed to comply with good manufacturing processes, both nations have poor enforcement of weak laws.
When these elements are viewed together, they clearly suggest an urgent need for more transparency and updated standards for bioequivalence.
Access the paper here.
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