We’ve written about the lack of accountability nationally around generic drugs before, but it’s time to revisit it. The Pop Tort just published a column on the updates surrounding legal accountability for generic drug manufacturers.
Generic brand drugs are not the same as brand name drugs. Pop Tort explains:
Those differences can affect what’s called bioavailability – the amount of the drug that could be absorbed into the bloodstream. As the American Heart Association recently noted, “Some additives traditionally thought to be inert, such as alcohol sugars, cyclodextrans, and polysorbate-80, may alter a drug’s dissolution, thereby impacting its bioavailability.”
Differences also occur because generic companies are not told how brand-name drugs are put together so they have to guess. The FDA is aware of this and allows for certain differences. As Fortune Magazine notes, the FDA’s “definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.”
Despite these differences, in 2011, the Supreme Court decided that generic brands cannot be held accountable for the problems their different drugs may create.
But this may change: The FDA has proposed a new rule to restore your rights as a consumer and restore parity between brand name and generic drugs.