June 24, 2013
By Greg Stohr
...The court (click here) in the earlier case said those suits are “pre-empted” because federal law requires generic-drug companies to copy the packaging inserts used by brand-name manufacturers. The court said it would be impossible for drug companies to comply with both federal labeling requirements and state-imposed duties to supply even stronger warnings.
Absolutely not. Generic drugs have similar but not the same formulation as drugs produced under trade names. The federal law has to change to demand the formation by generic manufacturers be determined and published with the drugs they sell.
This case should have been the impetus to that change, but, instead the Supreme Court decided life and limb of the American people are marginally better for generic drugs to be as cheap as possible including cutting corners on safety.
No one using generics expects to put their lives on the line for formulations UNKNOWN to the consumer.
This decision basically states the lower cost of drugs has greater benefit than the side effects of not knowing the formations of the generic. It is gambling again with the health of the American people.
This is not that expensive. Independent labs can determine the formulations of the drugs and printers will be more than happy to typeset the information. The inserts are being printed anyway. Generics should also have quality control. They may not need the intense quality control of trade named drugs, but, quality control should exist. That isn't that expensive either. It means hiring one person per shift to collect the 'batch' sample and send it to an independent lab. As soon as a new batch is started then the process has to be repeated. These costs are very marginal in assurance to the American consumer.
Physicians can prescribe the medications with greater confidence if these measures are accomplished.
By Greg Stohr
...The court (click here) in the earlier case said those suits are “pre-empted” because federal law requires generic-drug companies to copy the packaging inserts used by brand-name manufacturers. The court said it would be impossible for drug companies to comply with both federal labeling requirements and state-imposed duties to supply even stronger warnings.
Absolutely not. Generic drugs have similar but not the same formulation as drugs produced under trade names. The federal law has to change to demand the formation by generic manufacturers be determined and published with the drugs they sell.
This case should have been the impetus to that change, but, instead the Supreme Court decided life and limb of the American people are marginally better for generic drugs to be as cheap as possible including cutting corners on safety.
No one using generics expects to put their lives on the line for formulations UNKNOWN to the consumer.
This decision basically states the lower cost of drugs has greater benefit than the side effects of not knowing the formations of the generic. It is gambling again with the health of the American people.
This is not that expensive. Independent labs can determine the formulations of the drugs and printers will be more than happy to typeset the information. The inserts are being printed anyway. Generics should also have quality control. They may not need the intense quality control of trade named drugs, but, quality control should exist. That isn't that expensive either. It means hiring one person per shift to collect the 'batch' sample and send it to an independent lab. As soon as a new batch is started then the process has to be repeated. These costs are very marginal in assurance to the American consumer.
Physicians can prescribe the medications with greater confidence if these measures are accomplished.
