Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling

[Avalux]

60. Holy Shit! This OP is sensationalistic crap.

There's some really good discussion going on in the thread, which shouldn't get lost in the weeds.

A generic drug company does not formulate drugs independently. They are ultimately not responsible for their product, which is, by federal law, a therapeutic equivalent to the original formulation.

So let's run through a simplified drug development/approval scenario, and subsequent generic formulation approval:

1. Merck develops a new compound for hypertension and files a new drug application with the FDA to perform testing on humans. In vitro and animal testing results support the application and they're granted approval to proceed.

2. Phase I clinical trials begin with healthy humans, strictly to determine if the compound is safe. If the compound passes this hurdle, it moves into Phase II clinical trials.

3. If Phase II are successful, the compound, now drug, moves into Phase III clinical trials, where large numbers of people with hypertension will take the drug to collect efficacy and additional safety data.

4. A lot of data is collected after many clinical trials are performed over years and years and submitted to the FDA. The FDA will approve the drug if they determine, based upon the data presented by Merck, that the benefits outweigh the risks.

5. A 17 year patent is granted to Merck, which prevents another drug company from copying it.

6. When the patent is set to expire, a generic drug company will take the original hypertension drug, copy it and make their own formulation.

7. The generic drug company then files an abbreviated new drug application with the FDA. Since all the "pre" work has been done by Merck, the generic drug company is only required to perform clinical trials to prove bioequivalency. Often, this is only one clinical trial with a relatively small number of people.

8. If the generic drug company can prove therapeutic equivalence (80-125%) to the original hypertension drug, the FDA approves the generic formulation.

9. The generic formulation is required to have the exact same labeling and safety profile as the original drug developed and marketed by Merck, because they (Merck) have performed the safety and efficacy clinical trials; not the generic drug company.

SO....the generic drug company is only responsible for proving their version of Merck's hypertension drug is therapeutically equivalent. They are not responsible for the safety or efficacy data, including post-market surveillance. The burden is on Merck to report the safety data, change the labeling if needed, then the generic company follows suit. The chemical name of both drugs is the same.

You may not agree with the ruling, but by law, that's how it works, and has for a very long time. As long as everyone involved is following the rules and isn't withholding or confounding data, it's actually a really good system.