jdreyer wrote on Dec 28, 2016, 13:17:
Big Pharma is not altruistic in the least. There are generics because the government sets the patent expiration for drugs at 20 years. Don't fool yourself: the drug companies salivate at Disney's 90 and 120 copyright expirations. And they develop slight modifications of existing drugs, market them and get approval as new drugs, and then sell them at the protected price even though they're not any better than existing drugs. And don't even get me started on Skreli or Epipen.
Fortunately they are one of the more heavily regulated industries, so the damaging aspects of capitalism are mitigated and they're able to provide an overall good. Could see that change under Trump, who wants to deregulate a lot of stuff. Wait until "market forces" come into play because of 100s of people dying from a bad drug.
Authorized generics are authorized by the pharmaceutical typically after their 180-day (3-year) exclusivity period. This is to allow them to recoup their costs for R&D and approval. This is precisely why in 2012 that aforementioned $180 30/day supply was now available to me in 30/day generic form for $10. In other words, I didn't have to wait 20 years for a generic to become available.
Regardless of regulation and Wall Street, the process of bringing a drug to market is strict. For example, pharmaceuticals need to file an Abbreviated New Drug Application (ANDA) with the FDA that seeks to demonstrate therapeutic equivalence to a previously approved "reference-listed drug." They must prove they can manufacture the drug safely and consistently. For an ANDA application to be approved, the FDA requires the bioequivalence of a generic drug to be between 80% and 125% of the innovator product. Additionally, the FDA adds the generic drug to its Approved Drug Products with Therapeutic Equivalence Evaluations list (ADPTEE) and annotates the list to show equivalence between the reference-listed drug and the generic. There are also laws and regulations that generic pharmaceutical companies must follow but the overall scope of these regulations is to protect the public. (Information gleaned from Wikipedia with references.)
That being said are their issues with gross misconduct? Absolutely. But this is the exception instead of the rule. For the most part, the FDA helps make medicine less expensive for all.
"There are times when I would rather have some Kahlua instead of a clue." - Mr. Tact (May 27, 2021)