How Generic Drugs Became A National Security Issue

 

If you’re on any medications, it’s likely that they are generic. In fact, generic medications now represent 90% of the prescriptions filled in this country.

It wasn’t always this way. In 1984, congress passed the Hatch-Waxman Act, which created a new regulatory track for generic drugs. Basically, they said as long as generic manufacturers could prove their drugs were bioequivalent to brand-name drugs, they could get quickly approved by the FDA.

But lately the generic drug market has been under heat as manufacturing has largely moved overseas, and some manufacturers have cut corners to compete on price. Meanwhile, Americans pay more for prescription drugs than other developed nations. I wanted to know more about the drug supply, so in this episode I interviewed my friend Hitha Palepu.

Hitha is a science communicator, a scientist, an angel investor, and a biopharma executive. She is the CEO of Rhoshan Pharmaceuticals, an early stage life sciences company developing injectable aspirin for coronary heart failure patients.

Topics we cover

  • The national security threat posed by US drug manufacturing moving overseas

  • How quality varies by manufacturing facilities

  • The key policies that have framed the pharmaceutical market

  • Why Americans pay significantly higher prices for prescription drugs

  • How we can encourage innovation of new drugs while bringing down the cost of prescription medications

  • Her vision for creating an essential drug registry

  • How the COVID vaccine showed the best of how the government and the pharmaceutical industry can work together to get important medications scaled and delivered as quickly as possible.

Listen

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