FDA Delay Likely Killed Thousands, Imposed Billions In Costs

The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test “holds the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune notes, the FDA’s delay in approving the home HIV test is a “scandal.” It likely caused the deaths of thousands of people, given the mortality rate from AIDS.  It may also have caused billions of dollars in additional costs for taxpayers, given that AIDS is a costly and debilitating disease to treat, resulting in treatment costs of perhaps $600,000 per AIDS sufferer.

The FDA is also thwarting the production of certain life-saving drugs. The Obama administration also sought to restrict the market for bone-marrow transplants, potentially costing thousands of lives. It tried to convince a federal appeals court to extend the reach of the National Organ Transplant Act beyond its text, in order to ban compensation needed for the collection of peripheral blood stem cells. The federal DEA recently caused shortages of the drug Adderall, which is needed by narcolepsy sufferers. Earlier, government regulations caused cancer and burn victims in the Third World to die in agony without any pain relief.