FDA Finally Gets Around to Approving New Cancer Vaccine


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Yesterday, the Food and Drug Adminstration approved the new prostate cancer vaccine, Provenge, developed by the biotech company Dendreon. The vaccine is created by exposing patients' immune cells outside the body to prostate cancer cells. The exposed immune cells are then injected into patients with the aim of priming the patients' immune systems to attack the cancer. Dendreon first submitted its vaccine to the FDA for approval in 2006, and a FDA advisory panel urged the agency to approve in March, 2007. It's wonderful news that people suffering from prostate cancer now have a new treatment option.

But as Frank Burroughs, founder of the Abigail Alliance for Better Access to Developmental Drugs noted in press release he sent out yesterday:

Today with the prostate vaccine Provenge now finally approved, we have YET another example of why we need lifesaving and life-extending changes at the FDA.  Provenge is the 17th drug or vaccine the Abigail Alliance has pushed for earlier access to and earlier approval of that is now approved by the FDA.

This is yet another reason we need Congress to pass the Compassionate Access Act, H.R. 4732.

There is NOT one drug or vaccine that the Abigail Alliance pushed for earlier access to that did not make it through the clinical trial process.

Burroughs' group wants patients to have access to promising new treatments before they are approved by the FDA.

Back in 1996, the Competitive Enterprise Institute issued this biting video on the "Deadly Effects of FDA Overcaution" portraying an FDA press conference in which the head of the agency announces the approval of a new drug that will save 8,000 lives per year. The video then asks:

If the government approves a drug that will start saving lives tomorrow, then how many died yesterday waiting for the government to act?

For more on the Abigail Alliance's fight for faster access to new drug treatments see my 2007 column, "Whose Life Is It Anyway?"