Jon Entine: FDA Balances Costs, Patient Safety in the Biologics and Personalized Medicine Revolution

Will it Get it Right or Damage the ‘Miracle’ Industry?

Sometimes what you see is not all you get. Just ask Nancy Pelosi, the House Minority Leader who two years ago uttered the now infamous words, “We have to pass the [Patient Protection and Affordable Health Care Act] so that you can find out what is in it….” Whether or not you support healthcare reform, the implementation of any vast, complex legislation can result in unintended consequences.

That’s certainly the case when it comes to the emerging era of biologics—a new class of treatments made from living organisms. Most therapeutic drugs are made up of simple molecules mixed together. In contrast, “biologic drugs” are made from far more complex human or animal proteins. Rather than treating the disease’s consequences, biologics work by blocking diseases early in their development, in the immune system, and can be individually tailored to a the person taking the medicine—a revolutionary turn along the windy road toward our personalized medicine future.

Forbes

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