Suppose a new drug were being evaluated for approval, but the FDA thought maybe a few restrictions were in order. Those restrictions being:
- The doctors must be able to handle complications which would be expected in 5 - 8% of patients,
- The doctors must be trained in identifying a certain medical condition which would make it dangerous for the patient to take the drug,
- The doctors must be trained in providing follow-up care in case something went wrong with the drug, and should have admitting privileges at a nearby hospital.
Sound fair?
Or do they sound like "draconian restrictions"?
If you're Senator Barbara Boxer (Duh, CA), these are "barriers," and she and the other Congressional D's successfully insisted upon their removal.
