FDA faces similar calculations about the potential for aggravating drug shortages when it moves to shutter drug compounding operations that fail to meet standards. Congress recently enacted legislation that bolsters FDA's authority to crack down on violative compounders, while permitting legitimate operators to continue providing services to hospitals and patients. However, it's not clear that the new voluntary registration program will do much to curb the bad actors, unless purchasers steer their business to quality compounders.
Efforts to curb counterfeit and substandard drug distribution similarly require a tricky FDA juggling act to permit access to less costly medicines while blocking distribution of fraudulent products. Many Americans appear eager to order drugs from unknown sources that offer lower prices. Maine has even passed a law authorizing import of cheaper drugs from "Canadian websites," despite warnings that this could bring in ineffective and unsafe medicines. Consumers believe that unregistered online operators provide perfectly sound medicines, and that FDA controls merely reflect pressures from pharma companies to reduce low-cost competition.