FDA Pursues Delicate Balancing Act

Dec 01, 2013

Jill Wechsler
A number of high-profile regulatory issues challenge the Food and Drug Administration's ability to balance potential harm and benefits to patients—both from gaining access to new treatments and by addressing safety threats from misused or adulterated products. The public outcry over shortages of critical cancer therapies and intravenous solutions, for example, raises questions about whether FDA endangers consumers more by permitting violative products on the market—or by shutting down facilities needed to produce important therapies. FDA officials say they take every step to avoid a plant closure and work hard to identify alternate quality sources, but can't permit marketing of contaminated products—especially injectible therapies.

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.

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