The Food and Drug Administration (FDA) has concluded that the pharmaceutical industry needs to adopt manufacturing innovations, partly to raise quality standards. In other industries, manufacturers constantly change their production lines to fine improvements. But FDA regulations leave drug-manufacturing processes virtually frozen in time. As part of the drug-approval process, a company's detailed manufacturing plan-- and even the factory itself--must obtain FDA approval. After approval, even a tiny change in how a drug is produced requires another round of FDA review and authorization that involves time and paperwork.

Quality testing is done by hand. Computerized equipment and robots are not used as

commonly as in other high-tech industries. Most pharmaceuticals are made

according to recipes that involve many separate steps, each step produces an

intermediate batch of chemicals that must be stored, sometimes for long

periods. Only then can the process move on to the next step. Gauging the

dryness of a batch requires a technician to stop a dryer, break a vacuum seal,

and pluck a sample by hand for testing in a specialized laboratory. Before the

concoction can move on, a worker might have to wait hours for test results.

Under the old system for testing for bacterial contamination, a scientist looked for

contamination by peering through a microscope to count colonies of organisms in

a petri dish.

How diminishing returns are likely to set in for the pharmaceutical production process when the FDA has so many guidelines of compliance and regulation?