The FDA has failed for decades to clearly establish enforcement policies related to pharmacy compounders because the agency doesn't want to concede that it was never supposed to have jurisdiction over the legitimate, local practices of pharmacy and medicine.

FDA regulation of the development and manufacture of drugs is a costly endeavor. It adds to the price of drugs. Politicians cannot simultaneously support increased regulation of drugs and then undermine safety goals when the same rules drive out cost competition, leaving only the more expensive versions available.

A recent decision by a federal trial court gave the Food and Drug Administration the latitude that the agency has long sought to regulate our cells as drugs. It could put the brakes on one of the most promising areas of medical research.

The FDA wants to regulate software used to support the decisions made by patients and health-care providers in the same way it regulates the software embedded in medical hardware such as X-ray machines and infusion pumps.

Until government price controls are lifted, the makers of generics will be unable to cover their production costs.

An aortic valve approved in Europe four years ago will soon be approved in the U.S. Meanwhile, thousands who may have benefited from the device have died.

We need to develop better models for doing clinical trials that are specifically geared toward generating comparative data.

Medicine will suffer if Washington controls the flow of scientific information.

Europeans are approving important new drugs more rapidly than we are.

Cellular intervention to slow aging is a science in its infancy. Will regulators keep it there forever?

Government-controlled vaccine development has left us scarily vulnerable.

The new medicine shows that we’re biochemically separate and unequal—and regulators are starting to catch on.

Brilliant doctors often work closely with big drug companies, and they seem to like their corporate partners just fine.

The new pharmacopoeia offers people too much knowledge and control for one-size-fits-all health care to cope with.

Diagnostic technology is on a collision course with the FDA.

Big drug companies shun some drugs and embrace others because, collectively, the FDA, doctors, patients, insurers, and juries push costs higher, and prices lower, on some categories of drugs and not on others, to the point where some make economic sense and some do not.