Questions About FDA’s Drug Approval Process Answered

Is the road to FDA approval of a new drug as long and winding as it sometimes seems?

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less.

Consumer clarity on how certain products make it to market and whether they are safe is lacking, so much so that some are left wondering whether the FDA is being overpowered by “Big Pharma.” The issue is the focus of a Living Safer Magazine cover story.

“Admittedly, there’s not much in the way of studies to disprove that the FDA is doing its job,” writes Stephanie Andre in an article titled “The ABCs of the FDA Approval Process.” “Yet, one still feels as though the agency could slow down the process, instead of giving way to notions that drug companies can buy their way toward faster approvals, thereby shortening up clinical trials and never fulling understanding the long-term effects of such medications.”

At first, the drug-approval process seems cut-and-dried. Companies developing new prescriptions test them on animals to determine initial efficacy, then conduct clinical trials on humans to measure outcomes relating to specific diseases. The next step involves filing a New Drug Application, or NDA, with the agency. If the drug is made from biological elements as opposed to chemicals, another form called a Biologics License Application, or BLA, is submitted. Both documents contain test results, details on product manufacturing and contents of the label.

“The label provides necessary information about the drug, including uses for which it has been shown to be effective, possible risks, and how to use it,” Andre writes. “If a review by FDA physicians and scientists shows the drug’s benefits outweigh its known risks and the drug can be manufactured in a way that ensures a quality product, the drug is approved and can be marketed in the United States.”

But what about the risks? How much is known about them? Such questions might be prompted by the fact that the FDA does not conduct any testing. The agency instead relies on results from the sponsor seeking approval and occasionally vets the data through its Center for Drug Evaluation and Research, or CDER. The advisory committee is called upon when there are varying degrees of uncertainty about the drug, said Dr. Mark Goldberger, a former CDER director.

“Some considerations would be if it’s a drug that has significant questions, if it’s the first in its class, or the first for a given indication,” Goldberger said. “Generally, the FDA takes the advice of advisory committees, but not always. Their role is just that – to advise.”

Patients have both the responsibility and the right to gauge the safety of prescriptions they take, and the FDA acknowledges that by providing a list of “Frequently Asked Questions about the FDA Drug Approval Process” on its Web site.