Sammies finalist fights unapproved drugs

By Rachel Stevens
Federal News Radio

Most people assume that every medication on the market has been thoroughly vetted by the federal government.

But in reality, hundreds of prescription drugs make it to the market every year without FDA approval.

Many of these have dubious value.


Some are even outright dangerous.

That’s exactly what Deborah Autor is trying to stop. Autor is the director of the Office of Compliance at the Center for Drug Evaluation and Research at the FDA and a finalist in the Citizen Services category of the Service to America medals (Sammies).

Autor says the problem is wide-spread. There are thousands of drugs on the market that lack FDA approval. Some are even being given to children.

“These products are out there. They are advertised to doctors in journals, they are brought to doctors’ offices by detail salesmen, they are put in the physicians’ desk reference,” she explains.

In order to change this, Autor and her team designed a program that combines aggressive enforcement, incentives, outreach programs and consumer and manufacturer education.

“We decided this is the time, once and for all, to try to solve this problem,” Autor says.

She names narcotics and prescription cough and cold treatments as some of the biggest offenders.

But Autor says she does not want to take away medications people rely on. The campaign is not aimed at forcing doctors to stop prescribing, or people to stop taking, certain drugs.

“What we want is for people to be aware that this is a problem, and for the companies to come in and bring to the FDA the evidence that their products are safe, effective, and adequately manufactured,” Autor says.

The Service to America Medal is an award recognizing excellence in federal civil service. It is given out annually by the Partnership for Public Service. Read more of Federal News Radio’s Sammies coverage.

Rachel Stevens is an intern with Federal News Radio.