WASHINGTON — Pushing ahead with its crackdown on ineffective prescription drugs, the Food and Drug Administration plans to yank about 500 unapproved cough, cold and allergy medications from the market.
The FDA said Wednesday that the class action is part of its Unapproved Drugs initiative. The affected products can’t be legally marketed in the United States, according to the agency.
Although the FDA requires companies to submit all new prescription drugs for scientific review before they are launched, thousands of drugs predate the agency’s drug regulations and have avoided scrutiny for decades.
Most of the drugs targeted by the latest action are pills using untested combinations of decongestant and cough-suppressing ingredients. Since most Americans buy cold medicines over the counter, the prescription medicines cited by the FDA represent a small part of the market.
"Removing these unapproved products from the market will reduce potential risks to consumers. We don’t expect this action to have a negative impact on consumers," stated Deborah Autor, director of the FDA’s office of compliance. "There are multiple other products available to treat cold, cough and allergy symptoms."
The FDA advises consumers who believe they are taking an unapproved prescription cough, cold or allergy product to contact their health care provider to discuss alternatives.
The agency said manufacturers that have not registered products with it must cease production and shipments immediately.
Among drugs listed by the FDA are such products as Pediahist, a cold formula labeled for patients as young as 1 month. FDA regulations do not recommend cold medicines for any children under age 2.
The agency noted that doctors may be unaware that they are prescribing unapproved drugs, because the products are often labeled just like FDA-approved products.
In 1962 Congress ordered the FDA to review all new medications for effectiveness, and thousands of drugs that were already on the market were supposed to be evaluated over time. But some manufacturers claimed their medications were grandfathered under earlier laws.
The FDA launched its latest crackdown on unapproved drugs in 2006 and has taken action against 17 types of medications and dozens of companies. In general, the agency orders manufacturers to stop making and shipping drugs, and it has seized millions of dollars worth of medications.
Still, federal law does not call for fines for selling unapproved drugs, and criminal prosecutions are rare.
