Published March 7, 2011 in Washington Drug Letter
Furthering its goal to remove unapproved prescription drugs from the market, the FDA has ordered that drugmakers stop manufacturing hundreds of unapproved cough, cold and allergy medications.
CDER Compliance Director Deborah Autor cited safety and the unreliability of final product as the chief concerns for the agency’s move. “We don’t know what’s in them, how they work or how they were made,” she said in a teleconference Wednesday.
However, at least one drug maker ordered to stop manufacturing its unapproved drug say they were “surprised” by the FDA’s action, adding that the products’ efficacy and safety has been confirmed for years by physicians.
The agency ordered companies to stop making the drugs in 90 days and halt shipping the drugs in 180 days. The FDA lists on its website the impacted medications — more than 500 in total — that contain 27 active pharmaceutical ingredients (API).
Autor said the FDA has received a “handful” of adverse events regarding the unapproved cold and cough drugs the agency is removing from the market. “We believe the adverse events are under reported,” she noted.
For example, some products marketed as “time-release” drugs actually released 85 percent of their API in the first 30 minutes after ingestion rather than over 8 to 12 hours as labeled. Testing in young children is also insufficient, she said, and some drugs the FDA lists contain two antihistamines, which could lead to over dosage.
Some products Autor mentioned during the teleconference were Qualitest Pharmaceuticals’ Cardec DM (phenylephrine), ECR Pharmaceuticals’ Lodrane 24D (brompheniramine) and Meda Pharmaceuticals’ Organidin (guaifenesin).
Drugs Widely Used
Davis Caskey, vice president of pharmaceutical operations at ECR, said many of the drugs mentioned by the FDA have been “widely used with minimal if any safety issues associated with them.”
“Safety wise, I don’t know of any reasons to have any of these products recalled,” Caskey told WDL. He added ECR collects and reports adverse events on the unapproved products to the FDA the same as with approved drugs.
Caskey disputed Autor’s comments that the agency doesn’t know what’s in the unapproved products or how they are made because the company’s site is routinely inspected.
ECR had recently requested a hearing with the FDA regarding its unapproved products currently on the market after the agency placed a call for such hearings in January. “And no action has been taken on those hearings,” Caskey said.
However, the FDA also announced Wednesday it would withdraw all outstanding hearing requests, according to a notice in the Federal Register.
Recently, the FDA has taken dramatic steps to curb the manufacturing and sale of unapproved drugs. Wednesday’s move is the 17th action in the FDA’s Unapproved Drug Initiative, a safety program launched in June 2006 to remove unapproved drugs from the market.
Just last month, U.S. Marshals seized a prescription ear-infection treatment from a Deston, Fla., company, saying the drug was unapproved (WDL, Feb. 21).
A list of the drugs impacted by the FDA’s action is available at www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/
SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm. — David Pittman