The Food and Drug Administration says it has “grave concerns” about the quality of many of the drugs currently in development, including the ones intended to combat the pandemic.
The agency, which is looking into how many of these drugs are safe, said in a statement Tuesday that it is “confident” that some of the medications currently being developed are safe.
But it said there are “grave” concerns about the “quality and safety” of a few of these.
FDA Commissioner Dr. Julie Foltin said in the statement that the agency “strongly urges” manufacturers to stop producing these drugs.
The FDA issued the statement in response to an article in the Wall Street Journal in which FDA officials said the agency was not taking action to regulate the production of drugs.
“The FDA has serious concerns about how drugs that are under development and are awaiting approval are being manufactured and distributed, and is considering its next steps regarding those drugs,” Foltins said in Tuesday’s statement.
She said the FDA is concerned about “a shortage of data on the safety and efficacy of these medicines” and said that “as a result, the agency is taking action.”
The FDA has already halted the sale of some of these medications.
In December, the FDA approved two drugs to treat the common cold.
But Foltinson said in her statement that those drugs, known as “mild seasonal influenza vaccine” and “mixed influenza vaccine,” do not meet FDA standards for “safety and efficacy.”
The agency also warned that it “strongest urges” pharmaceutical companies to stop marketing the two drugs, and it’s urging them to stop making them.
Foltiner said the government is also considering “an action plan to address concerns about potential safety issues” with some of those drugs.
Folsom’s statement comes after the Food and Agricultural Organization of the United Nations (FAO) warned that “there is a serious risk that some new drugs could be mislabeled as influenza vaccines and marketed as if they are influenza.”
FDA officials have not said what type of drugs the agency has concerns about.
The WHO said last week that there were a total of 14 drugs approved in the last five years for the treatment of mild seasonal influenza.
They were all approved to treat seasonal flu.
Folks at The Hill said they think FDA officials will “get into the weeds” and say more about the safety of these newer drugs, but they say they’re not sure how many FDA officials are aware of the FDA’s concerns.
The Hill also asked Foltini to comment on the FDA agency’s concerns about a “crisis” in the food industry.
She responded by saying FDA officials “are not interested in the specifics of the crisis, but are focused on the needs of consumers.”
“The agency is not going to tell people what they should or shouldn’t eat or drink, but it is going to make sure that consumers can understand that these are medications that have been approved for use in the past,” Foltson said.
FOLTSON: FDA wants to know what the FDA wants in these drugs and what the benefits are of those medications Foltina said she believes the FDA has a “responsibility to do its job.”
The company says that FDA has “great concerns” regarding some of its drugs and is “considering its next actions.”
FDA said the drug approval is “expected to have a broad range of benefits for the consumer and the environment, including protection against influenza and pneumonia, prevention of cardiovascular disease, and reducing the risk of influenza-related illness and death.”