n n n ‘.concat(e.i18n.t(“search.voice.recognition_retry”),’n
WASHINGTON (AP) — When you buy eye drops at a store across the United States, you can assume you’re buying a product made in a clean, well-maintained factory that’s met the needs of fitness regulators.
But repeated over-the-counter recalls are drawing attention to how little U. S. officials know about the situation at some midway production plants around the world, and the limited equipment they have to interfere in cases. problem.
The Food and Drug Administration is asking Congress for new powers, adding the ability to order drug recalls and require eye drop brands to go through inspections before shipping products to the U. S. U. S. But experts say those functions will be dead without more staff and resources for inspections. , which was a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits.
“The FDA is doing its job in terms of quality control inspections of drugs overseas,” said David Ridley of Duke University and co-author of a recent paper on the slowdown in inspections. “Very few foreign drug brands have been inspected in the last four years. years. “
In 2022, FDA foreign inspections were down 79% from 2019, according to agency records collected by Ridley’s group. Inspections increased this year but are still far below pre-pandemic levels.
FDA spokesman Jeremy Kahn said, “The FDA strives for as much convenience as possible, but at the end of the day, the industry is to blame for the quality of its products. “
In October, two dozen brands of eye drops were recalled after FDA staff discovered cracked floors, barefoot staff and other unsanitary conditions at a Mumbai factory that supplied products to CVS, Walmart and other primary retailers. This is the first time an FDA staff agency had visited the site.
The inspection was due to a previous recall of infected eye drops from another Indian factory that has been linked to four deaths and more than a dozen cases of vision loss. This plant had never been inspected before.
“These are very rare cases, but what we noticed is that these products can cause genuine harm,” said Dr. Timothy Janetos, an ophthalmologist at Northwestern University. “Something has to change. “
Experts point to 3 conceivable changes:
PRE-INSPECTIONS
Prescription medicines are highly regulated. Before a drugmaker can sell one in the U.S., it must undergo FDA review to establish its safety and effectiveness. As part of the process, the FDA typically inspects the factory where the drug will be made.
But eye drops and other over-the-counter products are not subject to an initial review or inspection. Instead, they are governed by another formula called a monograph, necessarily a generic prescription for all drugs in a specific class. which are the popular recipe, they can launch a product within a few days of filing their application with the FDA.
“It’s not about electronic paperwork yet,” said Dr. Schulz. Sandra Brown of the Dry Eye Foundation, a nonprofit that advocates for more regulation. “There is no need for facilities to be inspected before shipping them for sale. “
The FDA says it has flexibility to adjust its review process “to ensure safety.”
But the agency is asking Congress for the power to require manufacturers of eyedrops and other sterile products to give at least six months notice before shipping products from a new factory. That would give inspectors time to visit facilities that aren’t on their radar.
It’s possible that some over-the-counter drug brands, which aren’t accustomed to pre-approval inspections, will oppose the proposal.
But Brown says the unique dangers of infected eye drops require more than just pills and tablets.
“Anything you ingest will find acid, which will kill as many bacteria as possible,” Brown said. “It’s much more harmful to put a product in your eyes. “
REMINDERS THAT REQUIRE
In late October, the FDA warned consumers not to use eye drops sold at CVS, Rite-Aid and other stores, but the products weren’t officially recalled until Nov. 15, about three weeks after their expiration.
In fact, the Indian manufacturer Kilitch Healthcare refused to cooperate in the first place. The FDA can impose recalls on food, medical devices and many other products, but it doesn’t have the same authority for drugs and will have to ask companies to act voluntarily.
The FDA recently asked Congress for authority to recall drugs.
FUNDING FOREIGN INSPECTORS
Since the 1990s, drug production has shifted to India, China, and other countries at lower costs.
The Government Accountability Office has raised concerns for years about the FDA’s oversight of the global supply chain, flagging it as a “high-risk” issue for more than a decade.
The FDA said in a statement that it is employing “all available tools” to ensure Americans get “high-quality, safe, and effective” drugs.
The company sometimes prioritizes plants that have never been inspected or have not been inspected in the past five years. It halted maximum-regime personal inspections abroad in March 2020 and did not resume them until 2022. The company did not conduct any inspections in India, the first year of COVID-19.
FDA officials have long said it’s tricky to recruit and retain inspectors overseas.
Experts say Congress can and should address that.
“Federal recruitment is inherently slow and salaries are not competitive,” said Ridley, a researcher at Duke. “Congress wants to help the FDA solve this problem and then hold it accountable for body inspections. “
___
The Associated Press Health and Science Department receives information from the Howard Hughes Medical Institute’s Educational and Scientific Media Group. The Palestinian Authority alone is guilty of all the content.