Ex-FDA officials: U.S. drug import oversight “grossly inadequate”
Ex-FDA officials: U.S. drug import oversight “grossly inadequate”
Two recently retired U.S. Food and Drug Administration officials told a House subcommittee on Thursday that the federal government’s poor oversight of drug imports and failure to sufficiently inspect overseas manufacturing plants provides a sieve for bad medicine to enter the country.
“The short answer — the current paradigm is grossly inadequate, is held together by bailing wire, and is incapable of determining and verifying the safety and efficacy of most imported drug products,” testified Carl R. Nielsen, a retired FDA director of the Office of Regulatory Affairs Division of Import Operations and Policy, before the House Committee on Energy and Commerce’s oversight and investigations subcommittee. “Product liability is protecting us more than FDA’s oversight of the international supply of pharmaceuticals.”
Nielsen, who now works as a self-employed regulatory consultant, warned the subcommittee that the FDA’s organizational structure and administrative processes are “entrenched in overseeing the domestic industry while largely ignoring the foreign industry.”
It’s estimated that about two-thirds of U.S. pharmaceuticals have chemical components made overseas, predominantly from Chinese and Indian suppliers.
“FDA’s inspection rate for imported drugs (and drug ingredients) when they arrive at a U.S. port is around 1 percent, which means that the vast majority of imported drugs do not receive an FDA inspection upon entry into this country,” said William K. Hubbard, a former FDA associate commissioner, who now represents the Coalition for a Stronger FDA.
“The chances of an imported drug being sampled and tested at entry to this country is even lower; in fact, of the millions of drug shipments arriving from foreign countries last year, only 340 samples were taken for laboratory testing,” he said.
U.S. lawmakers are concerned that drugs made by unscrupulous overseas manufacturers may carry harmful or deadly ingredients, such as the case of the recent substitution of ethylene glycol (antifreeze) for pharmaceutical grade glycerin in an elixir that was linked to 46 deaths in Panama, as well as to other deaths in Nigeria, India, South Africa and Argentina.
The World Health Organization has reported in some areas of the world, especially in parts of Africa and Asia, that more than half of the pharmaceutical supply is counterfeit. Within China, considered by many industry experts to be the ringleader of counterfeit drug production, the number of deaths from counterfeit and substandard drugs is reportedly between 200,000 and 300,000 a year.
Both former FDA officials said the agency risks losing its international “gold standard” status for determining drug safety, if Congress fails to provide funding to significantly increase the FDA’s staff and information technology dedicated to import drug oversight.
The Government Accountability Office, a congressional watchdog agency, cited in a report released this week that the FDA inspects about 7 percent of overseas pharmaceutical manufacturing sites a year. “At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection,” the GAO said.
Internal FDA estimates of foreign drug and related chemical producers remain unclear largely due to unlinked, outdated computer systems. The GAO’s study found that FDA registered 3,000 to 6,800 establishments.
“The agency should put more value into knowing the compliance status of the entire foreign industry as thoroughly as it pursues the compliance of the domestic industry,” Nielsen said. “If the agency knew the compliance status of the universe of foreign manufacturers, it would be able to develop appropriate strategies to better ensure only safe imported drugs are allowed entry into the United States.”
FDA Commissioner Andrew C. von Eschenbach told the subcommittee that his agency has carried out more than 200 foreign drug manufacturing inspections a year, but admitted that “exercising FDA’s regulatory authority abroad can be challenging.”
“In some countries, we need authorization from the relevant government to enter and inspect facilities, and other countries have travel alerts that require FDA to take special precautions to ensure the safety of our investigators,” von Eschenbach said in his written testimony. “Many of these firms are motivated to have FDA inspect their facilities because they have an application pending with the agency that may require a pre-approval inspection.” ' Chris Gillis