Effective overseas inspections are key to ensuring drug quality

Effective overseas inspections are key to ensuring drug quality
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Americans assume their generic drugs are safe, effective and cheaper versions of name brand drugs. The problem is that the assumption is right, until it is wrong.

Reports from mainstream news outlets such as NBC News have found that drugs manufactured in overseas locations such as China and destined for American consumers have been tainted, sometimes with chemicals that cause cancer. While several former Food and Drug Administration (FDA) inspectors have attempted to sound the alarm, warning consumers that generic drugs manufactured in China and India may be less than pure, the system set up to police these overseas manufacturers continues to fail.

To be clear, generic drugs aren’t bad, even if they are manufactured overseas. But over the past two years the FDA has approved more than 1,600 new generic drug applications, presenting a major challenge to safeguard such medications. An effective FDA inspection regime is key to ensure consumers receive safe drugs at the pharmacy counter and to end the recent waves of generic drug recalls.

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The FDA inspectors who conduct overseas inspections are highly educated and qualified, but often pressed for time and impeded by language barriers. They are sometimes also frustrated by senior officials within the FDA who sometimes cover for overseas manufacturers, overruling recommendations from inspectors to delay new approvals to produce U.S. drugs until conditions improve and instead opting to allow manufacturers to voluntarily fix problems uncovered on site.

Overseas facilities are also not subject to the same inspection protocols as U.S., presenting a unique set of challenges. While inspectors have the right to show up to domestic facilities unannounced, the FDA often agrees in advance with plant management on an inspection date for overseas facilities, allowing time to cover up any deficiencies and to “stage” FDA appearances.

Peter Baker, a former FDA auditor attested to this in a new book on the generic drug boom, recounting how he discovered employees attempting to destroy or forge critical manufacturing records and uncovered fraud or deception in almost 80 percent of the overseas drug manufacturing plants that he inspected.

The New York Times recently asked the rhetorical question in an op-ed headline, “Americans Need Generic Drugs. But Can They Trust Them?” The opinion — by the women who wrote the book quoting Baker — addressed foreign inspections that exposed dangerous compromises behind the production of generic drugs and the “FDA’s limits as a global regulatory agency.”

As a former Congressional appropriator with responsibility for FDA oversight, I find it troubling that some overseas generic drug manufacturers are foisting tainted drug products, some with toxic impurities, on unsuspecting U.S. consumers. Given the fact Americans count on the FDA to be responsible for “protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices,” it is critical they have the tools to do their job.

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But despite the plethora of new FDA generic drug approvals over the last few years, Congress curiously cut the budget to inspect the facilities that will manufacture these drugs by 11 percent in fiscal year 2018. While it is right to call on the FDA to put the same effort into guaranteeing the safety of generic drugs manufactured overseas that they have put into processing new generic drug applications, Congress must make sure the agency has the money to make this possible.

The fact of the matter is generic drugs are used by millions of Americans each year, and consumers have every right to be assured that what is being ingested is pure and effective.

Generics drugs cannot skirt the rules by which our American manufacturers abide and by manufacturing overseas with unscrupulous foreign partners, gain a price advantage at the cost of safety. Striking this balance will allow manufacturers to proceed with confidence that they are fulfilling the mandate Congress and the Courts intended — to safeguard consumers from bad actors and lower generic drug costs.

Only then will Americans have the confidence necessary to consume foreign-made generics, knowing that they contain proper medication, are safely manufactured, and are effective for consumer use.

George Nethercutt is the former Republican Congressman from the 5th District of Washington; he served on the Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and related agencies.