WASHINGTON (7News) — For two years, we’ve investigated the safety of America’s generic drug supply - interviewing whistleblowers, scientists, former FDA inspectors and patients who say the system is failing.

Now, instead of backing away from its position, the FDA is doubling down.

Approximately 90-percent of prescription drugs used in America are generic. Just less than 50% come from Indian manufacturing facilities. Photo: Spencer Platt/Getty Images

In a series of newly published web pages, the agency again insists generic drugs meet the same quality and safety standards as brand-name medicines - even as Congress prepares legislation built around the idea that that is simply not true.

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At the center of a new bipartisan bill from Representatives Rich McCormick and Rosa DeLauro is a mandate requiring the Department of Defense to only purchase drugs for the military that are independently identified as low risk from manufacturing mistakes and contaminants.

I’ve said this forever – the FDA is slow to deal with these issues,” said DeLauro. “They should not be. Oftentimes I just wonder if they really want to regulate, but that is their function and their job.

The legislation builds on a pilot program launched by Congress that has already exposed serious problems, from cancer-causing contaminants to improperly made medicines, many of which are made overseas in India.

The premise is simple: Instead of assuming every generic drug is equally safe, identify drug quality from worst to best and reward those at the top with federal purchasing contracts, starting with the U.S. military.

Rep. Rosa DeLauro (D-CT), who is championing bipartisan legislation to reform how the military sources medicine. The bill would require the Department of Defense to prioritize independent drug quality and safety testing over buying from the cheapest bidder.

“We want to make sure that whatever purchase there is in a generic drug that they're taking is not going to put them in harm's way,” said DeLauro.

In a recently published response that appears to directly address growing criticism of the agency’s oversight, the FDA insists that “generic drugs must meet the same rigorous quality standards as brand drugs in dosage form, safety, strength, quality and performance characteristics.”

We sat down with Dr. Arthur Kellermann, a longtime emergency physician, former CEO of VCU Health System, and co-author of a landmark New England Journal of Medicine article on the failing generic drug system.

Fletcher: “The FDA has now doubled down publicly telling Americans that generic drugs meet the same quality standards. Is that scientifically supportable?”

Kellermann: “No, not at all.”

Fletcher: “If the FDA cannot independently verify the quality and safety of generic drugs, should it continue to tell the American public that all generic drugs are equal to brands?”

Kellermann: “Absolutely not. We have to test products. And the FDA continues to this day to rely on factory inspections even when they admit to Congress that they may be five or six or seven years between visits. They continue to rely on paperwork submitted to them from the other side of the world without any way of independently validating that what's on those papers is correct. That's not good enough.”

The FDA’s website suggests that the criticisms are simply “anecdotes and public concerns” that “omit important context” about the agency’s oversight.

Anecdotes? I was appalled," said Kellermann. "I really was. I just thought that was more than disingenuous. That was offensive. Again, you're looking at congressional committees, investigative journalists, scientists, patients.

Challenging the FDA: Dr. Arthur Kellermann co-authored a recent NEJM piece arguing that mounting scientific evidence contradicts the agency's blanket stance on generic drug equivalence. Photo: SBG

What the agency may dismiss as anecdotes, others see as a systemic failure of transparency. Congresswoman DeLauro argues that when it comes to the health and safety of Americans, the facts shouldn’t be a secret.

Americans need to know what's in their drugs, what's in their food, what the prescriptions on their labels are,” said DeLauro. “They need to know what is there, absolutely. It is the right to know.

We asked the head of the FDA’s Office of Generic Drugs, Dr. Iilun C. Murphy, who authored that webpage, to explain why she seemed to dismiss the evidence from independent scientists, congressional investigators, outside labs and even the FDA’s own inspectors.

She declined our interview and told us to submit questions in writing, which we did. The agency told us they needed additional time, beyond the deadline of this story, to answer our questions. You'll find those answers here, if we receive them.

If you or someone you know has had medical consequences from foreign-made prescription or over-the-counter medications, we'd like to hear from you. Lisa can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it. and Andrea at This email address is being protected from spambots. You need JavaScript enabled to view it..