Read the attached news article, which raises concerns about FDA investigation of generic drug manufacturers: New York Times: Katherine Eban, Americans Need Generic Drugs. But Can They Trust Them?
Write 3-5 sentences discussing any of the following questions, as well as 3-5 sentences responding to another student’s comments: (1) What problems do you see with the FDA’s current regulatory process with respect to generic drugs? (2) How should these problems be addressed? How could investigation and enforcement be improved? What types of interventions do you think would be most effective?11/2/21, 8:12 AM Opinion | Americans Need Generic Drugs. But Can They Trust Them? – The New York Times
Americans Need Generic Drugs. But Can They Trust Them?
The fake quality-control data, bird infestations and toxic impurities at the overseas plants that could be making your medication.
May 11, 2019
By Katherine Eban
Ms. Eban is the author of the forthcoming “Bottle of Lies: The Inside Story of the Generic Drug Boom.”
In the fall of 2012, a young consumer safety officer at the Food and Drug Administration volunteered for a job that few of his colleagues
wanted: inspecting the Indian manufacturing plants that make many of America’s low-cost generic drugs.
In a world of drab auditors, Peter Baker stood apart. He rode a motorcycle and had tattoos lining one arm. Beyond his love of adventure,
Mr. Baker, then 32, had a more pragmatic reason to volunteer. By reputation, India was the world leader in aseptic manufacturing, the
exacting science of producing sterile drugs. He figured that after reviewing best practices there, he’d return to the United States with
expert knowledge that would advance his career.
America needs generic drugs. They make up 90 percent of the American drug supply. Without them, every large-scale government health
program — the Affordable Care Act, Medicare Part D, the Veterans Health Administration, charitable programs for the developing world
— would be unaffordable.
But what Mr. Baker uncovered in six years of doing foreign inspections exposed the dangerous compromises behind the production of
generic drugs, and the F.D.A.’s limits as a global regulatory agency.
Six months into his stint, Mr. Baker visited a plant in Aurangabad run by the Indian company Wockhardt, which made about 110 generic-
drug products for the American market. He had one week at the plant to ensure that it complied with the F.D.A. regulations known as
“current good manufacturing practices.” Generating and preserving data at each manufacturing step is crucial to those regulations.
On his second day at the Wockhardt plant, Mr. Baker and a colleague caught an employee trying to smuggle out a garbage bag of
documents. The documents led Mr. Baker to discover that the plant had knowingly released into Indian and other foreign markets vials of
insulin containing metallic fragments. These had apparently come from a defective sterilizing machine. He learned that the company had
been using the same defective equipment to make a sterile injectable cardiac drug for the American market. The willful deception there
and at other plants so shocked him that he overhauled his inspection methods, with significant results.
Two months after Mr. Baker’s Wockhardt inspection, the F.D.A. banned the import of drugs from that plant into the United States, a
potential $100 million loss in sales for the company. Comp
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