Shocking Decision Risks Patients Lives Battling Cancer
WASHINGTON — Americans for Safe Drugs, a campaign led by the Coalition for a Prosperous America (CPA), released a statement after shocking reports that the U.S. Food and Drug Administration (FDA) is considering allowing temporary imports of two cancer drugs, cisplatin and carboplatin, from unapproved foreign manufacturers. The shortages of these two chemotherapy drugs was exacerbated after Intas Pharmaceuticals, an Indian drug manufacturing firm, shut down production after an FDA inspection found a “cascade of failure” where FDA investigators found piles of shredded documents.
“Additionally, we found a truck full of transparent plastic bags containing shredded documents and black plastic bags mostly containing documents torn randomly into pieces by hand mixed with other scrap materials,” the FDA stated in its report. FDA investigators also found additional documents inside a “large black plastic bag that was hid [sic] under the staircase.” After opening the bag, the investigators noticed “a very strong smell of chemical spread across the area,” and that the documents inside the trash bag were wet.
Dr. Karen Knudsen, CEO of the American Cancer Society, said the shortages highlight a long-standing economic problem in the generic drug market. “We need it to be financially viable for manufacturing to be able to produce effective, affordable cancer therapies … The fact that we’re sitting here right now talking about this cancer shortage tells us…there are not enough manufacturers to be able to overcome the supply chain issue,” she said.
“As a physician with over 42 years of practice, I would never give a patient a drug from an unapproved facility,” said Dr. Harry Lever, MD, one of the nation’s leading cardiologists. “We can’t risk patients' lives by giving them potentially bad drugs from unapproved manufacturers. It’s clear that Congress must act now to quickly increase production of lifesaving medicines in the U.S. Our country is in a national health care crisis and we can’t afford to be reliant on foreign manufacturers making bad drugs.”
Earlier this year, CPA published a report on how skyrocketing pharmaceutical imports to the U.S. are endangering national security. “U.S. pharmaceutical imports have skyrocketed in the last ten years, with imports from China, India and Mexico leading the surge,” the report stated. “India and China are increasingly the leading U.S. source for generic pharmaceuticals, which account for 90% of all prescriptions written in the U.S.” At least 14 cancer drugs are currently in short supply across the U.S.
“We know of two commonly used medications, Zantac and the blood pressure medicine Losartan, that have been found to have been contaminated with potential carcinogens,” said Dr. Marion Mass, MD, a pediatrician with two dozen years in practice and co-founder of the Practicing Physicians of America. “How many more don’t we know about? As a pediatrician it’s a huge concern for me. There are children who need medication’s daily. And, of course, children have many many more life years in front of them to develop possible long-term side effects from tainted ingredients in meds, now largely from China and India. Frankly, it’s chilling. Every parent in America should be calling up the FDA and telling them to make sure that their medication ingredients are safe.
In February, Americans for Safe Drugs released a statement after the FDA allowed Glenmark Pharmaceuticals, an Indian multinational pharmaceutical company, to export product to the U.S. market from its Baddi facility despite it being under an import ban after the FDA found significant violations of current good manufacturing practices at the facility.
“Once again, Americans are being thrown under the bus by the federal government's failure to shore up domestic manufacturing of medicines necessary to sustain life,” said Rosemary Gibson, author of China Rx. “It shocks the conscience that our government would do this to people fighting a brave battle with cancer.”
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.