Americans for Safe Drugs
Zydus Pharmaceuticals Of India Continues Its Five Year Trend Of Failed FDA Inspections
The FDA continues to allow products from these labs to be sold in the U.S. because it is often more concerned with supply than safety.
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WARNING: Your generic medication may not be safe.
Fighting Against Unsafe Drugs and Unfair Foreign Competition
Americans for Safe Drugs is 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. We want every American to be able to trust the generics they take—every pill, every vial, every time.
FDA Warning Letters
Chinese and Indian manufacturers receive the most Warning Letters from the FDA for violating safety regulations and quality control measures. Yet they are still allowed to export generic medicines to the U.S.
Unsafe, Substandard Drugs
Foreign facilities in China and India have received Warning Letters for violating FDA’s safety regulations, including for violations like hair in a vial, carcinogens in medicines, and manufacturing processes that are not sterile.
FDA Inspections
The FDA hasn’t inspected the majority of foreign manufacturers in China and India that are under Warning Letter since 2019. Incredibly, they have suggested doing virtual inspections of these sites.
Price gouging & Supply Chain Shortage
Foreign manufacturers in China and India undercut U.S. producers to drive them out of the market and monopolize the industry. Then they raise prices dramatically—up to 2000%—gouging American patients.
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Latest News
Do you trust generic medicines from foreign manufacturers that have violated FDA’s safety regulations?
Currently, the FDA allows generic medicines to be imported from foreign manufacturers in China and India that are under Warning Letter due to violations of FDA’s regulations. This jeopardizes the safety of millions of Americans patients and allows foreign manufacturers to violate the safety standards and quality control measures that are required of U.S. domestic manufacturers.
These Foreign Drugs Aren't Safe
DID YOU KNOW?
73% of physicians say their trust in the global supply chain's ability to supply safe, quality medications has been eroded.
*The nationwide survey included 500 board-certified U.S. physicians who work at or are affiliated with a hospital system or spend some portion of their time working in a hospital setting. The survey was conducted on behalf of USP by Ipsos in September 2021.
Katherine Eban
Bottle of Lies: The Inside Story of the
Generic Drug Boom
Indian executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators… Ranbaxy had not properly tested the stability of almost any drugs on the U.S. market. The most basic good manufacturing practices require continuous monitoring of drug quality.
We are not liable for consumer protection. If we were liable, the product would be very, very expensive. If you want a cheap product, the price is that we do not take any liability for consequential damages.
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