Readers Write: My response to the FDA’s letter to me


Thought you’d all be interested in the FDA’s response to my questions on the quality of drugs manufactured overseas and my thoughts.

The FDA’s Center for Drug Evaluation and Research performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

Donald D. Ashley, director of CDER’s Office of Compliance, and Michael Kopcha, director of the Office of Pharmaceutical Quality, answered the questions I raised last week in my article on generic drugs and their quality.

Dr. Kopcha wrote that all drugs must consistently and safely provide their intended benefits. To do this, drug manufacturers must meet quality standards that ensure that every dose of a drug is of the appropriate strength and free of contamination and defects.

Their experts thoroughly assess a drug–and its manufacturing process–before approving it for the market to ensure manufacturers can meet quality standards. They audit the production line and require an evaluation of the manufacturing facilities prior to drug approval.

They regularly test products on the market in their state-of-the-art laboratories to confirm they meet quality standards, identifying possible problems so manufacturers can address them before they cause potential harm to patients.

They conduct regular inspections of drug manufacturing facilities to ensure compliance with our requirements, s with a particular focus on the facilities and drugs that have the potential to be the most problematic. Inspections to evaluate complaints and allegations made against a manufacturer are also conducted.

None of the tools above are sufficient on their own but when used collectively, we have high confidence in the quality of the U.S.drug supply.

Kopcha wrote that some regions of the globe do have somewhat higher levels of violations found during inspections but this is because facilities without a history of regular FDA inspections are likely to be less familiar with our requirements. Inspections are designed to prevent problems.

We conducted a major test on marketed products and bought 323 different drugs sold in the United States but made around the world–including more than 100 generics from India. All samples were tested and met the quality standards regardless of where they were made

Director Ashley mentioned that “we prioritize inspections based on the facilities and medicines that have the potential to be the most problematic”, and 80 to 90 percent of them–regardless of location– are substantially compliant with our requirements.

When we do identify manufacturing issues, we see similar issues in the United States and take “swift action to protect patients when we find problems that pose a significant risk to patient health.”

Some manufacturers are still working on improving their processes. We have been inspecting manufacturing facilities for many decades, but not all types of facilities have been inspected with the same frequency, particularly those making lower risk over the counter medicines.

Generic drugs are more likely to be made outside of the United States but it is common for companies to manufacture products for brand and generic drugs in the same facility. “Much of the U.S. drug supply originates beyond our borders, and yet the generic drugs on the market today are better than ever before.

Generic drugs are as safe and effective as their brand name counterparts and have the same quality of as brand name drugs.

Since the start of the Generic Drug User Fee Program in 2012, FDA has hired more than 1,000 additional agents to work specifically on generic drugs, conducting a more sophisticated and rigorous assessment of generic applications than ever before.

Ashley wrote that “we have several tools available when we suspect quality issues at a drug manufacturing facility. Often, they will conduct an inspection of the facility.

We even conducted unannounced inspections at manufacturing facilities in India and China. We can recommend the company, domestic or foreign, do take action to address potentially harmful medicine, such as recommending the company recall its medicine if it is already on the U.S. market or if it is a foreign manufacturer, to put them on import alert to block potentially unsafe medicines from entering the U.S. market.

We also seize medicines from warehouses or manufacturing facilities, issue warning letter to advise companies of their violations of the legal requirements and test imported medicines. We do not rely solely on inspections to uncover quality issues but also capture feedback from industry, healthcare professionals and consumers border to ensure the medicines are what they claim to be through reports submitted to Medwatch or the FDA Adverse Event Reporting System ”prevention is key Our goal is to identify possible problems so manufacturers can address them before they cause potential harm to patients.” With this in mind., the FDA has conducted trainings for industry in the United States, Europe, India, China and other parts of the world.

With these answers, I am comfortable with the quality of the generic drugs available to the U.S. consumer.


Great Neck


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