Recent articles have prompted questions about the quality of the nation's drug supply. Michael Kopcha, PhD, a registered pharmacist and the director of the Office of Pharmaceutical Quality at the FDA, answers some questions about drug quality.
How does the FDA assure the quality of drugs in the U.S.?
Kopcha: All drugs must consistently and safely provide their intended benefit. To do this, drug manufacturers must meet quality standards that ensure every dose of a drug is of the appropriate strength and free of contamination and defects. The FDA assesses a drug -- and its manufacturing process -- before approving it.
Surveillance programs continue after a drug is on the market so we can check that manufacturers correct any problems as soon as possible. The FDA also conducts inspections of drug manufacturing facilities to ensure compliance with our requirements. We prioritize these inspections based on facilities and drugs that pose the greatest potential risk to patients.
Are drugs legally marketed in the U.S. but made outside of the U.S. of lower quality than drugs made domestically?
Kopcha: There is no difference in the quality of drugs legally marketed in the U.S. based only on their origin. The FDA has the same quality standards and conducts the same inspections of manufacturing facilities around the globe. We also did a test. We bought 323 different drugs legally marketed in the U.S. but made around the world -- including more than 100 from India. All samples met the tested quality standards regardless of the drug's origin.
Are generic drugs of lower quality than brand-name drugs?
Kopcha:Generic drugs have the same risks, benefits, and quality as brand-name drugs. They use the same active ingredients and work the same way. Generic drugs go through a rigorous assessment prior to receiving FDA approval. We conduct inspections of generic drug manufacturing facilities to ensure compliance with good manufacturing practices. The FDA monitors brand-name and generic drugs to make sure manufacturers produce safe, effective, quality medicines for patients.
By the Numbers
252: Number of drug manufacturing facility inspections in India in 2018, an all-time high.
Around 80%: Percentage of manufacturing facilities for active ingredients in drug products outside the U.S.
Around 80%: Percentage of respondents to a WebMD.com survey who felt generic drugs were of equal quality to the prescription brand-name version.
Around 80%: How much lower the cost of a generic drug is, on average, compared to a brand-name drug.
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