Pro/Con: Is the FDA effectively monitoring prescription drug safety?
Yes: Watchful eye means US drugs generally safe There is a growing concern that American patients are unknowingly being given unsafe medicines from overseas.
The worry is so widespread that it has even led to public spats between scientists and physicians on one side and the U.S. Food and Drug Administration on the other. Yet with nearly 3 billion prescriptions filled every year in the United States, everyone agrees that the U.S. drug supply is generally safe.
Twenty-five years ago all medicines consumed in the United States were made here or in Europe and from U.S. or European ingredients. Today, 80 percent of the ingredients and 40 percent of the final products come from overseas, especially from China and India.
China has the cheapest chemical manufacturing in the world and India the cheapest final drug processing. Every pharmaceutical manufacturer, from the small companies no one has heard of, to the major U.S. brand names use ingredients from these countries.
There is however a significant difference between the brand-name products from an American company and the generic drugs from an Indian company. Here is why:
Given that all companies can make mistakes, and all companies risk having unethical workers within their midst, our trust in the products is based on how the companies respond to a problem and how the regulators who oversee them respond.
U.S. and European companies that have had problems in the United States and most recently in China and were found guilty by the courts have to deal with the strong response to their behavior.
As a result such producers are forced to maintain their high standards, regardless of where they source their products precisely because they know the consequences if they do not. Through education and decades of interactions between corporate staff and regulators, good practice has become inculcated into the systems of production.
That is not the case with many foreign companies selling into U.S., notably those from India.
For example, last year, the FDA fined the large Indian drug company Ranbaxy $500 million and found it guilty of seven felony counts related to data fabrication about the safety of Ranbaxy’s products over the prior decade.
Having won the sole right to make generic Lipitor for the U.S. market — arguably the most valuable drug in the world, at least by sales value — Ranbaxy is a billion-dollar player in the pharmaceutical world. But the problems with Ranbaxy did not mirror anything that would have happened with an American company.
First of all, the Indian government did not find out about Ranbaxy’s problems, the FDA did.
In short, U.S. pharmaceutical companies respond positively to evidence of wrongdoing, and the FDA closely monitors the manufacturers to ensure they do. Overseas, unsafe medicine production is often not punished as seen with India’s regulators. Commercial factors trump safety at every turn.
No drug manufacturer can ever say all their products are always safe. Yet with more and more sourcing from India and China, U.S. companies have to improve their supply chain controls, oversight systems and auditing procedures to ensure they are not fooled into buying suspect ingredients. But although the risk is not zero, because of all the oversight, one is safe buying U.S. manufactured products.
Roger Bate is an economist and health policy researcher at the American Enterprise Institute. Readers may write to him at AEI, 1150 17th St., Washington, D.C. 20036; website: aei.org.
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