safety concerns

The Food and Drug Administration is caught between two hard rocks. On the one hand the agency has been criticized for inadequate oversight of foreign drug manufacturing facilities, especially in China and India. On the other hand, the FDA has been hammered for allowing drug shortages to persist, especially when many of the drugs are essential for the public health.

The Latest FDA Boondoggle:

According to the industry insider newsletter, FiercePharma, the FDA is ignoring its own cautions. The agency  will allow importation of pharmaceutical ingredients from Chinese and Indian manufacturing plants that have been found to have problems:

“To avoid shortages, FDA allows imports from 8 drug plants banned for quality shortfalls.”

“Banned Hisun plant in China gets exemptions on 15 ingredients.”

“Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant” (Bloomberg)

Chinese Drug Imports from Problem Plants:

In the last few years the FDA has increased the number of inspectors it has on the ground in India and China. It hasn’t been easy. FDA inspectors have had a hard time getting visas to enter China. Unlike the unannounced inspections that occur in the U.S., the FDA must alert officials in China and India that they are coming well in advance of a visit.

Even with such obstacles, the inspectors have found troubling lapses in quality. The more inspections, the greater the number of problems that have been uncovered. There has been out-and-out fraud, where companies have been found to fabricate data. In other cases there has been poor quality in manufacturing.

In the case of one of China’s major drug exporters, Hisun, the FDA revealed that there had been “broad data manipulation” at its factory in Taizhou. Despite an FDA ban on exports from the factory to the U.S., the agency has apparently allowed the pharmaceutical company to continue exporting various key ingredients to the United States. That’s because those ingredients are considered essential to treat patients with leukemia, breast and ovarian cancer. Antibiotics and heart medicine have also been exempted from the ban.

This would be a little like a elevator inspector saying that there were such significant problems with an elevator that it should not be permitted to carry passengers. Then, in the next breath the inspector allows the elevator to stay in service  because it would be difficult for people to reach their floor without the elevator. Would you feel comfortable riding in such an elevator?

FDA Does Little to No Testing:

You might imagine that if the Food and Drug Administration banned a pharmaceutical company in India or China from exporting its products to the U.S. and then overturned its own ruling, the agency might test those products for quality. Au contraire. The FDA does virtually no testing itself. It relies on the companies to do their own testing or hire outside companies to audit their products. To us that seems a bit like asking the foxes to guard the henhouses.

Why Would We Accept the Honor System for Foreign Drug Manufacturers?

We are not the first to suggest that the FDA relies on the honor system when it comes to drugs manufactured abroad. Companies are allowed to submit test results that the agency does not check. We would prefer Ronald Reagan’s approach: “Trust but verify.”

People with cancer deserve to know where their chemotherapy drugs are coming from and be assured that the FDA is guaranteeing absolute quality. Although the agency continues to reassure the American public that everything is fine with Indian and Chinese drug imports, we would like to know why there have been bans on the one hand and exemptions on the other.

What do you think? Share your own thoughts in the comment section below.

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  1. Michael
    Wolfeboro New Hampshire

    So let me get this straight. Congress passes Part D, not allowing Medicare to negotiate drug prices. Drug prices rocket up so Americans start getting drugs from Canada. Congress makes reimportation of American-made drugs illegal, citing safety concerns. Now they allow importation of drugs made with no oversight, and obviously dangerous to the public, from India and China. Lobbying Congress apparently works.
    Profits always come before people in America.

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