The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

After hearing tearful testimony this week of the family
members who recently lost loved ones treated with contaminated batches of the
popular blood-thinner Heparin. Heparin was recalled in February when it was
discovered that some batches of the product had become contaminated. The
contamination was traced back to a Chinese plant that produces the raw
ingredients for the American manufacturer Baxter International. The FDA had
never inspected the plant. The FDA now believed that the contamination was most likley intentional, in effort to cut costs and improve profits. It is apparent
that more inspections are need to ensure the safety of foreign manufacturing
plants, but the under funded agency has simply does not have the estimated $250
million it would take to perform the inspections.


One proposal would require drugmakers to pay fees to the
U.S. Food and Drug Administration to boost capacity to check overseas
manufacturing sites in an effort to keep counterfeit or contaminated drugs from
reaching the U.S. market.


While this seems like a good option at face value, some
lawmakers were concerned with the intricacies of the proposal, and called for
better explanation of exact how the fee would be used.


Over 80 percent of active drug ingredients are produced
abroad. With the recent recalls of Chinese toys for lead paint violations and
contaminated pet foods, the recall of Heparin should be cause for some concern.
The contaminated Heparin has already been linked to 81 deaths, and something
must be done to ensure that this does not happen again in the future.

Comments are closed.

Of Interest