An opinion piece in the Washington Post “Generics are cheap and popular, but some might not be as safe as you’d expect” was written by C. Michael White, a professor and head of the Department of Pharmacy Practice at the University of Connecticut. In it, he warns of the number of drugs manufactured overseas, contamination risks, and the lack of direct FDA oversight.
The article is based on an editorial he wrote for Annals of Pharmacotherapy This is a critically important issue, and one for our legislators to examine.
Generic medications become available when the patent runs out on a particular drug. Drug companies sometimes pay the generic manufacturers to delay releasing a generic (less expensive) version of the drug. If the generic manufacturers can make more money by withholding a drug from the market, it makes good business sense. However, maintaining drug prices artificially high hurts everyone.
Most providers allow generic substitutions when they are available and many states require it. About 90% of prescriptions today are available in generic form. Generics cost less, and up to now, were thought to be equivalent to their more-expensive brand name counterparts. Katherine Eban, author of Bottle of Lies spent TEN years investigating the overseas generic manufacturing business and the lack of true FDA oversight. She expresses serious concerns about drugs coming from other countries. The FDA publishes warning letters sent to manufacturers who violate standards for producing these drugs. A private Web site collates these letters and indexes them for easy searching and analysis
Never forget the expert on your health is YOU! If you are taking a generic drug and not getting the results you expect, do some detective work. First, alert your provider that you are concerned about the quality of the generic drug because you are not getting the expected benefit. Next, check with the pharmacy to find out the manufacturer of that particular generic drug. Then, you can look up the company on the FDA Web site to see if there have been warning letters issued. Finally, discuss your concerns with your provider to come up with a plan; the provider’s discussion with the insurance company may allow you to get the brand name drug for safety. If not, you can always appeal with advice from the Connecticut Healthcare Advocate.