Can the FDA be fixed?
Once upon a time the Food and Drug Administration was highly regarded by physicians, pharmacists and the public. People trusted the agency to protect them from contaminated food and dangerous drugs.
Congress established the FDA in 1906 in reaction to public disgust about adulterated food and medicines. Snake oil salesmen roamed the countryside selling nostrums cooked up in bathtubs. There was no oversight or quality control.
The FDA went after abuses, and both food and medicine improved markedly. In the 20th century, many of the medicines we swallowed were actually made in America. FDA officials inspected pharmaceutical plants on a regular schedule to make sure good manufacturing practices were in use.
Today, the FDA is overwhelmed, understaffed and underfunded. It did not inspect the plant in Georgia that shipped tainted peanut butter around the country. Salmonella has been found in other food products from fresh chili peppers and alfalfa sprouts to children’s crispy snacks.
There are also problems with pharmaceuticals. Many of the prescription drugs and over-the-counter medications Americans swallow are made overseas. The FDA has great difficulty inspecting manufacturing plants in China, India, Indonesia and other countries where the chemicals for our medicines originate.
A year ago, an adulterated blood thinner (heparin) killed dozens of Americans. The backyard factories in China that produced the raw ingredient were probably no more sanitary than the snake oil salesmen’s stewpots of yesteryear.
There have also been numerous recalls of generic drugs. Despite frequent assurances that such copycat medications are identical to their brand name counterparts, scores of products have been recalled.
Last fall the FDA banned a huge Indian pharmaceutical company, Ranbaxy, from bringing 30 different generic drugs into the U.S. Nothing more specific than “manufacturing violations” was cited. Nevertheless, Ranbaxy’s generic versions of drugs such as the cholesterol lowering medicine simvastatin or the antibiotic ciprofloxacin were not allowed into the U.S.
More recently, a generic manufacturer called ETHEX, a division of KV Pharmaceutical, withdrew 60 generic drugs from the market. Among them were metoprolol succinate and nitroglycerin sublingual tablets. As a result, shortages of these important heart medicines have developed.
It will take time for the brand name companies to ramp up their manufacturing lines and supply these critical drugs in adequate quantities. Many patients who have been left in the lurch are wondering how this could have happened.
This might be just the tip of an iceberg. Hundreds of people have been complaining to their physicians and online (www.peoplespharmacy.com) that their generic drugs are not performing as expected. No one knows how big a problem this may be.
Contaminated heparin syringes were shipped around the country from a North Carolina plant for two years after the FDA was notified of problems. Hundreds were sickened and five died according to the Raleigh News & Observer.
It seems that FDA monitoring leaves a lot to be desired. With all the talk about reforming health care, perhaps Congress should take a close look at the FDA first.
