Federal Code of Regulations (CFR)

All pharmaceutical companies follow a federal code of regulations when testing, manufacturing and promoting a drug product. These regulations are there to protect the consumer from abuse or poor manufacturing practices.  We often hear senators and pharmaceutical industry executives complain of extensive FDA red tape and documentation. Believe it or not, that is one of the few instances where it is a good thing. Could the process use some tweaking? Of course it can but I prefer to pay a little more from the cost of regulation and ensure that I am taking a well studied and safe drug product than play Russian roulette on my medication.

Throughout history, there have been cases in which a medicine produced a harmful or tragic consequence for patients instead of providing relief or curing them of their medical condition. The federal code of regulations came and was updated as a result of these tragic occurrences.

Medical Drug Effects History

In 1900, twelve children died in St. Louis, Missouri, after they were given injections of an anti-toxin to treat diphtheria. They died because the horse used as a source for the anti-toxin was later found to have tetanus. In the 1930’s sulfa drugs were the “miracle” products before penicillin. Elixir of Sulfanilamide, containing sulfa, was made by a firm in Tennessee. To improve the manufacturing process as well as the taste, a safe chemical solvent was changed to one that was poisonous: ethylene glycol. (Ethylene glycol is also found in antifreeze.) One hundred people, mainly infants and children, died after using the product.

This does not just happen in the United States, Each nation or group have nations have a regulatory agency similar to the FDA. For Example, European countries approved thalidomide in the early 1960s as a sedative. The product was very effective in helping people go to sleep. Pregnant women also found it very useful in reducing the nausea of “morning sickness”. Soon after, in Europe (where U.S. travelers purchased the product for their use) babies were born with short, truncated arms and legs. It was discovered that thalidomide was the cause of these birth defects. Thalidomide was being studied in the U.S. and was in the FDA’s drug approval process, but it was not approved because of questions related to its safety.

A small firm in Haiti was manufacturing a cold/flu medication containing acetaminophen that used the solvent glycerin. In 1995, a shipment of solvent was purchased and received from a distributor in the Netherlands. The firm used the material based only on a certificate of analysis and released the product to the local market. Within several months, the mysterious deaths of 88 children were traced back to the product. Extensive testing showed that the container labels and shipping documents did not match what was inside the drums- they contained propylene glycol and diethylene glycol (or anti-freeze). Investigations by regulatory authorities throughout the world traced the origin of the drums back to a chemical plant in China. The exact cause and source of the solvent is still unknown.

By having a global manufacturing process, now it is even more imperative to have regulations in place to ensure quality of pharmaceutical products and drugs. What is consumed in the US might not be manufactured in the US. The components are brought in from around the world and manufactured in one location before consumption. It is up to the FDA to monitor all aspects of production and testing around the world to ensure we have safe products for the population.

Do you think that pharmaceutical companies have you best interest at heart?