Generic Drugs- Small Government and Less Regulation Lead to Lack of a Safety Net in Production

Years ago under pressure from consumer groups, Congress dramatically reduced the time a drug manufacturer could retain a patent on a brand drug.  The patent was reduced from 21 years from release of the product after FDA approval to 7 years from the time development begins. The extremely short window of opportunity to research and develop new medications led to extraordinarily high prices for the new medications. The law met its intended result of encouraging the rise of copy cat less expensive generic drugs.

At the same time under the Reagan Administration, the Food and Drug Administration closed its research and evaluation labs for testing new pharmaceutical products before they can be released to the American public. Under the new laws, pharmaceutical manufacturers now can contract with outside labs to test their products and the reports are then submitted to the FDA for review and approval.  No longer did a drug company have to submit its actual product to the FDA for their independent testing and approval or denial.

The results of these two pieces of government de-regulation was the rise of generic pharmaceutical manufacturing plants in remote regions of China , India and Asia with the most reliable and technologically advanced plants in Israel. Generics needed to prove to the FDA that they possessed 85% of the bioavailability of the brand product in reports generated by contracted labs and sent to the FDA for the products approval.

For years I suggested to my patients that if they could afford the brand name they were best served paying the higher price to obtain a product they knew was produced locally with relatively high standards.  The NY Times on Saturday August 13, 2011 ran a front page article noting that over 80% of generic products are produced in “shadowy” foreign factories that have never ever been inspected.  Several years ago 81 individuals perished because Chinese manufacturers substituted cheaper and tainted products in the making of the anti coagulant heparin. Counterfeit packaging and products originating with the Russian mob proliferate throughout the world market and are difficult for experts to distinguish from the real thing.

It appears that the Obama administration has finally reached an agreement with the generic drug industry for the industry to pay for government inspection of their facilities every few years. The legislation may pass through Congress this fall.

My suggestion to my patients remains the same. If you can afford the brand product purchase it. Know where your pills come from. Demand that your Congressional elected official works to fund the FDA so it can reopen its research and evaluation lab and be the independent agent determining the safety and efficacy of the drugs we are prescribed. Consider extending the length of a patent on new products in exchange for lower pricing on brand name drugs. It’s time to stop allowing only market forces to be watching out for the safety of our medications. That’s like asking the fox to watch the hen house.