Between the FDA, mass tort attorneys, and drug manufacturers, there is a balance which swings now one way and now the other. There have been a number of highly-publicized drug recalls in recent years, and pressure put on the FDA to require stricter or longer testing of new drugs.

Drug companies already spend many years and billions of dollars on each new drug, first developing it, then testing it to get FDA approval. When the testing period is shorter, the drug can sooner start making money for the drug company, so it can start recouping its huge expenses. When the testing period is longer, the company must carry those expenses longer before they start to get any income from the new drug.

Approvals Delayed

Now it seems the balance is starting to swing torwards a longer FDA approval time. In the past year-and-a-half, Schering-Plough Corp has stopped development on two new drugs – one to combat obesity and one to lower cholesterol. They may also abandon a third drug. Fred Hassan, the Chief Executive, sees their odds for getting new drugs to the market as drastically lowered by a reduced FDA tolerance for drug side effects.

Similarly, Eli Lilly & Co. and the Japanese company Daiichi Sankyo, who have been working on a new heart drug, have said that the FDA wants an extra three months to decide whether to approve it. Merck has said the FDA wants to delay approval of their cholesterol drug Cordaptive until the end of a very large clinical trial, which would postpone any approval until 2013. Diabetes drugs are facing a possible new set of requirements related to their effectiveness on improving heart disease and lifespan, rather than just blood sugar levels.

Fewer Approvals and More Black Box Warnings

In 2007, the FDA approved only 19 new drugs, which is the lowest number in 24 years. It also required about 75 new or updated black box warnings about potential side effects, which is double the number required in 2004.

Complicating Factors

Each time a drug has a few adverse event reports sent to the FDA, the mass media jumps on it as a good source of bad news. Watchdog groups and politicians fan the flames and the end result is that to the general public, things look worse than they are. That a drug “could” cause a certain problem is not the same thing as that drug actually causing it. So politics interferes with science, and the FDA is caught in the middle.

In all this chaos, there are still instances where a drug does in fact cause severe side effects which perhaps were not warned about strongly enough in the drug’s paperwork and labeling. We have excellent experience in class action lawsuits. If you have been injured by a drug or medical device and wonder if you might have a reasonable legal claim, please feel free to contact our office for a free consultation.