FDA Labeling: Friend or Foe?
The application for FDA approval is usually about 100,000 pages long. According to the FDA, the label is required to provide necessary information about a particular drug. This includes how the drug is effective, potential risks, and how to use it. However, FDA officials recently suggested that certain diabetes medications, should be pulled off market shelves due to concerns that it could cause heart attacks. When similar incidents like this one occur, one cannot help but ask, “Just how effective is the FDA’s approval process, anyway?”
One of the primary reasons cited for the high cost of prescription drugs is the FDA’s lengthy and costly approval process. But how effective can this process be, considering it takes an average 12 years and hundreds of millions of dollars for a new prescription drug to travel from the laboratory to market shelves? In addition, how is important information about a drug missed until after it has already entered the market?
What about drugs like Colchicine? The FDA did not approve Colchicine because it predated the FDA approval process; it existed like thousands of other drugs on the market, as a generic drug that is much more affordable than brand-name drugs. In Colchicine’s case, its branded counterpart costs nearly 50 times more per pill. This is because URL Pharma (the drug company) convinced FDA officials that the brand name version of Colchicine is safer, in spite of the fact that many physicians have disputed URL Pharma’s claims.
It is a shame that the FDA is allowing URL Pharma to charge an outlandish amount for a medication that was already available at a fraction of the price. Furthermore, it will probably force the long-used generic brand off the market under the pretense that the generic brand is less safe due to its label. The FDA found that the brand name drug’s regimen for recommended dosing and its interaction label make it safer than the Colchicine generic alternative.
Monheit is the managing lawyer at Monheit Law, outside Philadelphia, Pennsylvania. He has practiced law since 1989. Michael Monheit was the managing attorney of the law offices of Herbert Monheit — now Silverman and Fodera — a firm founded by... Michael Monheit→
