FDA Fast Track: Is Pay-for-review Too Fast?
Following a topic I mentioned in the last post, I’d like to review the increasingly visible issue where approved drugs in the pharmaceutical market have come under greater scrutiny because of serious side effects of these medications. The trend seemed to start around the time Merck’s anti-inflammatory drug Vioxx was targeted because of its link to increased risk of cardiovascular events. Competing products, specifically Pfizer’s Celebrex and Bextra were also liked to an increased risk, though from my understanding the risk varied depending on the dosage of the drug.
More recently, Novartis has come under the same scrutiny over Zelnorm, and 3 anti-anemia drugs from Amgen have been put under the microscope, all because of possible links to increased heart attacks and stroke.
So what does this mean? Most drug companies spend billions of dollars to research, develop and market a drug. Pharmaceutical companies like Pfizer or Merck depend on the success of these drugs in order to grow revenues and replace drugs that have patents with little life remaining. Lipitor, for example, is a $10 billion a year drug, so not only was it worth its initial investment to develop, but it would behoove Pfizer to find another blockbuster drug that can plug the vast hole Lipitor will leave once its patent has expired.
In 1992 the FDA implemented the Pharmaceutical Drug User Fee Act a program that shortens the length of time to approve drugs for sale in the United States. Previous to 1992, the administration was flooded with requests and would often take up to 33 months to fully review and approve a product. With the advent of the Pay-for-Review program, a drug company was given the option to pay a fee to expedite the approval process. The funds collected from this program were used by the FDA to pay for the additional staff and resources needed in order to deliver on their promise. At this time, the process has been shortened from 33 to 12 months, and has been considered by many to be a great success.
But what of the consequences? There is an excellent audio report by Joanne Silberner of NPR’s “All Things Considered”, run on May 3, 2007, that considers the implications of the program and its current status. You can listen to a copy of it here, on NPR’s web site. In it, Silberner highlights the history of the program and positive advances that have been made as a result of this change, but one critic in the report also indicates that drugs approved in this fast track have shown more safety issues than those that follow the standard approval process.
This, of course, raises the question: Are these fees causing the FDA to become puppets of the very industry they’re trying to regulate? Or do you see this change resulting in more, better drugs entering the circulation of the American drug market? Should drugs like Vioxx, Celebrex and Zelnorm continue to be approved on this fast track in order to provide relief to millions at the risk of serious side effects to a few? Moral and ethical questions are too numerous to ponder…I’d love to hear what you think about it.
