If you've been reading the news lately, you may have come across some talk of the Food and Drug Administration's latest approval. Vectibix is a drug used to treat colorectal cancer, the third leading cause of death in the United States. The drug has been shown to slow tumor growth and, in some cases, reduce the size of tumors. According to the FDA, 55,000 deaths will occur from colon and rectal cancer in 2006.
After years of safety and efficacy testing had already been completed, biotech company Amgen, the maker of Vectibix, began submitting data in December and completed its FDA approval application in March. The agency reviewed Vectibix under an accelerated program for life- saving drugs. It is now September, and the drug has just been approved. Including all the time the drug company spent jumping through the FDA's regulatory hoops, it took the FDA nine months to approve the drug.
This raises an important question: If a drug has the potential to save thousands of lives each year, and the FDA takes nearly a year to do nothing but review the paperwork, how many people died while the FDA was busy flipping through paperwork? It doesn't take a mathematician to come up with the answer: a lot.
Clearly this problem is more pronounced with life-saving drugs. If a person is given three months to live, they will probably be willing to take a drug that may have adverse side effects. The worst the drug can do is kill them, but their death is already imminent. However, this problem also exists with other drugs. Why should a person have to deal with chronic arthritis pain just because the FDA is being overly cautious on approving a new painkiller? Even when adverse side effects of a drug have been found, why should the FDA be able to decide whether the benefits outweigh the costs? Shouldn't individuals be able to make those decisions for themselves?
While a moderate solution might be to encourage the FDA to review drugs more quickly, this has already been tried. The rapid-approval status for life saving drugs such as Vectibix was the FDA's attempt to do just that. As we have seen, the FDA's idea of fast approval is just under a year. While there is no perfect way to guarantee consumer safety, this system is simply too imperfect. The FDA is meant to save lives, but by erring on the side of caution it can perversely cause more deaths with its inefficient approval process than the free market would cause without its help.
Before throwing this paper down in disgust at my na've trust in markets, take a minute to think about how market mechanisms work and how this would apply to the pharmaceutical industry. A company that sold a drug that killed people would not make a profit. Not only would they not profit, they would likely be taken to court and go bankrupt. Clearly, there is an automatic incentive to produce only safe products. Companies are going to be very careful to release only safe drugs to the general pubic. While this incentive will undoubtedly not keep all harmful drugs off the market, neither does the FDA. Furthermore, without the FDA's long and expensive approval process, drugs will be less expensive for consumers.
Many consumers will probably be more willing to trust only drugs whose safety had been verified by a third party, much like the assurance now provided by the FDA. Already, though, private bodies certify the safety of everything from medical devices to automobiles to electrical appliances. It's easy to imagine how such a process could be developed by one or more competing companies to supply the demand for drug safety evaluation. If consumers are willing to pay more for their drugs for this extra protection, then drug companies will be happy to pay for a stamp of approval in order to increase sales. But, most importantly, the competition between efficiency and safety needs would allow drugs to reach the market more quickly while also providing the level of safety consumers demand.
More importantly, people who are dying or in intense discomfort and willing to take unapproved drugs - and assume the risks - will be able to do so. Under free market solutions to pharmaceutical safety, consumers who are in dire need of decision-making power will be able to take their lives into their own hands instead of waiting for the FDA to approve a life saving drug.
What the dismantling of the FDA would really boil down to is an increase in consumer choices, and consumer demand for certification is likely to result in little or no real difference in the safety of drugs. Chances are great that fewer people will die unnecessarily as a result of mistakes from pharmaceutical companies than are dying today as a result of government overregulation.
Erin Wildermuth is a senior in the School of International Service and a libertarian columnist for The Eagle.
