Home > Personal Injury Law Firm Blog | Witzer Law Blog > Legal News > Drugs, the FDA, and the Concerned Consumer
Drugs, the FDA, and the Concerned Consumer
The U.S. Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services that is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The agency is responsible for regulating $275 billion dollars in drug sales each year. In 2008, a WSJ.com and Harris Interactive Poll stated that, “Majorities of U.S. adults give negative ratings for the Food and Drug Administration (FDA) on a number of measures, such as ensuring new drugs come to market quickly (60% negative) and managing recalls or withdrawals when safety concerns arise (53%). The perception that the FDA does a good job ensuring the safety and efficacy of new prescription drugs (35% positive) has declined from 45 percent in 2007 and 56 percent in 2004, even though the general population considers this to be the most important task for the FDA to focus on (61%).” The poll concluded that only 26% of consumers think the FDA does a good job of ensuring the safety of drugs manufactured outside of the United States.
A large part of this issue is that every year doctors and pharmacists write approximately 65 million prescriptions for drugs not approved by the FDA, according to CNN.com. Many believe there is a huge “black hole” in the drug approval process where pharmaceutical companies distribute unapproved drugs into stores and the FDA is unable, or unwilling, to monitor them. Obviously with the speed of the American market system and the huge amount of products and services the FDA is tasked with regulating, it may be almost impossible for the agency to watch over pharmaceutical drug products in a way that is of an appropriate level for the interests of American citizens.
“I think most doctors, maybe all doctors, assume that if a medication is on the market, it has been approved by the FDA, it must be safe and effective.” American Medical Association President Ron Davis has stated. CNN.com concluded that pharmacists would appear to be no better informed about the status of their drugs. A recent survey showed more than nine out of 10 retail pharmacists didn’t know they could be dispensing drugs not yet approved by the FDA.
On the FDA.gov site, there are not any statistics about how many people have been killed or injured by unapproved drugs or even which unapproved drugs are the worst offenders. But with this “black hole” in regulation there are definitely unapproved drugs still on the market unbeknownst to doctors, pharmacists and consumers.
In the end, while it is unfair for a sick patient to have to perform due diligence by asking about a drug’s FDA approval and any potential warnings, the old adage is true, “the best consumer is an educated consumer.”
To learn about recent drug warnings and recalls visit our information on Raptiva and Reglan, or find out how the Law Firm of Brian D. Witzer approaches pharmaceutical litigation.
