It’s a serious question all of us should be asking ourselves. Does the governmental agency’s approval of a drug or medical device whose mission is to protect the safety and welfare of consumers mean anything? Does it mean the drug or device is safe to use and will work the way in which the manufacturer says it will in its marketing promotions? Recent history offers us a cautionary tale. Many of the drugs and devices that are approved by the FDA have become the subject of market withdrawals, recalls, and safety warnings after innocent, unsuspecting consumers are injured by them. Each year, 1 in 20 persons die from side effects of FDA approved drugs. These are the facts that relate the sad state of affairs in government regulation of the pharmaceutical and medical device industry.
Why is this so? The FDA has become politicized and subject to the allurements and big money from lobbyists and so-called researchers who have a financial stake in the approval of the drug or device.
According to Diana Zuckerman, president of the National Center for Health Research, the “FDA approval is based on evidence — provided by the company that makes the medical product — that the benefits of the product outweigh the risks for most patients for a specific use. It doesn’t necessarily mean the product is safe.”
The key phrases in Zuckerman’s statement concern the evidence provided the FDA. The medical companies put forth the best (not necessarily all) evidence to get their drug or device approved. This slants the decision in favor of approval.
The amount a drug company spends to get a new drug on the market is a constant source of debate. Industry claims it is in the billions. It frequently uses this number to justify charging Americans higher drug prices. In 2011, Donald W. Light and Rebecca Warburton challenged that figure.
Light is a professor of comparative health care policy at the University of Medicine and Dentistry of New Jersey and a founding fellow of the Center for Bioethics at the University of Pennsylvania, and Warburton is a professor of health economics at the University of Victoria in Canada.
According to Light and Warburton, $56 million is the net cost to companies after taxpayers cover 50 percent of research and development expenses for each new drug they develop. They say drug companies get a large portion of costs paid back from writeoffs, National Institutes of Health grants and other forms of creative accounting.
In addition to controversy over the financial cost of drug and device approval, there is the larger issue of the pace in which these products are approved by the FDA. Fast tracking drugs and devices are pushed aggressively by manufacturers, arguing that the quicker these products get to the market, the more benefit they are able to accomplish. Safety advocates argue that fast tracking procedures lead to serious errors. While fast-track programs may compromise safety, the FDA’s regular approval process is also not without its own issues. For instance, clinical trials the agency uses to determine safety and efficacy also have several limitations, according to Consumer Reports.
According to a 2003 survey quoted by Consumer Reports, FDA reviewers felt rushed and pressured to approve medications. There are also some studies that found the faster a drug was reviewed, the greater the chance for adverse events surfacing after the drug hits the market.
If that’s not serious enough, another issue of concern relates to the FDA’s relationship with the pharmaceutical industry. While taxpayers still provide about one third of the FDA’s funding, the agency receives the majority of its drug-review funding from Big Pharma — the very industry it should be regulating. It’s a little-known fact to most Americans, and it raises red flags for a number of consumer groups.
Michael Carome, Director of the Public Citizens Health Research Group noted, “User fees fundamentally changed the relationship between the FDA and the pharmaceutical industry such that the agency now views industry as a partner and a client, rather than a regulated entity.”
The fact that Big Pharma pays a substantial amount of FDA’s operating costs should give anyone pause, according to critics. This is a big conflict of interest.
Is there value in the FDA? That’s an open question leading the buyer to beware. The myriad conflicts and issues surrounding the agency should lead our elected officials to reform or overhaul the entire drug and device approval process. That would be a step in the right direction concerning healthcare reform.
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