The United States Food and Drug Administration (FDA) regulates medical devices and drugs. Just because a medical device or drug has been approved by the FDA, it’s not a guarantee of complete safety. In fact, this organization also documents potential adverse effects, potential drug interactions, recall information, and so on. They also classify some products according to potential risks.
Roles of the FDA
Besides approving, reviewing, and enforcing drug and medical device regulations, the FDA also enforces regulations for some other kinds of products. These other products include cosmetics, drugs for veterinary use, food, biological substances, tobacco, and products that emit radiation.
The FDA exists to protect the heath of the public. In the United States, many millions of people take prescription and over-the-counter drugs to preserve their health and relieve symptoms. According to the Kaiser Family Foundation, doctors, and other medical professionals wrote over four billion prescriptions in 2015. Because of concerns over safety, this organization recalls a handful of medications and medical devices each year.
The public should understand that medical devices and drugs may all have risks; thus, the FDA’s job is to understand and document these risks to make sure they are managed and minimized. Of course, all devices and medicines need approval from the FDA before they can be marketed within the country. To decide if these products meet legal standards, the FDA conducts a review of the effectiveness and safety. The organization conducts these reviews before they approve products. They also monitor these products after companies release them to the market.
FDA approval doesn’t always mean products have been tested as entirely safe or effective. Some companies gain approval just by proving that their new drug or device is very similar to products that have already been approved.
The FDA keeps monitoring products even after approval because they might cause unexpected problems when used by larger populations of people. In the event of a lawsuit or other negative reports about a product, the organization and the producer of the product cooperate in a product recall.
Controversies Over the FDA
The FDA has taken some criticism from the public. Some critics contend that this government body worries more about keeping drug companies satisfied than they worry about protecting consumers from dangerous medical. The way that the FDA gets funded has been one source of this criticism.
Before 1992, The Treasury Department funded FDA reviews. Perhaps reasonably, the medical industry pressured the government to get products reviewed and approved faster. This sparked a bill that allowed drug companies to pay fees for more rapid reviews.
In 1993, these privately paid fees only paid for about seven percent of review expenses. By 2009, they accounted for 60 percent. In 2014, the FDA’s budget would have private funding pay for 94 percent, or about $4.9 billion. Because almost all funding comes from the medical companies that hope to have their products approved, legal scholars, doctors, and the general public have raised suspicions.
For example, Dr. Sidney Wolfe, one founder of the Public Citizen’s Health Research Group, has criticized this practice. He says that the FDA has moved too quickly to approve some medicine because of this funding. According to the New York Times, Dr. Wolfe was one of the first people to raise concerns over Vioxx.
The Controversy Over Vioxx
Vioxx provides an example of one medicine that the FDA should not have approved so quickly. The anti-inflammatory medicine generated safety concerns after an association with a 500 percent higher risk of strokes and heart attacks. Merck, the drug’s producer, recalled this drug in 2004. Again, despite reviewer’s best interest, some unexpected results could occur when a drug gets used by millions of patients. That alone might not begin to generate lawsuits against a drug company or even against the government, but there is more to this story.
The FDA approved Vioxx in 1999. The next year, clinical trials suggest an increased risk of heart attacks after taking this medicine. The producer downplayed the dangers. Later, government investigations uncovered documents that revealed that people at Merck knew about these risks and still promoted this drug aggressively. Merck executives told their salesmen to avoid mentioning these clinical trials with physicians and stress the benefits of Vioxx.
The company ended up paying many settlements and judgments for their actions. For example, the Wall Street Journal reported that just the shareholder lawsuit ended up costing the company over $800 million.
Merck engaged in unethical behavior, but so did the FDA. An FDA researcher named Dr. David Graham accused his employer of subjecting him to harassment when he tried to publicize the studies that demonstrated this drug had been linked to several thousand heart attacks within the four years between 1999 and 2003. David Graham even produced emails that proved that his bosses attempted to get him to minimize the results of the study. He had been employed by the FDA for 20 years at this point.
The FDA’s Drug and Medical Device Approval Process
The process for approving medical devices and the process for approving drugs differs somewhat. In any case, the FDA usually begins by reviewing the results of clinical trials. These tests could be conducted in a lab or use tests on people or animals. Products don’t have to be free of risks. Benefits must outweigh risks. After products gain approval, companies also have to cooperate with the organization to comply with government regulations for manufacturing, marketing, labeling, and of course, monitoring.
Drug Approvals by the FDA
The Center for Drug Evaluation and Research (CDER) oversees the regulations for drugs. This division of the FDA usually takes between eight years and a decade to approve these products. However, some drugs have made it to market in less than half a year. In the past ten years, the CDER has approved hundreds of drugs. Most of these met the standard of similarity to existing drugs, but a few dozen were considered “novel” drugs, including 13 new cancer medicines and 13 medicines for rare health conditions.
Medical Device Approvals by the FDA
The division of the FDA that oversees medical devices is called the Center for Devices and Radiological Health (CDRH). The CDRH classifies medical devices as Class I, Class II, and Class III. Low-risk devices, like bandages, get assigned to Class I because they offer almost no risk to patients. Devices like syringes may fall into Class II because there are moderate risks associated with their use. Class III devices have the highest risks associated with their use. Examples could include medical devices like joint implants and pacemakers.
As with drugs, there have been some medical devices approved that did not meet the standard of having benefits that outweighed risks. DePuy ended up spending billions on lawyers and legal settlements after a joint implant called the ASR XL. This device failed sooner than expected and compromised the health of users because it shed metal properties while in use inside the user’s bodies.
Ongoing Regulation by the FDA
According to the Agency for Healthcare Research and Quality, over 700,000 people suffer from injuries or deaths every year because of adverse drug effects. As more people use drugs, the FDA gathers more information about negative drug interactions and other dangers.
As part of its ongoing regulatory duties, the FDA accepts reports about potential dangers from patients and medical professionals. The FDA investigates these reports and issues warnings to companies and health practitioners. The FDA has dedicated much of its website at FDA.gov to publishing information about recalls and warnings.
Recalls by the FDA
If the organization judges that a drug or device has an unacceptable failure rate, they may start a recall. Most manufacturers comply with these recalls. If they don’t, the organization may get their attorneys to force them to comply with legal action. In most cases, the FDA only oversees a recall. The main responsibility for recalling products falls upon the product’s manufacturer.