In theory, FDA fast-tracked drugs and devices make sense. The process encourages companies to develop helpful medical items and expedites the review process so that people in need can access better, more effective treatments. In an ideal world, fast-tracked drugs should eliminate side effects of other therapies while improving total health outcomes over time. Unfortunately, the program does not always work as designed.
Some FDA fast-tracked drugs and devices may be safe. Unfortunately, many issues with a “safe” treatment may not arise until a medication or device has been on the market for a few years. The expedited timeframes do not always give developers and researchers enough time to recognize serious side effects and damaging consequences. In fact, the process may encourage for-profit companies to move forward with projects that they know might cause problems.
Today, many attorneys are noticing a trend in dangerous drug and device cases. Many of the products that were fast-tracked prioritized speed before safety and put patients’ lives at serious risk. When certain blood thinning medicines cause uncontrollable bleeding events and have no known antidotes, people can die. When cancer treatments cause permanent hair loss and the manufacturer knew about the possibilities but failed to place a warning on the label, consumers may suffer long-term physical and emotional damage.
Since 1992, when the Prescription Drug User Fee Act was passed (including the legislation enabling the fast track program), the rate of new black-box warnings on drugs and recalls/withdrawals has increased. This increase highlights serious safety concerns.
Incentives for Speed
Pharmaceutical companies are not non-profits. They work to earn money, and some of them do not care about the long-term ramifications of their actions. All manufacturers are responsible for ensuring the reasonable safety of the products they produce. If they know about certain risks and dangers, they have a duty to inform the public through clear labeling and paperwork.
As part of the fast track and other programs, drugs and devices may not undergo the rigorous testing once required for FDA approval. In a study from 2008, clinical development for expedited drugs only took 5.1 years for approval compared to the 7.5 years of development for standard approval. As soon as a manufacturer earns approval, pharmaceutical representatives arrive at doctor’s offices. Patients and physicians put their trust in an FDA-approved label that may not be as safe as they hope.
Risk vs. Reward
Unfortunately, the problem is not as clear cut as simply slowing down the process. Speeding up the development timeline does provide some great benefits, particularly for patients facing serious prognoses. Some risks are worth the potential reward, and preventing patients from taking potentially life-saving medications or using a revolutionary device comes with its own set of ethical concerns.
Until regulations encourage stronger drug and medical device development processes, consumers must be vigilant. Medical products that have not been on the market for very long come with increased risks that your doctor may not know or fully understand. Carefully research drugs and devices before agreeing to use them, and ask questions if you have any reservations. For many medical products, there are alternatives that may represent a more manageable risk.
If you do suffer from a serious injury or side effect from using any drug or device, new or old, contact a West Virginia products liability lawyer at Tiano O’Dell, PLLC. Medical products are not “buyer beware” situations. You have the right to hold drug manufacturers and marketers responsible for failing to offer a safe product or warn you of the potential side effects.
At our firm, we are always available to answer your questions about drugs and medical devices that cause serious side effects. Some of the most commonly cited medications and devices causing problems today include Onlgyza, Pradaxa, Taxotere, Xarelto, transvaginal mesh, and IVC filters. Contact us today for a free case evaluation.