Drugs are Getting Approved Faster by the FDA, but Does that Increase Potential Problems?
Miley Legal Group
According to studies published by the Journal of American Medical Association and SSRN, the pace of approving new drugs has been getting quicker. But is that a bad thing? Is the process becoming more efficient, or are the approvals being rushed, possibly leading to significant issues down the road? These are important questions that need answers.
A review of recent drug approvals has noted a few significant and potentially dangerous issues. One situation identified is that the drug approval rate is significantly higher during December. One study indicates that there is an 80% increase in approvals during the last month of the year. It could be assumed that it is because the agency feels the need to clean out their “inboxes” so to speak; unfortunately, the same study also suggests those drugs approved in December have a higher rate of adverse reactions.
In addition to the bump in approvals in December, studies also suggest that there has been a slow and gradual change in the approval process itself. More specifically, the studies note that most recent drug approvals have been done without multiple clinical trials. Approximately half of the recent approvals have been done with only one pivotal clinical trial.
But what does this all say for the dangers in drugs on the market today and in the future? We will not know the full impact of the changes in the way drugs are approved by the FDA until we see the results of use. Drugs in the market today go through testing to identify potential issues and side effects. If those same drugs are not as extensively reviewed or tested, what could be the potential impact on end-users? Will we see more unknown side effects? Will there be an increase in so-called “bad drugs” on the market? Will we see more huge lawsuits as a result of horrible, life-altering side effects?
There are too many questions to receive adequate answers, and when the topic is brought up to government officials, it appears there is little concern for the changes. Should there be a pause in the process and a review to ensure that citizens across West Virginia and the country are protected from greedy pharmaceutical companies that are rushing the process? (The process that the pharmaceutical companies pay for, as most FDA testing expenses, including employee salaries are paid for by the same companies that want to distribute million-dollar drugs.)
As a personal injury firm that deals with potential “bad drug” cases, it is crucial that we not only find ways for manufacturers to be responsible for ensuring the safe use of their products, but it is also important for us to point out weaknesses in the government systems put in place to protect consumers. Because when the government fails, travesty ensues; just look at the recent headlines about harmful products that are now found to cause shingles, cancer, and even death.
Sources: Biospace.com, JAMANetwork.com, and SSRN.com