FDA Approval Process for New and Generic Drugs Called into Question

With drug manufacturing companies introducing new and generic medications to the market on what seems like a daily basis, and with growing concerns about the potentially dangerous side effects of pharmaceutical drugs, it is more important than ever for the U.S. Food and Drug Administration (FDA) to ensure that new drugs are adequately tested and researched before they are permitted to enter the market. However, the findings of a new study suggest that the FDA is using less data and requiring much shorter review periods for new and generic medications, which has resulted in the approval of less meticulously researched treatments.

FDA Expediting New Drug Approvals

In a study published this month in the Journal of the American Medical Association, researchers from the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School in Boston, Massachusetts posed the question “How has the regulation of prescription drugs evolved from the 1980s to 2018, and what trends have occurred in drug approvals?” According to their findings, approvals of new and generic medications have increased significantly over the past several decades. For instance, there were only 284 generic drug approvals in 1985, but between 2013 and 2018, that number skyrocketed to 588 generic drug approvals per year.

The various fast track and rapid approval programs used by the FDA to expedite new medications and make them available to consumers more quickly has also increased over the past several decades. According to the FDA, these accelerated approval programs are meant to facilitate “the development and expedited review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.” In 2018, however, a whopping 81% of new medications benefited from at least one expedited approval program.

Less Data Required for Drug Approvals

At the same time as the FDA ramped up its efforts to expedite drug approvals, the percentage of new drug approvals supported by at least two pivotal clinical trials dropped from 80.6% between 1995 and 1997, to just 52.8% between 2015 and 2017. The time it took to review these new medications also decreased a great deal. In 1983, the FDA review time was more than three years, but by 2017, it had dropped to less than one year.

“The number of expedited development and approval programs has expanded greatly since 1983, reducing the amount of evidence available at the time of approval and increasing uncertainty about the existence or amount of clinical benefit,” the researchers concluded. They also noted that, “The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.”

It may appear at first glance that the FDA making an effort to review and approve life-saving medications more quickly would serve to benefit consumers who need these drugs. However, if new medications aren’t being properly researched and tested, they could pose a serious risk for users.

Drugs Recalls Over Serious Side Effects

We have seen a number of drugs recalled over the past several months, due to unforeseen problems that have put users at risk for devastating and potentially life-threatening side effects. Since September 2019, nearly every version of the popular heartburn drug Zantac (ranitidine) has been recalled due to unacceptable levels of N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen, or a substance that could cause cancer in humans, and it is believed that ranitidine can naturally produce potentially dangerous levels of NDMA as a byproduct of the body’s digestion process. Dozens of other medications have been subjected to recalls over the years, after it was discovered that the medications could put users at risk for serious injuries, illness or even death.

Lawsuits Against Drug Manufacturers

Lawsuits filed against the makers of Zantac and the countless other pharmaceutical drugs that have been linked to serious side effects allege that the drug makers knew or should have known that their medications could pose a risk to consumers, yet marketed their products as safe and effective without warning about the potential risks. If this trend of drugs being approved by the FDA through less rigorous approval processes continues, the unsuspecting people who use these drugs will continue to serve as unwilling test subjects for drug manufacturers.