Fda Drug Approval Process Criticism and Risks

Jul 20, 2018 | Product Liability

As consumers, we all rely on government regulations and inspections to help insure the safety of the food we eat, the cars we drive, the toys we buy our children. But the safeguards we expect may be flimsier than we think, in one particularly critical area: the development of new pharmaceutical drugs and medical devices, many of which are now reaching the marketplace with minimal testing and weak regulatory oversight.

Two recent investigative reports published by distinctly different media outlets, the Atlanta Journal-Constitution and the online watchdog ProPublica, provide disturbing evidence that efforts by the Food and Drug Administration to make it easier for companies to bring new products to market may be jeopardizing patient safety. Demands for innovative ways to cut through the red tape of regulatory review have led to patients being exposed to a bevy of pricey drugs of dubious efficacy, with serious (or simply unknown) side effects, as well as implanted medical devices with a high rate of defects or failure.


The push to fast-track new drugs and devices has its roots in longstanding complaints, from patient advocates as well as industry, that the traditional FDA approval process was too slow and cumbersome. It can take eight years of more for a new “wonder drug” to make its way through the established gantlet of clinical trials, a process that contributes to the high price of the medication and can discourage smaller companies from pursuing promising frontiers of research. Speeding things up, the critics argued, would help encourage the development of experimental, potentially life-saving therapies, such as new cancer drugs.

In response, the FDA has created various forms of “expedited review” that allow drugs to get to market faster. Some experimental treatments now require only one clinical trial that shows a benefit to patients, rather than two. The standards for a “successful” trial have changed, too, allowing the industry to point to certain proxy indicators, such as the drug’s ability to shrink tumors, rather than focusing on long-range results such as survival rates. Drug companies can also obtain quicker approval of new products by agreeing to study their effects over a period of years after they are released, essentially gathering data on safety and benefits that previously had to be compiled before approval.


The result? According to the ProPublica report, the FDA now “reviews and approves drugs faster than any other regulatory agency in the world.” But all that speediness also signals a profound cultural shift inside the FDA, as it becomes more industry-friendly and less vigilant about the risks, as the article puts it, of “green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.”

Reporter Caroline Chen found that Big Pharma now pays for 75 percent ($905 million) of the FDA’s annual budget for scientific review of branded and generic drugs. Many of those who appear before the agency to testify in favor of new drugs are physicians, caregivers, and others who’ve received consulting fees or other forms of compensation from the pharmaceutical company involved. Some public health experts have expressed concerns that the FDA is now essentially partnering with industry to such an extent that it badly skews the approval process in the drugmakers’ favor.

And the drug companies stand to make considerable revenues on costly new drug therapies. Chen cites several disturbing examples of problematic medications that have won FDA approval, including Nuplazid, a drug for treating Parkinson’s that failed two clinical trials before demonstrating “minimal benefit” in a third. Since its introduction in 2016, the agency has logged 6800 reports of adverse events and 887 deaths, a figure that Chen suggests may be an undercount. Yet the drug remains available, at a cost of more than $33,000 a year. Other drugs with a history of severe side effects have won fast-track approval, sometimes over the objections of lower-level FDA staffers and despite the limited scope of the clinical trials involved.


The regulation of medical devices, from pacemakers and artificial joints to surgical mesh, often involves even less scrutiny than the drug approval process, notes an eye-opening report in the Atlanta Journal-Constitution. Most people assume that the FDA requires rigorous testing of new devices before they are made available to the public. But that’s not always true. While some testing may take place using machines or animals, medical device developers can avoid testing for safety on humans through a process know as 510(k), which allows a company to forego lengthy trials if the product is considered substantially equivalent to others already on the market.

That streamlined process, the report notes, is only supposed to be available for devices categorized as moderate-to-high risk. But in some cases, the devices turn out to be far riskier than the preliminary data indicated. Defects, design flaws, equipment failures, and other problems with the devices (and, in some cases, with the “substantially similar” devices that they’re based on) may only surface years later, after the devices have already been surgically implanted in thousands of patients.

Industry advocates maintain that the number of devices plagued with such issues is small. But that’s of small comfort to those patients who have suffered serious, sometimes fatal health problems as a result of defective devices or for those who’ve endured painful revision surgery. The current system the FDA has for detecting the problems relies heavily on reports from the manufacturers themselves; in many instances, the push for a recall or more stringent standards comes only after enough patients have pursued lawsuits in an effort to seek compensation for their injuries that the problem can no longer be ignored. Reporter Ariel Hart notes that more than 45,000 lawsuits are pending against 13 device makers. “I think it’s a tragedy and a travesty that frequently these things get off the market because first people get hurt and then lawyers pursue cases,” one attorney told her.


If you or a loved one have suffered injuries as a result of a dangerous prescription drug or a failed medical device, you may be entitled to compensation. The product liability attorneys at Franklin D. Azar & Associates have helped thousands of Americans who have been harmed by defective pharmaceuticals and medical devices. We are currently investigating several products associated with recalls, adverse events, and dangerous side effects, including Depuy Attune Knee Replacements, St. Jude Defibrillators, Xarelto, and Eliquis. Call us or contact us here for a free, no-obligation consultation.