Did you know that pharmaceutical companies pay to have their drugs and medical devices reviewed by the FDA? Back in 1992, the FDA was overwhelmed with approval requests and grossly underfunded, so the Prescription Drug User Fee Act (PDUFA) was enacted to generate much needed income to speed the process along. The benefit was thought the be threefold: 1) the government agency could get the additional help it required without further burdening tax payers; 2) patients could have quicker access to needed medications, and 3) drug companies could get their medication to market sooner to create profit from their investment. But now looking in hindsight, is this a conflict of interests?
So how does this process work? First of all, a pharmaceutical company spends millions of dollars creating and testing their drug or medical device to prove that it is safe and to determine the risks that could harm patients. Since the drug companies have already invested a ton into developing their product, it leaves one to wonder how neutral these companies can be when interpreting the effects and potential problems that could be associated with their drug. Even third party scientists aren’t fully immune to the power of the big pharma company that is hiring them to test the medication. For example, in 2006 GlaxoSmithKline submitted a report that stated that when they compared their new drug Avandia to three existing diabetes drugs, Avandia was proven more effective. “We now have clear evidence from a large international study that the initial use of [Avandia] is more effective than standard therapies,” boasted the senior vice president of GlaxoSmithKline, Lawson Macartney, in a news release.However, the scientists who were reporting these results were hardly unbiased. The trial was funded by GlaxoSmithKline and each of the 11 authors received compensation from this company. Furthermore, four were employees and who held stock in the company and seven others were academic experts who had received grants or consultant fees from GlaxoSmithKline. Later the FDA attributed Avandia to 83,000 heart attacks, a risk that the drug company supposedly knew about and didn’t report. The Avandia litigation ended up being one of the largest drug lawsuits ever because of massive problems linked to cardiovascular issues after usage.
So once the FDA receives an application from a pharma company, the Center for Drug Evaluation and Research (CDER) reviews the data. CDER assesses the evidence from the lab tests submitted by the drug company which “proves” that the drug is “safe and effective for its intended use”. The CDER team is made up of physicians, statisticians, chemists, pharmacologists, and other scientists. According to the FDA, “The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.”So simply put, the FDA approves reports that are funded by the pharmaceutical companies that have invested millions of dollars into their drug.
An important part of the approval process is first having the pharma company pay to have their drug or medical device approved. Here are some of the costs for 2018:
One report determined that drugs approved by the FDA after the passage of PDUFA were more likely to be warned, withdrawn from the market, or receive a black box warning than medications approved prior to its enactment (26.7 per 100 drugs vs 21.2 per 100 drugs at up to 16 years of follow-up).” While drugs are being approved more quickly, it may not be in the best interest of the consumers.Clearly the FDA needs to reassess PDUFA to ensure that patients get medications that are thoroughly tested and that people are put above profits. Until that happens, we will continue to see innocent lives become collateral damage.
