Last week, the House of Representatives passed the “21st Century Cures Act.” Sounds great and progressive, but what it really means is that pharmaceutical companies will have much easier access to fast-tracking their drugs to consumers without proper testing and proof they even work.
For the past generation, the U.S. Food and Drug Administration has been speeding up the approval process for new drugs and medical devices. One of the most notorious examples of this is the 510(k) Clearance process. This pre-approval process allows drug makers and medical device manufacturers to by-pass the usual rigorous clinical trials and testing if they can demonstrate that the new product is “substantially similar” to an earlier product already on the market with FDA approval. The results have been devastating to consumers. Poorly-tested medical products rushed through the approval process in this way have caused injuries and deaths to millions of people, without any real benefit to the consumers.
On a positive note, by “fast-tracking” the approval of “blockbuster” drugs, patients may get potentially life-saving treatments sooner. However, the key word here is “potentially.” As often as not, these drugs have done little good extending or raising the quality of life in patients with serious and terminal diseases. Instead, they simply have cost users their life savings while enriching the pharmaceutical companies.
Given the power of the pharmaceutical industry, it comes as little surprise that the “21st Century Cures Act” passed the House of Representatives 344-77. According to two physicians writing in the New England Journal of Medicine, the 21st Century Cures Act was “championed by the pharmaceutical, biotechnology and [medical] device industries.” In addition to streamlining the approval process, the bill also extends funding for the National Institutes of Health (NIH) and provides the FDA with well over half a billion dollars over the next five years – which will be used to implement the new, faster drug approval process. It’s also touted by GOP Representative Fred Upton of Michigan as a bill that will create jobs. However, authors of the NEJM editorial are concerned. They believe the new process will compromise drug safety while allowing drugs onto the market that may have little or no positive effect on patient outcomes, due to substantially lowered standards for drug and device approval.
The NEJM editors are likely to be correct, given the history of the pharmaceutical and medical device industries. These corporations have demonstrated repeatedly over the years that maximizing profits is their sole concern. If patients get hurt or die in the process and they wind up having to pay a few million in judgments, it’s considered part of the cost of doing business.
The 21st Century Cures Act, if signed into law, is likely to pull us all back into “another era” during which dangerous, untested drugs could make their way onto pharmacy shelves and make a great deal of money for their manufacturers – but not before patients have been injured and killed as a result.