As many of our readers will certainly be aware, there has been a great deal of media coverage and discussion about a piece of legislation moving through Congress that is known as The 21st Century Cures Act. Here’s a link to the current draft of the legislation (issued at the end of April this year); and here’s a link to a much shorter summary of the the legislation, published on the blog site of RAPS (the Regulatory Affairs Professionals Society).
Much of the ongoing coverage and discussion has been very positive in nature, and there is absolutely no doubt that some of the recommendations made by this bill’s sponsors and backers are potentially beneficial in terms of things like funding for that National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA), whose budgets have been severely affected by sequestration over the past few years. In addition, it should be noted that the current version of the legislation has eliminated a significant number of the most controversial issues that were included in a prior (and much longer) version of the legislation, issued earlier in 2015. However, …
There have been a number of concerns expressed by patient organizations and others about a piece of legislation that appears to have been heavily influenced by industry. Indeed, despite the efforts of many patient-centric and other organizations to bring greater balance to the language of 21st Century Cures during a number of public hearings and other opportunities to comment, the bill as written is still unequivocally designed to benefit the interests of the biopharmaceutical, medical device, and diagnostics industries that put great effort behind the content of this bill.
A new perspective piece by Avorn and Kesselheim in this week’s New England Journal of Medicine (“The 21st Century Cures Act — will it take us back in time?“) offers a detailed assessment of some of the concerns that are still being raised about the content of this piece of legislation, as currently written.
The authors call attention to both potential upsides and potential downside risks associated with the 21st Century Cures Act, and it is important to appreciate that, as is often the case, the Devil will be in the details of how this legislation is actually interpreted if it is passed into law. The opinions of the NIH and the FDA and others were very definitely taken into account by the bill’s sponsors during a long development process, so such organizations are well aware of the potential implications. Senior administrators at the NIH, the FDA, and elsewhere may well, in fact, believe that they can live with and manage the downside risks noted by Avorn and Kesselheimer.
From the perspective of the disinterested observer, what is actually most interesting about the 21st Century Cures Act is the way that lobbying by well-funded interest groups is so highly influential today in the detailed language of American healthcare legislation. This is not necessarily always “a bad thing”. On the other hand, it does continue to call into question whether our elected legislators are always able to differentiate well between the best interests of the people they were elected to represent and the best interests of those who are helping to fund their election and re-election.
There is almost no doubt at all that President Obama will sign the 21st Century Cures Act into law if and when it reaches his desk. What is of much greater interest at present is whether the House and then the Senate will be willing to move the legislation forward in anything close to its current form. It is a piece of legislation that contains some very good and sound ideas … along with some ideas that are — not unreasonably or unsurprisingly — much more worrisome (at least to some).