Reasons For Concern With 21st Century Cures Act
Just when we thought nothing could pass in a divided Congress, a proposed law referred to as the 21st Century Cures Act made its way through the U.S. House of Representatives and is slated to go to the Senate. It might well soon become law since President Obama has indicated his agreement as well as some Democrats but the law as framed has aroused the ire of other Democrats including but not limited to populists, Bernie Sanders and Elizabeth Warren.
This is why the division and here is why it matters to average Americans like you.
The law as originally proposed would have contained substantially more funding for consumer related measures, like funding for Alzheimer’s and cancer, than it does now. Although there is funding for Alzheimer’s research and cures as well as some funding for the Joe Biden “Moonshot” to find cures for cancer, this is much less than in the original bill and would need to take funding from other sources.
Also, in its current form, pharmaceutical companies would be able to secure approvals for new drugs and devices much more readily than at present. It depends on your source whether this is considered bad but as a matter of public health and safety it raises a serious issue. As described in an article, “Cures Act Is Bad Medicine for NIH, FDA,” the Cures Act would severely undermine the FDA by altering its drug and medical device approval process to value speed over accuracy and profits over health and safety. In response to corporate complaints that FDA approvals are costly and time-consuming, the bill would reduce standards, streamline reviews, secure automatic approval for certain devices and drug therapies without rigorous screening, and allow the use of “real world” evidence of drug effectiveness rather than more credible randomized clinical trials. Third parties could certify certain medical devices, avoiding the FDA entirely. Even articles from medical journals could be used as evidence, despite an uptick in retractions in these publications in recent years…”
Another concern is the bill contains no provisions for relief from the high cost of prescription drugs. If a pill or therapy costs $1,000 and the consumer cannot afford it and her insurance does not cover it, its availability at high cost is out of reach.
Think of it this way. Suppose you are invited to holiday dinner and your cousin, Ernest, sits at the table and is given the major share of the turkey and over half the pumpkin pie. You are offered broccoli, carrots and a tiny piece of cake. Do you take what is offered grateful that you received something, voice your disapproval of the imbalance, or call off the dinner? This is the dilemma of consumers who want more. Alzheimers and cancer, in particular, are major concerns and will be costly in the future for Medicare and Medicaid so it would make sense to address the problems with more seriousness now. There is some funding for opioid addiction and mental health as well as some relief for hospitals and medical training. So the law has some good points.
Regarding the issue of drug safety, ironically I had some experience in the past. While working my way through law school as a law clerk several years ago I had the opportunity to review research for a drug application that had been approved many years before but now seemed to result in a higher incidence of a rare form of cancer. The studies read like personal accounts from a family physician indicating that one patient reacted favorably and another did not. There was little or no scientific method applied or control of variables. This is what the opponents are trying to prevent.
On the other hand, more recently my daughter and I had experience requesting an off label use of a medication for a serious condition where insurance was declined for lack of a controlled study and there never would be one. The condition was too rare.
The big winners for the 21st Century Cures Act, if passed, will be the pharmaceutical companies. Described as “one of the most lobbied bills in recent history,” the jury is still out on its long range effects.
About the Author Janet Colliton
Esquire, Colliton Law Associates, P.C. Janet Colliton has practiced law for over 38 years, 37 of them in Chester County, Pennsylvania, a suburb of Philadelphia. Her practice, Colliton Law Associates, PC, is limited to elder law, Medicaid, including advice, applications and appeals, and other benefits planning including Veterans benefits, life care and special needs planning, guardianships, retirement, and estate planning and administration.