Understanding the Controversies Over a Groundbreaking New Health Care Law

Within days of the Supreme Court’s decision to save rather than eviscerate the Affordable Care Act, the House of Representatives did something surprising: They passed a groundbreaking health care law with strong bipartisan support. That sounds like good news. However, this groundbreaking health care law is almost as controversial as the previous one.

How is it that the Democrats and Republicans in the US House of Representatives, who agree on so little, managed to agree on a bill called the 21st Century Cures Act? The spokespersons for the bill, Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), claim that the support reflects a thoughtful, bipartisan working relationship.1 Critics of the bill offer other explanations: 1) most Congressional staff never read the 362-page bill (which in addition to being lengthy was filled with medical jargon that members and staff did not understand), 2) Republican supporters had a powerful lobbying and negotiating strategy that overwhelmed Democrats, and 3) corporations used patient groups to do their lobbying.

Here are some of the details that will help you judge for yourself.

The 21st Century Cures Act passed the US House of Representatives in July amid praise from hundreds of patient organizations, well-known charities, and universities. These organizations focused on one page of the bill, which provides almost $9 billion of additional funding for the National Institutes of Health (NIH) over 5 years, and on 61 pages that provide research prizes and grants for new scientists. They were optimistic that the bill would provide “cures”—or at least treatments to prolong life—for desperate patients.

Although greatly outnumbered, well-respected researchers and public health and consumer advocates raised alarms that the bill would also drastically lower Food and Drug Administration (FDA) approval standards. More than 150 pages specify drastic changes in how the FDA decides which drugs and devices can be sold in the United States. For example, the proposed law criticizes the gold standard of randomized double-blind clinical trials as old fashioned and urges the FDA to rely on other types of evidence, such as preclinical studies (eg, rat studies and test tube research), case histories (detailed anecdotes about individual patients), and clinical experience (defined in the bill to include anecdotal information from small numbers of patients).

Those changes would make it easier for drug and medical device companies to sell more of their products more quickly, but unfortunately many of those products will not cure patients, or even help them feel better. The history of the FDA is a history of strengthening legislative safeguards in response to tragedies like thalidomide, diethylstilbestrol (DES), and the Dalkon Shield intrauterine device. Those tragedies resulted in stronger standards for proving safety and efficacy that the proposed law would weaken or eliminate. Critics charge that instead of moving us into the 21st century, the bill takes us backwards.

The 21st Century Cures Act would also take away the FDA’s authority to ensure that innovative medical software is accurate (Section 2241). Doctors are becoming more dependent on electronic medical records that remind them about a patient’s medical history and warn them about drug interactions and other dangers. People’s lives can depend on that software accurately telling patients and doctors what tests a patient needs, when they need an insulin injection, and other potentially life-saving alerts. If software isn’t regulated, the company is the only one checking its accuracy and reliability. The justification for eliminating the FDA’s authority is that the agency’s review process might delay availability of new software by a few months. But deregulation wouldn’t just eliminate independent review of the software before it is sold—it would also eliminate mandatory public reporting of life-threatening and fixable malfunctions of software already on the market. Under the proposed law, if a product fails and a patient dies, there would be no one to ensure that patients and doctors are warned of those risks. Without that monitoring and oversight mechanism, it would take years before many product flaws became obvious and were therefore corrected.

The proposed law would allow companies to give doctors expensive gifts in the form of tuition and speaking fees for continuing medical education courses at exotic locations, without making those gifts public (Section 3041). This creates an enormous loophole in the Physician Sunshine Act that is current law, passed 3 years ago by Congress to make gifts public in hopes of discouraging physicians from accepting gifts that could influence treatment decisions.

Under current law, new medical devices such as hips, spinal implants, and even many life-saving cardiac devices are almost never required to be proven safe or effective in clinical trials.5 The 21st Century Cures bill would lower the standards even more: Instead of having to prove to the FDA that changes to a previously approved high-risk device do not compromise safety or effectiveness, device companies could pay a third party to review their quality control mechanisms to determine if the company could make changes in the design or materials without applying for FDA approval (Section 2221). Some point out that this creates a strong conflict of interest. Others compare it to the fox paying a friend to guard the henhouse.

The proposed law would also worsen the epidemic of antibiotic resistance. Although it “encourages the development and use of new antimicrobial drugs,” it does so by relying on preliminary studies of small numbers of patients for FDA approval of new drugs (Section 2121). It then encourages hospitals to prescribe those poorly tested new drugs for Medicare patients. Lower standards and high use of unproven drugs by the elderly puts lives at risk. And, encouraging the overuse of new antibiotics instead of saving them as a last resort will spur more superbugs in our hospitals.


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