This post was contributed to ConsumerSafety.org by Jen MacCormack.
A sweeping new health care bill was recently approved by both houses of the United States Congress. The 21st Century Cures Act is intended to funnel over $6 billion in funding towards areas of medical research and innovation. It is likely to stir up big changes in the world of pharmaceuticals and medical devices.
The Cures Act has been a long time in the making. Lobbyists from the pharmaceutical and medical device industries strongly supported and lobbied for the bill.
Apart from aiding research efforts, the bill includes money to address the following needs:
- Mental health reforms
- Opiate addiction
- Health information technology
How the Cures Act Affects Drug and Medical Device Companies
The biggest names in the medical device and pharmaceutical industries have been lobbying for some of these changes for years. The lobbying efforts intensified as the Cures Act took shape.
Throughout the past two years, interested parties spent over a quarter billion dollars on lobbying. It appears to have paid off. With this win, manufacturers of drugs and medical devices stand to save billions of dollars over the next decade.
The Cures Act gives the U.S. Food and Drug Administration (FDA) more discretion over studies that manufacturers must perform as they bring new drugs or devices to market. This bill reflects an understanding of the changing world of biotechnology and individualized medicine.
It is a shift towards flexibility in the regulatory approval process for new and innovative treatments. Many within the FDA have been hoping for this change. This bill will help streamline the drug approval process in the country.
Drug and Medical Device Companies and the FDA
Currently, drug approval is faster and less costly in the European Union than in the United States. New drugs can take over a decade to make their way to market. A new drug must work through the research and development pipeline and then receive FDA approval before coming to the consumer market.
The process costs drug companies on average $2.5 billion for every drug they develop. Pharmaceutical and biotech companies argue streamlining the approval process can make the drug development process faster and more efficient. According to these companies, faster and cheaper development of new treatments will ultimately mean better access for patients.
The Risks of the Cures Act
However, there is an inherent risk in removing some of the requirements in the testing phase. It's difficult to know where streamlining ends and corner-cutting begins. Some physician groups worry the impact to patient safety could be disastrous.
It's very clear that in the era of 21st Century medicine, one size can't possibly fit all when it comes to new devices and drugs. But, with so much lobbying money behind the passage of this bill, one wonders whether allowing the industry to decide on the fit is in a patient's best interest.
Medical devices and pharmaceuticals are still subject to federal oversight, even with the passage of the new Cures Act. In fact, the bill includes extra funding for the FDA to develop and manage the new programs associated with the Cures Act.
The FDA will receive another $500 million for its budget through 2026, along with increased hiring power. Even so, critics argue the amount is insufficient to cover the cost of the increased workload. It doesn't allow for any hope of improving some of the FDA's long-standing problems.
How the Cures Act Improves Patient Care
A portion of the bill's funding will go to the National Institutes of Health (NIH) to back more biomedical research in neuroscience, genetic medicine, and cancer prevention and treatment. The $4.8 billion would support research at other institutions as well. The grant money will be doled out in portions over the next decade. This is an encouraging sign that lawmakers on both sides of the aisle agree that funding basic medical research needs to be a national priority.
The Cures Act also sets aside funding for mental health and treatment of substance abuse. $1 billion is set aside to deal with the national problem of opiate addiction. The money will mostly be used to increase access to rehabilitation and treatment programs.
The language of the bill also strengthens the mental health parity law. This law requires health insurance companies to provide coverage for psychiatric illnesses just as they do for physical ones. While that law already exists, many patients requiring psychiatric hospitalizations often find themselves left with the bill as insurance companies argue inpatient care wasn't medically necessary.