It’s been a busy summer for health care laws and regulations! We’ve already mentioned some news out of CMS (see our posts about changes to the two-midnight rule and coverage of end-of-life planning); this time the news comes from Capitol Hill.
Last month, the House passed (by an impressive 344-77 bipartisan vote) the 21st Century Cures Act. The goal of the Act is to increase medical innovations and make new treatments available to patients sooner.
Many of the bill’s provisions are intended to make the FDA’s drug and device approval process easier and faster, particularly for the development of new antibiotics, which is a critical public health need. These provisions include changing the standards for what kind of data can be considered in the approval process.
The bill also includes incentives for the development of treatments for rare disorders (also referred to as “orphan drugs”). One such incentive would extend the patent protection for orphan drugs. Another provision would extend the existing priority review voucher program for rare pediatric diseases. A priority review voucher gives a company that develops a desired drug the right to have another product of its choice reviewed by the FDA on a fast-track, or priority, basis; because this gets the product to market faster, it’s estimated that priority review vouchers can translate into millions of dollars in additional sales.
Although the bill has received widespread support from both sides of the Congressional aisle and from both the pharmaceutical industry and patient groups, the Act is not without its critics. They argue that the regulatory process isn’t the main reason we lack treatments for many diseases, and that the real bottleneck is in the development process, before drugs are submitted for approval. Moreover, they say that the legislation trades safety for speed, as lowering the standards for the approval process puts patients at risk of unsafe or ineffective drugs. And they argue that the bill gives perks to the pharmaceutical industry at the expense of patients. For example, extended patent protections mean that generics will be slower to enter the market, keeping drug prices higher for longer. Indeed, the Congressional Budget Office estimated that this provision could increase spending on prescription drugs by $869 million over ten years.
One part of the bill that has been spared criticism is the allocation of almost $1.9 billion in additional funding to the National Institutes of Health for biomedical research. Federal funding of basic research has been essential to the development of many breakthrough treatments over the last several decades and is seen as the best way to create future breakthroughs.
The legislation still has to work its way through the Senate, which is moving more slowly on the initiative. It might make it through the Senate’s Health, Education, Labor and Pensions Committee by the end of 2015. But the Act may look quite different by the time it emerges.