CURES Act : House Passes Largest Bill Since Obamacare Save

The 21st Century Cures Act has become one of the most-lobbied health care bills in recent history, with nearly a half billion dollars being spent on both sides - those for and against the bill.

The bill is supposed to streamline the approval process of prescription drugs and medical devices by the FDA.

The purpose of this legislation is to reduce the bottlenecks in the regulatory process that allow the development of new drugs. The Act would trim regulations by allowing for shorter clinical studies involving fewer individuals for certain kinds of drugs. It would also allow for expanded use of surrogate endpoints (e.g., biomarkers) as evidence of the efficacy of drugs. Case studies, patient registries and existing health care data can also be utilized to speed up clinical trial endpoints. Opponents of the Act have expressed concerns that these reforms will compromise patient safety, moreover many critics claim that the bill does little to curb the rising cost of medications.

Supporters of the bill, including medical device and pharmaceutical companies, have argued their products are expensive because the FDA's requirements are too burdensome and time-consuming. Hence, it takes a decade of research and $1 billion to bring a single drug to market.

While it passed the House in July of 2105, it has since been the subject of numerous modifications.  The bill was voted upon yesterday and unanimously passed the House, but not without controversy and concern.

The House overwhelmingly passed the 21st Century Cures Act by a vote of 392 to 26.  The multibillion-dollar, 1,000-page bill took two years to negotiate. The upside is that if approved by the Senate, the NIH will receive $4.8 billion in additional funding over the next 10 years. The cash is intended to fund three landmark big science initiatives of President Obama’s time in office: The cancer moonshot, the BRAIN Initiative and the Precision Medicine Initiative. Moreover, $1 billion  is earmarked for tackling the opioid epidemic; and provisions that are meant to help pair Americans who suffer from serious mental illnesses with available psychiatric beds.

The funding boost for NIH ensured the bill secured bipartisan support—it passed in the House by —even though lawmakers and observers have misgivings about aspects of the legislation.

There are several aspects of the renegotiated bill that are contested.  Including the regenerative medicine accelerated approval pathway and an FDA fast-tract for new antibiotics, antifungals, and possibly other drugs via new and faster pathway called the “limited population antibacterial drug” pathway. The same accerated approvals will be used by device manufacturers.

Through this expedited pathway, new medicines would be approved and labeled for use in patients with “unmet medical needs,” even though these drugs had never been tested in these specific patient populations.

Many parties are skeptical about whether these new accellerated pathways will ensure efficacy and safety.

The CSRO (Coalition of State Rheumatology Organizations) has compiled a comparison table on the CURES act.