House Passes ‘Cures’ Bill to Hasten Drugs to Market
- White House Gets More Precise About Precision Medicine
- Bill Aims to Expand Drug Indications Minus Randomized Trials
- FDA Approval of ‘Novel’ New Drugs Up Sharply in 2014
THIS IS VERY BIG We have yet to seen what the Senate and what come out of committee but it appears the stars are aligned, as written in my book, from a major infusion of cash to NIH specifically to get drugs and device more quickly to the market as well get clinical trials- still the gold standard for new drug/device approval into the community more. Yes, this is risky if too lose provisions are written or implementation leads to less than essential scrutiny of every new claim. the FDA will need to be on its toes, but again as written in my book- they are not the enemy DR RYAN
The House of Representatives today overwhelmingly passed a bipartisan bill designed to speed up the development and approval of new drugs and medical devices. To help make that happen, the bill would boost funding for the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA).
The vote in the Republican-controlled chamber was 344 to 77.
The legislation, called the 21st Century Cures Act, enjoys support from the White House as well as medical societies such as the American College of Surgeons, disease groups such as the American Heart Association, and medical schools. However, a few groups in the healthcare field warn that the measure could allow unsafe, ineffective drugs and devices to reach the market in the name of expediency. A recent editorial in Modern Healthcare magazine dubbed it the “21st Century Quackery Act.”
One controversial measure would lessen the reliance on randomized clinical trials, considered the gold standard for assessing safety and efficacy. The provision would require the FDA to evaluate how evidence from “clinical experience” — that is, from observational trials, clinical registries, insurance claims, and FDA safety surveillance — might be used to approve a new indication for a drug already on the market. Likewise, in another broadening of scientific evidence, the bill would allow the FDA to consider registry data, studies published in peer-reviewed journals, and data collected outside the United States in its decisions on medical devices.
“The bill greatly benefits the pharmaceutical industry [and] medical device manufacturers,” said Diana Zuckerman, PhD, president of the National Center for Health Research, a think-tank focused on women, children, and families. “But by lowering standards for drugs and devices, it is likely to add billions to the cost of Medicare and all health programs without benefitting most patients. And it is an added burden on patients and physicians, because they need to decide which of the new treatments to try, without knowing if they are safe and effective.”
An opposing view comes from Julie Vose, MD, president of the American Society of Clinical Oncology (ASCO). In an ASCO news release issued today, Dr Vose called the 21st Century Cures Act “monumental legislation that will accelerate the discovery, development, and delivery of promising new treatments to people living with cancer.”
The bill, she said, advances the twin disciplines of Big Data, which gleans knowledge from large data sets such as patient registries, and precision medicine, which tailors treatments to a patient’s molecular and genetic profile. ASCO has launched Big Data and precision medicine initiatives, she said, and the 21st Century Cures Act will support these efforts.
Crude Oil for Medical Breakthroughs?
Although supporters of the Cures bill were encouraged by its landslide approval in the House, the legislative finish line is a long way off. The Senate is considering a similar measure, but it may not take a vote until much later this year.
When a Senate vote does occur, money matters may muck things up. The controversy is not so much about the spending, but how it’s offset elsewhere in the budget.
The House bill would increase the NIH budget by $8.75 billion over 5 years. That’s less than the $10 billion originally proposed, but NIH supporters are still gratified. In addition, the FDA would receive an extra $550 million over the next 5 years. Lawmakers wrote in that figure after FDA leaders said their agency would need extra money to carry out new responsibilities created by the Cures bill.
To help pay for itself, the bill authorizes the sale of 64 million barrels of crude oil over 8 years from the nation’s Strategic Petroleum Reserve (SPR), which would yield roughly $5.4 billion, according to the Congressional Budget Office. That budget-balancing tactic has raised eyebrows among some political conservatives. Reuters reports that Sen. Lisa Murkowski (R-AK), who chairs the Senate Energy Committee, opposes selling SPR oil for any purpose other than national energy security.