Triangle health care companies are anticipating a boom in research and funding from sweeping Congressional legislation signed into law last week that aims to lower the cost of medical research and to ease drug approvals.
Clocking in at nearly 1,000 pages, the 21st Century Cures Act is deemed one of the most comprehensive laws Congress has passed since the Affordable Care Act was adopted in 2010. Unlike the contentious ACA, this year’s law was bipartisan and lauded by President Barack Obama, despite objections that it was a giveaway to the pharmaceutical industry and didn’t require drug companies to address an ever-pressing problem: soaring drug prices.
The new law earmarks $6.3 billion for biomedical research and other programs, and clears the way for the Food and Drug Administration to require less data for drug approvals if the drug is already approved for other conditions. For regulatory review of medical devices, the law says developers can apply the “least burdensome” standards to establish product safety.
“I’ve read this bill in full, all hundreds of pages of it, last week, because it’s such an important and revolutionary bill,” said Jeff Wolf, chief executive of Heat Biologics, a 20-employee developer of cancer immunotherapies in Durham.
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Executives at Triangle biomedical firms said the the law would be a catalyst for their industries.
“This will help drive even more investment into this space,” said Patrick Daly, CEO at Cohera Medical, a surgical product maker that employs 22 people in Raleigh. “If there’s a more collaborative regulatory environment, I think it could take more time off our approval process.”
Some Triangle companies supply products and services to the industries that could benefit directly from the new law. One such company is bioMerieux, which employs 800 people at its Durham office, the French company’s America’s regional headquarters and manufacturing site for blood culture bottles. BioMerieux also makes instruments and reagents for bacterial testing that is expected to benefit from increased demand as biomedical firms develop new diagnostic tests in response to new standards established by the law.
“The legislation makes it easier to develop tests and deliver them to doctors and hospitals,” said Sam Bozzette, bioMerieux’s vice president for clinical affairs. “We will be developing more products and getting more products approved.”
Another company that could potentially benefit is Morrisville device maker TransEnterix, whose surgical robot Senhance is approved in Europe and is being readied for submission to the FDA for approval in this country. TransEnterix is sitting on reams of performance data for the robot that may not have to be replicated in full in this country under new protocols.
“Many devices, such as our robotic surgery system, are safely and effectively used for years in Europe and elsewhere before coming to U.S. patients and doctors,” TransEnterix said in an emailed statement. “The specific provisions of a least burdensome pathway at the FDA along with a push to follow global consensus standards will help medical device companies move through the U.S. approval process.”
Despite its broad support, the law met severe criticism from some lawmakers. The loudest critics included Democratic Sen. Elizabeth Warren of Massachusetts and Sen. Bernie Sanders of Vermont, as well as the the advocacy group Public Citizen. They warned the law will weaken federal oversight, compromise drug safety and enrich drug companies.
The law next will go through the lengthy process of developing the federal rules that explain the guidelines and provisions in the legislative language. The process of crafting regulations is expected to take many months.
Heat Biologics expects to benefit from the federal research funding to develop drugs, combination therapies, biomedical technology and to fund clinical trials, particularly for a Zika virus treatment under development. “This could enable us to do things that we can’t ordinarily do today,” Wolf said.
Wolf said he was encouraged by the law’s flexibility for clinical trial design and data analysis, which will allow using alternative measures to assess a drug’s effectiveness. He said that with cancer treatments, the standard measure for effectiveness is typically patient survival rates, which can take years to determine. Wolf said one potential change in documenting the effectiveness of a cancer drug is measuring tumors as they shrink from effective therapies.
“This will be much more cost effective and much faster, and will allow us to generate better results,” Wolf said.