House passage of a biomedical bill on Wednesday is seen as being a big boost for startups and emerging companies in drug development, says the National Venture Capital Association. And that bill could be major news for the Triangle.
One of the nation’s biggest life science hubs is in Research Triangle Park. the region ranks among the leaders in the U.S. along with Boston, Silicon Valley and others. Biotech startups and emerging entrepreneurial companies traditionally rank among the leaders in venture funding for the state with much of that investment taking place in the Triangle.
The House easily approved what The Associated Press describes as a “sweeping biomedical bill” that it says would help drug and medical device companies win swifter government approval of their products, boost disease research and drug-abuse spending and revamp federal mental health programs.
“On behalf of our nation’s life science investors who since 2006 have collectively invested over $101 billion into 4,494 companies working on cutting edge medical innovation, we applaud passage in the House today of the 21st Century Cures Act,” said Bobby Franklin, the NVCA’s CEO. “Increasing funding for NIH, advancing precision medicine, and improving the environment for the development of life-saving drugs and treatments is critical to ensuring the U.S. remains the global hub of medical innovation.”
The compromise, which envisions spending $6.3 billion over the next decade, was condemned by consumer groups and some Democrats as a present to drugmakers that promised only paltry spending increases for underfunded federal programs.
“As we celebrate this victory, we ask lawmakers to not lose sight of other reforms that can be made to support the growth of life science startups,” Franklin added. “Venture investment into the medical device and advanced diagnostics sectors continues to be under pressure due to the increased time, cost and uncertainty of developing new drugs, medical devices and advanced diagnostics because of the unpredictability of regulation and the uncertainty of reimbursement policies. And while improvements have been made in recent years, we do see room for further reform. We thank Chairman Upton and Rep. DeGette for their tireless leadership to advance the 21st Century Cures Act and ask Congress to keep the momentum going to create a more favorable environment for venture investment in life science companies.”
Objections were overwhelmed by an alliance among Republicans, many Democrats and the White House for a 996-page measure that bore wins for both parties. The Senate’s expected final approval next week would mark an uncommon episode of cooperation between the GOP-run 114th Congress — which plans to adjourn next week — and President Barack Obama in their dwindling days in office.
The vote was 392-26.
“We are on the cusp of something special, a once-in-a-generation opportunity to transform how we treat disease,” said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.
Not everyone agreed.
Rep. Rose DeLauro, D-Conn., said that while the bill contained “noble goals that I share,” its relaxation of some standards for federal drug approvals was dangerous and “neglects the very people clinical trials are meant to help, that is the patients.”
No. 2 Senate Democratic leader Richard Durbin of Illinois said he was “totally underwhelmed” by the bill’s extra money, and said its cuts in a disease prevention fund created under Obama’s health care law to finance new medical research displayed “a warped sense of justice.”
But Democratic hopes — and leverage — for winning more money and consumer protections faded with Republican Donald Trump’s presidential election triumph. Senate Majority Leader Mitch McConnell, R-Ky., flatly said his chamber will send the measure to Obama, and Durbin said he expected Senate passage.
In a written statement, White House spokesman Josh Earnest said the bill “is not perfect” but contains “advances in health that far outweigh these concerns.” He said the Senate should approve it quickly.
The bill includes an additional $4.8 billion over the next 10 years for the National Institutes of Health.
The medical research agency spends around $32 billion annually, and supporters complain that spending cuts imposed by Congress and rising research costs mean its budget has eroded in value since the early 2000s.
“A couple billion dollars doesn’t go very far in cancer research” over 10 years, said Lisa Plymate, a director of the liberal-leaning National Physicians Alliance.
Much of the NIH money would be for Obama’s precision medicine initiative, aimed at tailoring drugs for people’s genes and lifestyles, and research on cancer, a focus of Vice President Joe Biden, whose son Beau died of the disease in 2015.
The bill would also sharpen the federal focus on mental health efforts, such as creating new posts for government officials who would coordinate such initiatives. But it has little new money for those programs.
“We didn’t get everything we needed,” said Rep. Tim Murphy, R-Pa., sponsor of those provisions. “We’ll keep pushing that.”
The measure included funds and an accelerated Food and Drug Administration approval process for techniques aimed at regenerating cells. McConnell has supported those provisions, but critics have condemned the treatments as ineffective.
The Food and Drug Administration would get $500 million to streamline approval processes for drugs and medical devices. States would get $1 billion over the next two years for preventing and treating abuse of addictive drugs like opioids, a problem that is surging in GOP and Democratic represented communities around the country.
Democrats and consumer groups were upset with the bill’s streamlining of some Food and Drug Administration processes, including making it easier for companies to win approval for some antibiotic drugs, some medical devices considered breakthroughs and for fresh uses of some existing medicines.
The bill was backed by scores of patient groups and industry organizations including PhRMA, representing leading pharmaceutical firms and AdvaMed, the trade association for device makers.
