Who We Are

The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

The NJLSVA was founded to educate suppliers on trends in industry procurement and public policy that affects the life sciences industry.

21st Century Cures Act

FDA Announces Comprehensive Regenerative Medicine Policy Framework

Washington, DC, November 20, 2017 — The U.S. Food and Drug Administration (FDA) on November 16 announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. Continue reading

Senate Appropriators Approve $2 Billion Raise for NIH in 2018

Washington, DC, September 8, 2017 — Lev Facher reports on STAT that the U.S. Senate appropriators on September 7 approved a plan that would increase spending for the National Institutes of Health (NIH) by $2 billion and maintain nearly $300 million in grants for family planning programs that a House committee had sought to eliminate.

The plan would also fund the Substance Abuse and Mental Health Services Administration (SAMHSA) by $387 million more than the amount recommended by President Trump’s budget blueprint.

The bill approved by the Senate Appropriations Committee is perhaps a best-case scenario for boosters of the NIH, family planning advocates, and those fighting the opioid crisis. Continue reading

U.S. House Subcommittee Defies Trump’s Budget and Proposes $1.1 Billion Boost for NHI

Washington, DC, July 13, 2017 — Rachel Roubein reports in The Hill that the U.S. House of Representatives subcommittee controlling the purse strings of the National Institutes of Health (NIH) on July 12 proposed a $1.1 billion boost for the agency, defying the Trump administration’s push for cuts.

The White House had proposed slashing the nation’s medical research agency by $5.8 billion.

But it was clear from the get-go that Congress wouldn’t support cutting NIH’s budget, with members of both parties in opposition. Continue reading

FDA Commissioner Gottlieb Ends Trump’s Hiring Freeze at Agency

Washington, DC, June 7, 2017 — Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has pulled the plug on the hiring freeze President Donald Trump imposed on the agency.

The moves will allow the FDA to fill vacancies to shape an agency capable of enacting his plans for how safety and efficacy information are gathered during development. Continue reading

Rebuffing Trump’s Call for Cuts, Congress Boosts NIH Funding by $2 Billion

Washington, DC, May 1, 2017 — Lev Facher reports in STAT that the National Institutes of Health will get a $2 billion funding boost over the next five months, under a bipartisan spending deal reached late Sunday night in Congress.

The agreement marks a sharp rejection of President Trump’s proposal to cut $1.2 billion from the medical research agency in the current fiscal year.

The deal does not address funding for 2018, when Trump has called for a slashing the NIH’s budget by about a fifth, or $5.8 billion. Continue reading

Trump’s Budget Proposes 18 Percent Cut for NIH; $26 Billion Lowest in 15 Years

President Donald Trump

Washington, DC, March 16, 2017 — Thomas M. Burton reports in The Wall Street Journal that funding for the National Institutes of Health (NIH), the nation’s premier medical research funding agency, would be cut by 18 percent, or $5.8 billion, from levels enacted for fiscal 2017, under the Trump administration budget.

The NIH’s budget would total just under $26 billion, the lowest level in 15 years.

The Trump administration’s plan appears to put it on a collision course with leaders of both parties in Congress. Continue reading

President Obama Signs 21st Century Cures Legislation; Aims to Accelerate Medical Innovation

President Barack Obama

President Barack Obama

Washington, DC, December 14, 2016 — President Obama signed legislation Tuesday that aims to increase funding for medical research, speed the development and approval of experimental treatments and overhaul federal policy on mental health care, Juliet Eilperin and Carolyn Y. Johnson report in The Washington Post.

“We are bringing to reality the possibility of new breakthroughs to some of the greatest health-care challenges of our time,” President Obama said.

“It is wonderful to see how well Democrats and Republicans in the closing day of this Congress came together around a common cause,” Obama said.  “And I think it indicates the power of this issue and how deeply it touches every family across America.” Continue reading

Congress Passes 21st Century Cures Act; President Obama Praises Bill to Accelerate Medical Innovation

21st-century-cures-blueWashington, DC, December 8, 2016 — Mike DeBonis reports in The Washington Post that Congress passed sweeping legislation yesterday that boosts funding for medical research, eases the development and approval of experimental treatments and reforms federal policy on mental health care.

The 94 to 5 Senate vote Wednesday followed a 392 to 26 House vote last week.

The bill, known as the 21st Century Cures Act, now heads to the desk of President Obama, who praised the bill Wednesday and said he would sign it. Continue reading

U.S. House Approves 21st Century Cures Bill, A Sweeping Health, Medical Innovation Measure

21st-century-cures-blueWashington, DC, December 1, 2016 — Jennifer Steinhauer and Sabrina Tavernise report in The New York Times that the U.S. House or Representatives yesterday overwhelmingly passed a far-reaching measure — the 21st Century Cures Act — to increase funding for research into cancer and other diseases, address weaknesses in the nation’s mental health systems and help combat the prescription drug addictions that have bedeviled nearly every state.

In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), co-authors of the bill, said, “21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need.”

“The White House has expressed its enthusiastic endorsement of this critical legislation,” Upton and DeGette said.  “So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow.” Continue reading

Long-Stalled 21st Century Cures Act Sits on Senate’s Lame-Duck Calendar

Capitol Dome HEALTHCAREWashington, DC, November 24, 2016 — Steven Findlay reports in The Washington Post that Republicans in Congress are pushing to pass long-stalled legislation by December that gives the Food and Drug Administration (FDA) new powers to more rapidly approve drugs and medical devices.

Over five years, the complex legislation would include $550 million in additional funding for the agency, plus upward of $1 billion annually in added spending for the National Institutes of Health.

The bills have had bipartisan support in Congress during the past two years. Continue reading